CALIFORNIA STATE UNIVERSITY, NORTHRIDGE
THE EFFECTS OF "TWINGES IN THE HINGES" ON
FIBROMYALGIA SYNDROME
A graduate project submitted in partial fulfillment of the requirements
for the degree of Master in Physical Therapy
by
Nancy D. Rogers
in collaboration with
Renata Decher
Heidi Whitney
June 2002
The Graduate Project of Nancy Rogers is approved:
Date
St" ven
' F. Loy, Ph.D.(J
Sue Mintz, PT
v·
Date
Diana J. Osterhues, DPT., OCS., COMT, Chair
Date
California State University, Northridge
ii
-
ACKNOWLEDGEMENTS
I would like to express my sincere gratitude to my father, John K. Rogers,
whose encouragement, unconditional love and support has enabled my dreams
of yesterday to become a reality, my brothers Bill Rogers and Richard Rogers
who have been there for me in my life's toughest moments, my sister Katy for
her encouragement, and my mother and twin brother David who are always
beside me.
I would like to thank my research partners Renata Decher and Heidi Whitney
for their incredible support, advice, and for enduring this Graduate Project with
me to it's completion.
I would like to extend my sincere gratitude to my Committee Chair, Dr. Diana J.
Osterhues, whose guidance and mentorship have been invaluable for the
completion of this Graduate Project, and for facilitating my personal and
professional growth. Dr. Steven F. Loy, for his advice, and to Sue Mintz, who
so graciously gave us her time and professional judgment as the instructor of
"The Twinges in the Hinges" program and enabled us to bring the academic
world and clinical world a little closer. I would also like to thank her assistant,
Danielle Wiswall. A special thank you to Dr. Janet M. Adams, for her
contribution with statistical analysis, Tom Fisher, and Saint Francis Medical
Center of Santa Barbara for the use of the therapeutic pool and to Felicia
Carroll and Ma~orie Shore who have been mentors throughout this process.
I recognize the above mentioned have demonstrated commitment and service
to our profession. Because of their contribution there is a gift given beyond that
of this project. They have facilitated a "rite of passage", a transformation from a
student to a professional, and a companionate aspiring clinician.
Onward and Upward -
iii
'
...
TABLE OF CONTENTS
SIGNATURE PAGE..................................................................................
ii
ACKNOWLEDGEMENTS.........................................................................
iii
ABSTRACT...............................................................................................
vi
JOURNAL ARTICLE.................................................................................
1
Patients and Methods...................................................................
3
Statistical Analysis........................................................................
4
Results..........................................................................................
5
Discussion.....................................................................................
5
Figures..........................................................................................
8
References....................................................................................
11
PROPOSAL.............................................................................................
14
Review of Literature......................................................................
17
Diagnosis of Fibromyalgia Syndrome.................................
17
Pathology............................................................................
18
Prevalence..........................................................................
20
Symptoms...........................................................................
21
Signs...................................................................................
22
Functional Limitations.........................................................
23
Psychological Problems.....................................................
24
Treatments.........................................................................
25
iv
p
PROPOSAL Gont.
.
The 'Twinges in the Hinges" Aquatic Program.................
32
Assessment.......................................................................
35
Methods. and Materials.................................................................
38
Subjects.............................................................................
38
Procedures........................................................................
40
REFERENCES........................................................................................
44
APPENDICES.........................................................................................
49
A
Fibromyalgia Impact Questionnaire ................................. .
49
B
Screening Questionnaire ................................................. .
51
c
Diagnosis Verification Form ............................................. .
53
D
Rights of Human Subjects in Medical Experiments ..........
55
E
Subject Consent Form ..................................................... .
56
F
Lesson Plan Example ...................................................... .
59
v
ABSTRACT
The Effects of "Twinges in the Hinges" on
Fibromyalgia Syndrome
by
Nancy D. Rogers
Master of Physical Therapy
This study examined the effects of "Twinges in the Hinges", a
recreational aquatic program, on individuals with Fibromyalgia Syndrome
(FMS). Twenty-two female subjects aged 30 to 59, diagnosed with FMS by
physicians according to the criteria defined by the American College of
Rheumatology 1990 guidelines, volunteered for the study. Eleven of 22 subjects
completed the study, resulting in an attrition rate of 50%. The Fibromyalgia
Impact Questionnaire (FIQ) was used to assess functional capability, pain, and
fatigue. Although average scores improved after six weeks of treatment and
five weeks post treatment, there was no statistically significant difference
(p<0.05) among total FIQ scores (p=0.78 and 0.60), pain subscores (p=0.98
and 1.00), and fatigue subscores (p=0.61 and 0.06). Given the positive
anecdotal responses provided by the participants, the authors believe that there
is benefit from participation in warm water exercise for individuals with
Fibromyalgia Syndrome.
vi
JOURNAL ARTICLE
THE EFFECTS OF "TWINGES IN THE HINGES" ON
FIBROMYALGIA SYNDROME
Fibromyalgia Syndrome (FMS) is a rheumatic disease characterized by a
history of widespread pain upon digital palpation of tender points 28 . The disorder
of FMS has also been known as Fibrositis 9·18·22 and non-articular rheumatism 18 .
Fibromyalgia Syndrome is the most common cause of widespread muscular
pain 15 and affects approximately six million Americans 10 . Despite the fact that
there is an established diagnostic criteria 28 , the etiology of FMS is still not
27
14
understood 20 • and there is no cure 13 ·
.
The treatment of FMS consists of managing the symptoms, which include
fatigue, sleep disturbance, morning stiffness, pain, paresthesias, headaches and
anxiety28 . A variety of traditional and nontraditional approaches are used
including massage, relaxation therapy, medication, education, physical therapy,
behavior modification, and exercise programs. Physicians prescribe exercise for
FMS patients to increase circulation and to improve general fitness, flexibility and
well-being
24
.
Exercises involving impact have been shown to increase pain at
tender points, therefore, Sherman recommended an exercise regimen
encompassing low impact movements since symptoms of FMS are exacerbated
by weight-bearing exercises 24 · Aerobic exercise in water is indicated for FMS
patients in order to break the cycle of pain and fatigue, increase range of motion,
24 25
• .
and improve overall health 17 •
Aquatic therapy provides an avenue for FMS patients to exercise without
the adverse effects of impact on joints 7 . McNeil and Routi et al. found that
buoyancy decreased joint compression and enhanced relaxation 17 ·21 . Hall et al.
determined that the combined effects of warm water immersion and exercise in
water are therapeutically superior to either used exclusively 12 . The many
benefits of aquatic therapy make it an ideal treatment for FMS 7 .
Levin et al. contended that patients with illnesses who cannot tolerate land
exercises due to the effects of gravity on muscles and joints, athletes recovering
from injury, as well as patients with arthritis and spinal cord injuries, can benefit
from aquatic therapy 16 . According to several studies, the goals of aquatic
therapy are: 1) reduce pain and inflammation, 2) increase range of motion ,.
flexibility and strength, 3) increase endurance, and 4) improve overall health and
well-being 11, 1s.19,21 _
The "Twinges in the Hinges" program is a recreational aquatic program
which can be carried out in warm (96 to 98°F) or cool water (86 to 89°F). This
program is endorsed by the Arthritis Foundation and the YMCA and is nationally
recognized as beneficial for patients with rheumatological diseases 2 . The
program focuses on exercises which are purported to increase range of motion,
strength, conditioning, functional abilities, as well as provide pain relief. This
program has gained popularity by participants who anecdotally report a decrease
in pain and improvement in joint mobility, while enjoying the benefits of a social
setting 2 .
An extensive search failed to reveal any published clinical studies on the
effects of the "Tv.iinges in the Hinges" program on rheumatic diseases. The
purpose of this study was to explore the short and long-term effects of "Twinges
2
in the Hinges" on individuals diagnosed with FMS by analyzing data collected
after six weeks of treatment and five weeks post treatment.
PATIENTS AND METHODS
Subjects Twenty-two female volunteers were solicited from Arthritis
Foundation self-help meetings, FMS support groups, physicians, and other
health professional referrals. In order to be included in the study individuals must
have been diagnosed with FMS by a physician according to the American
College of Rheumatology (ACR) guidelines 28 . Participant inclusion criteria were
female, aged 21 years or older, willing to participate in a group setting , could
follow directions, read and understand English, and be able to ambulate with or
without an assistive device. Exclusion criteria included: open wounds, unstable
and/or uncontrolled medical conditions, wide spread osteoarthritis, and
susceptibility to ear infections. Subjects agreed not to begin new exercise
programs for the duration of the study.
Methods. Prior to the study, subjects completed a screening
questionnaire to assess the above inclusion/exclusion criteria and signed an
institutionally approved consent form . The Fibromyalgia Impact Questionnaire
(FIQ) was used to obtain data throughout the study. The FIQ is a three-part, selfreport questionnaire designed to assess various aspects of functional ability and
health in individuals with FMS. Part one evaluates how often the individual is
able to perform common tasks of daily living and part two addresses work
attendance and genera! we!!-being . The third section uses a visual analog scale
to assess pain, fatigue, sleep, stiffness, anxiety, nervousness and depression. A
lower total FIQ score demonstrates a better overall functional ability. The
3
reliability and validity of the FIQ have been established in several studies 3·5·6·20 .
For all questionnaires, subjects were instructed to answer the questions
relative to how they felt during the previous week. Subjects completed the pretreatment FIQ (one week pre) immediately preceding the first aquatic treatment.
Subjects were instructed to fill out a FIQ before each successive treatment.
Following six weeks of treatment, subjects completed questionnaires to represent
how they felt two (2 weeks post) and five weeks (5 weeks post) after the last
treatment.
The six treatments were performed on Saturdays between the hours of
twelve and two p.m. by a certified "Twinges in the Hinges" practitioner. The
temperature in the pool was 97-98 degree Fahrenheit. Similar exercise
techniques were used in all treatment sessions. Each treatment session began
with a five minute warm up, a 25-35 minute exercise interval, and a five minute
cool down period. The exercises, which emphasized underwater movements,
progressed from 8 to 20 repetitions. The sequence and general categories of the
exercises were as follows: breathing and chest expansion, walking, neck
movements, trunk flexibility, and upper and lower extremity movements.
Subjects were asked to leave the pool promptly upon completion of the sessions.
STATISTICAL ANALYSIS
In view of the attrition rate of 50%, the remaining sample size of 11
individuals was calculated to be below the appropriate size for this study, based
on an alpha= 0.05 level, 80% power, and a large effect size. A repeated
measure ANOVA (p<0.05) was utilized to determine statistical significance for the
total FIQ score, FIQ pain subscore, and FIQ fatigue subscore. To interpret the
4
distribution of data for pain and fatigue, parametric (Repeated Measures) was
applied. Descriptive statistics were calculated for onset of FMS.
RESULTS
. Eleven of the initial 22 subjects completed the study. Seven subjects
were advised by their physician to discontinue secondary to health complications
of cancer, chronic fatigue syndrome, cardiac complications, and foot surgery.
Two subjects completed the aquatic program but did not comply with reporting of
questionnaires. One subject discontinued due to personal travel needs. One
subject gave no reason for discontinuing. The remaining subjects' ages were
between 30-60 years, with 60% falling in the 50-59 year old category. The mean
onset of FMS symptoms was 8.6 years, with a standard deviation of 11 .8 years.
Eighty percent of the subjects had an onset of 8.0 years or below, with a median
onset of 4 years (Figure 4).
No statistically significant differences were found in total FIQ scores
(Figure 1), pain subscores (Figure 2) and fatigue subscores (Figure 3) after six
weeks of treatment and five weeks post treatment. The p-values after six weeks
of treatment were: total FIQ scores (p=0.78), pain subscores (p=0.98), .and
fatigue subscores (p=0.61) . The p-values after five weeks post treatment were:
total FIQ scores (p=0.60), pain subscores (p=1 .00), and fatigue subscores
(p=0.06) . These results demonstrate that in our subject group, "Twinges in the
Hinges" did not significantly improve FIQ, pain and fatigue scores.
DISCUSSION
The lack of significant improvement in total FIQ scores or pain and fatigue
subscores could be due to the large variability among the subjects, as also noted
5
by Buckelew et al. 4 and Cote et al. 8 . For example, the onset of the signs and
symptoms ranged from 1.5 years to 40 years (Figure 4). The pre-treatment FIQ
scores ranged from 24.9 to 80.3 points (Figure 5) with a mean score of 63.0 and
standard deviation of 18.3. These variances, combined with the small sample
size, may have contributed to a Type II statistical error.
Subjects with FMS are a challenging research population secondary to
highly fluctuating daily signs and symptoms and the psychological sequelae of
depression, which commonly accompany this diagnosis 26 . As indicated, with an
attrition rate of 50%, the resulting small sample size of eleven subjects may have
contributed to the lack of significant results. Sandstrom et al. found that there is
a methodologic concern regarding attrition rates across studies involving subjects
with FMS 23 . Agargun et al. also stated that a limitation to their study was a
relatively small sample size 1.
Although there was no statistically significant difference in the data, there
was a trend towards improvement in total FIQ scores, pain subscores, and
fatigue subscores after six weeks of treatment and five weeks post treatment.
Raw FIQ scores as well as anecdotal evidence seem to indicate that "Twinges in
the Hinges" could be a valuable intervention to improve signs and symptoms of
FMS.
Given the problems encountered and the positive anecdotal responses
provided by the participants, the authors believe that there is benefit from
participation in warm water exercise for individuals with FMS. !tis recommended
that further research based on the warm water exercise program, "Twinges in the
Hinges", be conducted. However, a more homogeneous group of subjects would
6
be advisable, as other researchers have found 4 ·8 . Subjects may be grouped into
the following categories: similar age, onset of symptoms, severity of symptoms at
the start of the program, prior level of function, and overlying medical conditions
(diabetes, chronic fatigue syndrome, arthritis, etc.). Recommendations for future
studies include a larger sample size, a control group, and a longitudinal design to
compensate for the fluctuations of signs and symptoms characteristic of
Fibromyalgia Syndrome. Given the numbers of individuals with FMS, it is
important to continue applied research efforts to explore possibilities to improve
the quality of life for this population. The population is a challenging one to
involve in research studies and a significant effort must be made to create the
ideal circumstance to evaluate experimental intervention.
7
Figure 1. Total FIQ Scores with corresponding p-values
FIQ Scores
800 ,-~--~~---~..-~~~~~~~~~~~~~--~--~~~~-.
700
600
500
400
300
200
100
0
l= Total FIQ Scores
I
• Scores reflect the combined total FIQ scores of all subjects during each week.
Figure 2. FIQ Pain Subscores with corresponding p-values
Pain Scores
100
90 +-~~~~~~~~~~~~~~~~~~~~~~~~~~~--;
80 +-~~~~~~~~~~~~~~~~~~~~~~~~~~~--;
70
60
50
40
30
20
10
0
!• Total Pain Scores I I
• Scores reflect the combined total FIQ subscale scores for Pain for of all subjects during each week.
8
Figure 3. FIQ Fatigue Subscores with corresponding p-values
Fatigue Scores
100
90
80
70
60
50
40
.........~---~.........~~~~....-~............,._~~~~.......
.----~~~~~~~~
+-~~~~~~~~~~~~~~~~~~~~~~~~~~-,
30
20
10
0
!• Total Fatigue Scores
• Scores reflect the combined total FIQ subscale scores for Fatigue for of all subjects during each week.
9
I
Figure 4. Onset of Fibroymyalgia Syndrome Signs and Symptoms
YEARS
FREQUENCY
1.5
2
3
5
6
8
16
40
2
1
2
1
1
1
1
1
VALID PERCENT CUMULATIVE PERCENT
20
10
20
10
10
10
10
10
40
30
50
60
70
80
90
100
Figure 5. Fibromyalgia Impact Questionnaire Scores Pre-Treatment
SCORES
FREQUENCY
24.91
32 .59
62.30
62.63
63.65
67.36
68.42
72.94
78.37
79.96
80.32
1
1
1
1
1
1
1
1
1
1
1
VALID PERCENT. CUMULATIVE PERCENT
9.1
9.1
9.1
9.1
9.1
9.1
9.1
9.1
9:1
9.1
9.1
• Data reflects the large variance in pre-treatment FIQ scores.
10
9.10
18.20
27.30
36.40
45.50
54.50
63.60
72.70
81.80
90.90
100.00
REFERENCES
1.
Agargun MY, Tekeoglu I, Gunes A, Adak B, Kara H, Ercan M. Sleep
quality of Pain Threshold in Patients With Fibromyalgia. Comprehensive
Psychiatry. 1999 June; 4(3) : 226-228.
2.
Arthritis Foundation. Arthritis Foundation YMCA Aquatic Program
(AFYAP) and AFYAP Plus. Instructor's Manual. 1996. Atlanta, GA.
3.
Bennett RM, Burckhardt CS, Clark SR, O'Reilly CA, Wiens AN, Campbell
SM. Group Treatment of Fibromyalgia: a 6 Month Outpatient Program.
The Journal of Rheumatology. 1996 March; 23(3): 521 -528. (Latest
article)
4.
Buckelew SP, Murray SE, Hewett JE, Johnson J, Huyser B. SelfEfficacy, Pain, and Physical Activity Among Fibromyalgia Subjects.
Arthritis Care and Research. 1995 March; 8(1): 43-50.
5.
Burckhardt CS, Clark SR, Bennett RM. The Fibromyalgia Impact
Questionnaire: development and validation. J Rheumatol.
1991 ;18:728-733.
• 6.
Buskila D, Neumann L. Assessing functional disability and health status
of women with fibromyalgia: validation of a Hebrew version of the
Fibromyalgia Impact Questionnaire. J Rheumatol. 1996;23:903-906.
7.
Cirullo JA. Aquatic physical therapy approaches for the spine.
Orthopedic Physical Therapy Clinics of North America. 1994;3
(2): 179-208.
8.
Cote KA, Moldofsky H. Sleep, Daytime Symptoms, and Cognitive
Performance in Patients with Fibromyalgia. The Journal of
Rheumatology. 1997 April; 24(10): 2014-2023.
9.
Danneskiold-Samsoe B, Christiansen E, Lund B, Andersen RB.
Regional muscle tension and pain ("fibrositis"). Scand J Rehab Med.
1982; 15(1): 17-20.
10.
Goldenberg DL. Fibromyalgia Syndrom: An Emerging But Controversial
Condition. JAMA. 1987; 257: 2782-2787.
11.
Hall J, Skevington S. A randomized and controlled trial of hydrotherapy
in rheumatoid arthritis . Arthritis Care and Research. 1996;9(3):206-215.
ll
12.
Harrison, RA, Bulstrode S. Percentage weight bearing during partial
immersion in the hydrotherapy pool. Physiotherapy Practice. 1987;3:6063.
13.
Henriksson CM, Long term effects of fibromyalgia on everyday life. A
study of 56 patients. Scandinavian Journal of Rheumatol.
1994;23(1 ):36-41.
14.
Henriksson CM, Gundmark I, Bengtsson A, and Ek AC. Living with
fibromyalgia: consequences for everyday life. The Clinical Journal of
Pain. 1992;8:138-144.
15.
Keel PJ, Bodoky C, Gerhard U, Muller W. Comparison of Integrated
Group Therapy and Group Relaxation Training for Fibromyalgia. The
Clinical Journal of Pain. 1998; 14: 232-238.
16.
Levin S. Aquatic Therapy. The Physician and Sportsmedicine. 1991
October; 19(10): 119-126.
17.
McNeal R. Aquatic therapy for patients with rheumatic disease. Exercise
and Arthritis. 1990;16(4):915-929.
18.
Moldofsky H; Warsh J. Plasma Tryptophan and Musculoskeletal Pain in
Non-Articular Rheumatism ("Fibrositis Syndrom"). Pain. 1978; 5: 65-71.
,
.
19.
Poteat AL, Bjerke MD, Johnston TD, Mairs JP. Evidence-Based Aquatic
Therapy: Building a Case for Use of Aquatic Physical Therapy for
Fibromyalgia Patient Populations. The Journal of Aquatic Physical
Therapy. 1997 July; 5(2): 8-21.
20.
Rossy LA, Buckelew S, Hagglund KJ, Thayer JF, Mcintosh MJ, Hewett
JE, Johnson JC. A Meta-analysis of Fibromyalgia Treatment
Interventions. The Society of Behavioral Medicine. 1999, 2(2): 180-191.
21.
Ruoti RG, Troup JT, Berger RA. The Effects of Nonswimming Water
Exercises on Older Adults. JOSPT. 1994 March; 19(3): 140-145.
22 .
Russell lJ, Michalek JE, Vipraio GA, Fletcher EM, Javers MA, and
Bowden CA. Platelet H-lmipramine uptake receptor density and serum
serotonin levels in patients with fibromyalgia/fibrositis syndrome. The
Journal of Rheumatology 1992;19: 104-109.
23.
Sandstrom MJ, Francis J K. Self-Management of Fibromyalgia: The
Role of Formal Coping Skills Training and Physical Exercise Training
Programs. Arthritis Care and Research. 1998 December; 11 (6): 432447.
12
24.
Sherman C. Managing fibromyalgia with exercise. The Physician and
Sportsmedicine.1992;20(10):166-172.
25.
Templeton MS, Booth OL, O'Kelly WO. Effects of Aquatic Therapy on
Joint Flexibility and Functional Ability in Subjects With Rheumatic
Disease. Journal of Sports Physical Therapy. 1996 June; 23(6): 376-381.
26.
Walker EA, Keegan 0, Gardner G, Sullivan M, Bernstein 0, Katon WJ.
Psychosocial Factors in Fibromyalgia Compared with Rheumatoid
Arthritis: II . Sexual, Physical, and Emotional Abuse and Neglect.
Psychosomatic Medicine. 1997; 59: 572-577.
27.
Wigers SH, Stiles TC, Vogel PA Effects of Aerobic Exercise Versus
Stress Management Treatment in Fibromyalgia. A 4.5 Year Prospective
Study. Scand J Rheumatol. 1996; 25: 77-86.
28.
Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C,
Goldenberg DL, et al. The American College of Rheumatology 1990
criteria for the classification of fibromyalgia. Arthritis and Rheumatism.
1990 Feb;33:160-172.
13
PROPOSAL
INTRODUCTION
"One day I was fine and going on with my life, and the next day I had this
pain that has changed the course of my life"3 . Unfortunately, these are words
•
commonly expressed by patients diagnosed with Fibromyalgia Syndrome
(FMS)3. The disorder of FMS has also been known as Fibrositis 15 ·35 ·44 and
non-articular rheumatism 35 . FMS is a rheumatic disease characterized by a
history of widespread pain and pain upon digital palpation of tender points 55 .
FMS is the most common cause of widespread muscular pain 27 . FMS affects
approximately 6 million Americans 19 . Despite the fact that there is a set
diagnostic criteria 55 , the etiology of FMS is still not understood 41 ·51 and there is
no cure 24 ·26 .
The treatment of FMS consists of the management of symptoms. A
variety of traditional and nontraditional approaches are used. Medications such
as Low-Dose Non-steroidal Anti-inflammatory or Non-narcotic drugs are
commonly prescribed for FMS patients to alleviate pain and sleep
disturbances 20 ·43 ·47 .
Physicians prescribe exercise for FMS patients to increase circulation
and to improve general fitness, flexibility and well-being. However, exercises
involving impact increased pain at tender points4 7, therefore, Sherman
recommended an exercise regimen encompassing low impact movements.
Nichols et al suggested aerobic walking for improved pain ratings 36 .
14
Interdisciplinary treatments integrate various disciplines consisting of
physicians, physical therapists, psychologists, and occupational therapists
49
.
Using this treatment method, Turk et al found improvements in perceived
physical impairments, severity of pain, self-efficacy, fatigue, depression, and
anxiety
49
.
In a study by Burckhardt et al it was found that physical exercise and
education together had significant positive impact on self-efficacy of patients
with FMS 11 . A review conducted by Rossy et al compared 49 treatment studies
and concluded that treatments with an emphasis on exercise and cognitive
behavioral therapy, in conjunction with management of medications for sleep
and pain, is the optimal intervention for FMS 41 .
Symptoms of FMS are exacerbated by weight-bearing exercises47 .
Aquatic therapy provides an avenue for FMS patients to exercise without the
adverse effects of impact on joints 13 . McNeil et al and Routi et al found that
buoyancy decreased joint compression and entranced relaxation 34 .42 .
According to Sherman, aerobic exercise in water is indicated for FMS patients
in order to break the cycle of pain and fatigue and improve overall health 47 . Hall
et al found that "the combined effects of warm water immersion and exercise in
water are therapeutically superior to either used exclusively"23 . The many
benefits of aquatic therapy make it an ideal treatment for FMS.
The "Twinges in the Hinges" program is a warm water recreational
aquatic program that is endorsed by The Arthritis Foundation and the YMC,a,3 _
This program is nationally recognized as beneficial for patients with
15
rheumatological diseases and focuses on exercises which are purported to
increase range of motion, strength and conditioning . This program has gained
popularity by participants who anecdotally report a decrease in pain and
improvement in joint mobility, while enjoying the benefits of a social setting 3 .
The hypothesis of this research is: "Twinges in the Hinges", a low impact
recreational aquatic exercise program, endorsed by the American Arthritis
Foundation, is effective in reducing pain and increasing functional abilities in
patients diagnosed with Fibromyalgia. The purpose of this study is to determine
the effects of the "Twinges in the Hinges" aquatic recreational program on
patients with FMS.
Specific Aims
•
To determine the effects of ''Twinges in the Hinges" on the quality
of life on individuals with Fibromyalgia as assessed by the
Fibromyalgia Impact Questionnaire (FIQ).
•
To determine the effects of "Twinges in the Hinges" treatment on
quality of life in individuals with fibromyalgia compared to
individuals with Fibromyalgia who received no treatment.
•
To determine the residual effects of "Twinges in the Hinges" on
individuals with Fibromyalgia after each session and at one, three
and six weeks after the last treatment.
16
LITERATURE REVIEW
Diagnosis of Fibromyalgia Syndrome
The diagnostic criteria developed by the American College of
Rheumatology in 1990 are well-accepted and widely used 5·53 . FMS can be
identified, with high sensitivity (88.4%) and specificity (81.1 %), from other
rheumatic conditions by the use of the two-stage criteria set forth by the
American College of Rheumatology55 . This two-stage criteria for the
classification of FMS is as follows: 1) a history of widespread pain present for
at least three months and 2) pain in 11 of 18 tender point sites on digital
palpation. According to Wolfe et al, pain is considered widespread when all of
the following are present: pain in the left side of the body, pain in the right side
of the body, pain above and below the waist, and pain in the axiai skeieton.
When assessing tender points, digital palpation should be performed with a
force of 4kg and the subject must state that the palpation was painful 55 . No
specific diagnostic criteria from blood tests for the disorder of FMS is available,
however, researchers are trying to discover a laboratory test that will diagnose
FMS 5 .
FMS has been divided into two different types; primary and secondaryconcomitant55 . Primary FMS occurs in the absence of another specific
condition, whereas secondary-concomitant FMS occurs in the presence of
another rheumatic disorder. The American College of Rheumatology, however,
found the primary and secondary-concomitant groups to be essentially
17
indistinguishable and suggested there should be no distinction when
diagnosing FMS 55 .
Despite the fact that there is set diagnostic criteria for FMS, it is often a
difficult disorder for the clinician to diagnose53 . Wolfe suggested that there are
apparent non-medical factors that shape the physical manifestations of the
syndrome that are hard to identify or measure, for example, genetics, social
activity, psychological status, work and family 53 . Some subjects with FMS
report tenderness and pain throughout their entire body53 . Wolfe et al suggested
such pain behavior is associated with significant psychiatric disorders and that
the diagnosis of these patients using the diagnostic criteria set forth by the
American College of Rheumatology becomes questionable53 .
Wolfe et al pointed out that in the clinic the diagnosis of FMS is rarely
questioned because the clinicians have some knowledge about the validity and
reliability of the symptoms associated with the diagnosis of FMS. However,
within the setting of workers compensation, work injury, disability, or litigation,
the diagnosis of FMS may be questioned, due to the possibility that both the
tender point count and dolorimetry pain score can be manipulated by the patient
for his/her own personal financial gains 53 .
Pathology
The etiology of FMS is still not understood 41 •51 . Bennet et al pointed out
that the cause of FMS is questionable and the syndrome is considered a cluster
of signs and symptoms rather than a distinct disease entity; the pain FMS
18
patients feel is real 6 . Walker et al suggested that victimization in childhood, as
well as sexual, physical and emotional trauma may have some role in the
etiology and occurrence of FMS 50 .
In 1977, Moldofsky et al suggested that alterations in tryptophan could
result in reduced serotonin function in the brain and thus contribute to a
hyperalgestic state 35 . The study concluded that a disturbance in central nervous
system (CNS) serotonin metabolism may underlie the non-REM (stage IV)
sleep disturbance, pain and depressive symptoms in patients with the "fibrositis
syndrome"
1 2 35 44
• • · .
Agargun et al found that substance P discharge is
influenced by serotonin, and that a serotonin deficiency in the CNS may cause
an exaggerated perception of pain stimuli2.
Wolfe et al suggested that persistent nociceptive input leading to
sustained hyperalgesia might be one of the mechanisms that cause FMS 54 .
Three other suggestions of cause of FMS from this study were that patients with
FMS may have a somatization disorder, a hyper-irritability problem, or a
psychosocial abnormality manifested by psychological distress, reduced income
and education, and higher rates of divorce 54 .
Danneskiold-Samsoe et al suggested that regional muscle pain in
"fibrositis" is a disorder of muscle fibers 15 • They suggested that an increase in
myoglobin in plasma after a massage treatment was thought to indicate a leak
of myoglobin from muscle fibers, suggesting muscle tension and pain was
associated with a disorder of muscle fibers . The study found a correlation
between the "fibrositis" index and increased plasma myoglobin 15 . Buckelew at
19
al suggested that the absence of stretching may contribute to the experience of
pain in FMS
7
.
Bennet et al suggested two other possible causes of FMS;
artificially disrupted sleep and augmented response to pain sensations due to
"rewiring" of the CNS (neuroplasticity)6.
Prevalence
FMS is one of the most common disorders seen by rheumatologists 41
and is the third most commonly diagnosed rheumatic disorder2 9 . It is the most
common cause of widespread musculoskeletal pain 27 and is recogn ized in most
parts of the world 25 . FMS affects approximately 6 million Americans 19 . The
typical patient with FMS is most likely a caucasian woman 6 . Onset of FMS is
typically seen between the age of 20 and 506 . Karen Moore Schaefer reported
that of 100 patients diagnosed with the syndrome, 73 to 88 were women 46 .
Wolfe et al studied a random sample of 3,006 persons in the city of
Whichita, Kansas to determine the prevalence of FMS in the general
population 54 . The estimated prevalence in this population was 2%. They found
the estimated prevalence for women to be 6.8 times greater than that of men.
The study also reported that the disorder is most commonly seen in women
aged 50 and above, not in young women as many had thought. In the 18-30
year age group, the percentage of women with the disorder was 0.9 %, 2.0 % in
the 30-39 age group, 5.6% in the 50-59 age group and 7.4% in the 70-79 year
age group 54 .
20
Wolf et al found that FMS was shown to have an association with failure
to complete high school, reduced household income, history of depression,
visits to the physicians, and applications for disability benefits 54 . However,
Burckhardt et al found no relationship between education and increased
functional impairments associated with FMS 9·10 . Bennett at al found that 33% of
patients with Lupus, 25% with rheumatoid arthritis, and up to 50% of those with
Sjorgren's syndrome also have FMS 6 .
Symptoms
Wolfe et al's study found the most characteristic symptoms of FMS to
include fatigue, sleep disturbance (11waking unrefreshed 11 ), and morning
stiffness 55 . Moderately common symptoms were 11 pain all over11 , paresthesias,
headache, and anxiety55 . The pain itself may vary from burning to sore, stiff,
aching, or gnawing 6 . Less common symptoms were irritable bowel syndrome,
sicca symptoms, and Raynauld's phenomenon 55 . There may be a change in
symptoms from factors such as weather, poor sleep, stress and activity53 ·55 .
Many studies found sleep disturbance to be a major problem 1·2 •26 •35 .
Henriksson et al found that 53% of persons never awoke feeling refreshed, 36%
sometimes awoke refreshed and 11 % usually awoke refreshed 26 . Thus,
nonrestorative sleep was a good indicator of FMS 6 . FMS has also been
characterized as a disorder involving tendinous attachments (an ethesopathy)
and an increase in prevalence of articular pain 53 .
21
Wolfe found a strong association between the Rheumatology Distress
Index (ROI) and FMS 52 . He found there was a positive association between
distress and tender points 52 . Wolfe suggested it is extremely important to
recognize distress symptoms and trauma that may be associated with FMS 52 .
FMS can be characterized in the variations in the symptoms from one
day to the next, or from morning to the afternoon 14 •16 •25 . Patients diagnosed
with FMS must learn to cope with and manage a variety of symptoms45 .
Henricksson et al's study suggested the condition of FMS to be chronic and that
symptoms will not decrease or disappear2 4 •26 . However, Kennedy et al found
that patients perceived their symptoms to improved since diagnosis 28 •
Signs
Psychologic and behavioral characteristics of patients with FMS are
important because physicians may rely on these manifestations for diagnosis 53 .
The psychologic disorder of depression is commonly seen in patients with
FMS 28 . In the Kennedy et al study, two of the 39 patients had committed
suicide 28 . This rate was unexpected and the study suggested that physicians
need be advised that patients with FMS may be suffering from depression 28 .
Bennet et al stated that about 20% of patients with FMS currently have major
depression and that the lifetime incidence of depression is 45% 6 . The study
further suggested that any significant life stress can exacerbate the problems
associated with FMS 6 .
22
Henriksson et al mentioned that some patients accept a sick role which
enforces inactivity and thus may increase the cycle of inactivity, poor physical
fitness and further passivity26 . The study also pointed out that a lack of
motivation, central fatigue and other psychological factors may explain
decreased muscular strength in a patient2 6 .
Functional Limitations
Four stud ies agreed that symptoms associated with FMS often resulted
in a disability that influenced the patient's normal life and daily activity patterns
24 25 26
· • .
of work, home maintenance and leisure activities 6 •
Henriksson et al's
study of women with FMS found that 85% of the subjects reported changes in
their daily schedule since developing muscular pain 24 . One-third reported they
were dissatisfied with their daily schedule. Muscle fatigue was reported during
90% of the daytime activities and pronounced pain and fatigue were
experienced during 40% of waking hours. Eighty percent of the subjects rested
during the day and 15 of the 39 women subjects had left their jobs because of
FMS symptoms. A questionnaire in the study revealed 25% of the women found
housework activities unsatisfactory due to pain. Tasks took longer, more help
was needed, and less time was spent on housework 24 . Burckhardt et al found
that a subjects' age and the number of years presenting with FMS symptoms
were not related to function and that older 1Nomen who had the disorder longer
23
did not have a greater decreased function than that of younger women having
FMS for a shorter time period 1°.
Many subjects complained of disturbed cognitive function 14 , especially
forgetfulness, lack of patience and difficulty concentrating 25 . The Henriksson et
al study mentioned that many subjects were able to adapt their life roles and
live a satisfying life, despite their limitations 25 . They found that in order to
maintain a normal life, FMS patients had to organize and prioritize their daily
activities 25 . Wolf et al's study indicated that 75. 7% of persons with FMS had
seen a physician in the last 6 months, two-thirds took some form of pain
medication, 19.7% had applied for disability benefits, and 7.3% had received
disability benefits 54 .
Psychosocial Problems
Of the respondents in the Henriksson study, 73% found FMS symptoms
had consequences on relationships with family members24 . \/Valker et al
concluded that FMS is associated with increased risk of victimization,
particularly adult physical assaulf°. Potts et al found that FMS patients had a
low level of satisfaction with their physicians 39 . These patients found that in the
process of obtaining a correct diagnosis, they frequently had to consult several
physicians, some of whom had dismissed their concerns or labeled them as
hysterical, hypochondrical, or malingering 39 . Many people with FMS had started
to believe that the disorder was "all in their head" 46 . One study found that it took
from one month to 12 years to find an answer or diagnosis46 . In the process
24
many subjects had depleted all of their financial, physical, psychological and
social resources 46 .
Treatments
The treatments for FMS are multi-faceted, individualized and primarily a
management of symptoms with a treatment philosophy encompassing
strategies to deal with chronic pain 6 ·46 . Patients diagnosed with FMS typically
utilize traditional and non-traditional approaches to treatment.
There are numerous traditional treatments physicians prescribe for
management of FMS. Education 11 , exercise 32 •33 •36 •47 , medication 5 ·20 .43 A7 ,
physical therapy 38 •47 , and cognitive behavioral techniques 4 are the treatments
implemented.
Physicians prescribed exercise to increase circulation to muscles,
improve general fitness, flexibility, and well-being 47 . Sherman pointed out the
importance of implementing an exercise program by slowly increasing the
amount and intensity to prevent exacerbation of symptoms. Sherman further
explained patients became less active, resulting in deconditioning caused by
the ongoing cycle of pain and fatigue. He recommended brisk walking, biking
or swimming three to four times weekly for 30 minute duration. Exercise that
involved impact increased pain at tender points, which could cause "flare-ups"
of pain 47 . Sherman stated flare-ups may be caused by ove;exiending physical
activity or emotional stress 47 . Sherman suggested that a short-term (one to two
25
weeks) physical therapy treatment may eliminate or alleviate symptoms. He
suggested physical therapy treatments may include spray-and-stretch with
passive muscle stretch, electrical stimulation, heat modalities, and massage
47
.
Poteat et al further contended that such treatments, administered by physical
therapists, can promote long-term dependency38 . Poteat et al suggested that
this dependency does not encourage self-management and is not supported by
the current health care system 38 .
Several studies have reported on the effects of exercise on patients with
FMS 32 ·33 ·36 . Nichols et al studied the effects of aerobic exercise on
experimental and control groups of patients with FMS 36 . Subjects walked 20
minutes, at 60% to 70% of predicted maximum heari rate, three times weekly.
Pre-tests and post-tests were conducted using the McGill Pain Questionnaire
(MPQ), Sickness Impact Profile (SIP) and the Brief Symptom Inventory (BSI).
The study found that aerobic walking improved pain ratings. The SIP scores
involving the psychological component demonstrated improved psychological
profiles for the experimental group.
Nichols suggested that changes in SIP
scores may contribute to patients' improved psychological well-being, due to the
comradery and support drawn from shared experiences. The group sessions
provided physiological and psychological benefits. However, the items of
perceived disability on the SIP increased, possibly due to the •;perceived
increase in muscle stiffness and fatigue" resulting from this program 36 .
McCain et al conducted a randomized, controlled study of the effects of
cardiovascular fitness training with 42 patients with FMS 33 . A 20 week
26
cardiovascular fitness training (CVR) and a simple flexibility exercise program
(FLEX) were tested. The groups met three times weekly for 30 minutes. This
study revealed that CVR fitness training decreased pain intensity, as measured
by the Visual Analog Scale (VAS) . According to patient global assessment and
physician scores, CVR increased the pain threshold of tender points
significantly (P < 0.04). The McCain study found that exercise leads to
decreased sensitivity to pain. This study also suggested that exercise
increased levels of B-endorphin-like immunoreactivity adrenocortizotrophic
hormone, prolactin, and growth hormone 33 . Martin et al continued the study of
the effects of a more strenuous exercise program with patients with FMS 32 .
This study investigated flexibility, strength training, and aerobic activity. The
study consisted of a pre-test and post-test, utilizing several assessment tools on
60 subjects. The experimental group improved their aerobic fitness level ,
decreased degree of pain at tender points, and had fewer tender points. The
control group (relaxation) experienced no change in general health. Only 38
patients completed the study. Twelve patients dropped out due to self-report of
"lack of self-efficacy."
Medication is commonly prescribed for patients with FMS for the
treatment of pain and sleep disturbances. Medications for pain are typically
low-dose, non-steroidal anti-inflammatory or non-narcotic drugs47 . A study
carried out by Russell et al indicated that a combination of ibuprofen and
alprazolam may be effective for some patients with FMS43 . Corticosteroids and
immunosuppressive drugs and narcotics are contraindicated 6 . Further stud ies
27
by Goldenberg et al revealed tricyclic anti- depressants or muscle relaxants
enhanced stage IV sleep and elevated serotonin and other neurotransmitters of
the brain, which was found to be effective in reducing morning stiffness and
promoting restful sleep 20 .
Interdisciplinary treatment methods integrate various disciplines
consisting of physicians, physical therapists, psychologists, and occupational
therapists. Using interdisciplinary treatment, Turk et al found significant
statistical improvements in perceived physical impairments, severity of pain,
self-efficacy, fatigue, affective distress, depression and anxiety49 . The Reliable
Change Index showed improvement in pain severity. At the six month followup, gains obtained by the treatments were maintained. Turk's study suggested
that a comprehensive outpatient treatment program is effective in reducing
symptoms of FMS. An interdisciplinary program conducted by Bennett et al
considered group-oriented treatments 4 . This study included patient education,
behavior modification, stress reduction, physical fitness, and flexibility. The
FIQ, the VAS pain, tender point score, QOLS, and the Coping Strategies
Questionnaire (CSQ) were used for measurements. After a long term follow up
of two years, 33 patients in the treatment program continued to show
improvement, while the 29 non-treatment control group showed no significant
improvement. A review conducted by Rossy et al compared 49 treatment
studies and concluded that non-pharmacological treatments with an emphasis
on exercise and cognitive-behavioral therapy, in conjunction with management
of medications for sleep and pain, is the optimal intervention for FMS 41 .
28
Alternative, non-traditional medicines are often used concurrently with
traditional western approaches. Tabers Cyclopedic Medical Dictionary defines
alternative medicine as "approaches to medical diagnosis and therapy that have
not been developed by use of generally accepted scientific methods" 48 .
Patients with FMS seek out alternative medicine when traditional approaches
provide little or no relief of symptoms 21 . Examples include chiropractic
treatments, acupuncture, Watsu, Shiatsu, massage, homeopathic medicine,
herbal medicine, and various dietary strategies 21 . Mind-body therapies include
biofeedback, relaxation , meditation, hypnosis, imagery, yoga, and t'ai' chi2 1 .
Aquatic therapy has been used as early as 440 BC by Hippocrates. He
advocated the use of water for all ailments involving muscle and joint
complaints 22 . The Romans adopted this practice and expended enormous
amounts of effort building elaborate spas. Throughout history cultures have
continued the use of warm therapeutic baths. During the world wars, soaking in
water was a common treatment for soldiers22 . Today researchers continue to
explore the effects of aquatic therapy on the physical, mental and social
aspects of the body.
Levin et al reported that aquatic therapy offered benefits for a wide
spectrum of patients ranging in functional abilities 30 • For example, Levin et al
contended patients with illnesses who cannot tolerate land exercises due to the
effects of gravity on muscles and joints, athletes recovering from injury, as well
as patients with arthritis and spinal chord injuries, can benefit from aquatic
therapy 30 . According to several studies, the goals of aquatic therapy are:
29
1) reduce pain and inflammation, 2) increase range of motion, flexibility and
strength, 3) increase endurance, and 4) improve overall health and wellbeing22.3o,3a,42.
Haralson, codirector of the Arthritis Foundation YMCA Aquatic Program,
confirmed the beneficial anecdotal effects of aquatic therapy for arthritic
patients 3. Haralson stated that "the water has a soothing effect on joints, giving
these patients some relief' 3. Patients attested to experiencing less gravitational
pull on joints, relieved pain and increased freedom of movement3. With
increased movement, patients reported better joint mobility, increased flexibility
and cardiovascular fitness, which they could not achieve on land 3.
Symptoms of FMS are exacerbated by weight bearing exercises47 .
Aquatic therapy provides an avenue for patients with FMS to exercise without
the adverse effects of impact30 . Archimedes' principle states: "when a body is
wholly or partially immersed in fluid, it experiences an upthrust equai to the
weight of the fluid displacement" 13 . This "upthrust" is called buoyancy, and it is
this phenomenon that is involved in reducing the compression forces of
3
gravity 1 . The effect of buoyancy on the body results in a reduction of energy
expended for weight bearing 13 . Additional research on the effects of buoyancy
was carried out by Harrison et al 23 . This study revealed the reduction of weight
bearing that occurred at different depths of body immersion. Results of the
study indicated 1) a reduced weight bearing of 40% - 56% of total body mass
when immersed to the level of the anterior superior i!iac spine, 2) a reduced
weight bearing status between 50% to 75% of total body mass when
30
submerged to clavicle level, and 3) when submerged above the clavicle it
resulted in "almost complete loss of weight bearing"23 . The above percentages
were determined during static standing. McNeil et al and Ruoti et al purported
that Archimedes' principle resulted in decreased joint compression, muscle
activity, and enhanced relaxation of muscle groups
34 42
· .
Patients with FMS typically are caught in a cycle of pain and fatigue,
leading to deconditioning 47 . Aerobic exercise in water is indicated for patients
with FMS in order to break this cycle and improve overall health 47 . Ruoti et al
conducted a study to determine the effects of non-swimming water exercises on
older adults42 . The water exercise group experienced a reduced resting heart
rate, a 15% increase in V02max and work capacity. The non-exercising control
group did not improve on any variables measured. Ruoti et al, like the McNeil
study, reported that the advantages of water exercise are attributed to the
effects of buoyancy. McNeil et al suggested these effects reduced joint stress in
lower limbs, while simultaneously using the resistance of the water to expend
calories and increase cardiovascular activity. This study suggested
implementing water exercise treatments for individuals with injury or muscular
diseases 34 .
A study by Hall et al evaluated the effects of aquatic therapy on 139
subjects with chronic Rheumatoid Arthritis (RA). Subjects were randomly
assigned to either a seated immersion in water, land exercise, progressive
relaxation, or a water exercise group. An analysis of physical and psychological
factors was conducted before and after treatments and at a three month follow
31
up. Hall et al hypothesized that "the combined effects of warm water immersion
and exercise in water are therapeutically superior to either used singly" 22 .
Measurements were taken by the Ritchie Articular Index to assess joint
tenderness, the McGill Pain Questionnaire to assess quantitative and qualitative
aspects of pain, the Believes and Pain Control Questionnaire (BPCQ), and the
Arthritis Impact Measurement Scale II (AIMS II). All the tests were found to be
reliable and valid, with the exception of the MPQ 22 . Results of physical
variables from the Ritchie Index showed the "exercise in water" group had the
most significant amount of improvement (p<0.002) resulting in decreased joint
tenderness and increased knee ROM (p<0.049) at post-test among the three
groups. All patients experienced a significant reduction in pain, as well as an
increase in the belief in control of pain at post-test. Health status measured by
AIMS II revealed all patients significantly improved physical capacity at post-test
and follow-up. Significant improvements in mood and tension with patients in
the water exercise group again demonstrated the greatest improvement
compared to the other three groups. Further analysis revealed women received
greater improvement then men 22 .
The "Twinges in The Hinges" Aquatic Program
In 1974, the "Twinges in The Hinges" program was developed by Kit
Wilson 3 . This program has grown in popularity over the years for patients
diagnosed with RA, Osteoarthritis (OA), FMS and other rheumatologic
32
diseases 3 . Two highly recognized organizations, The Arthritis Foundation and
the Young Men's Christian Association (YMCA), met and formed a task force in
19833 . This task force was comprised of staff and volunteers from both of these
organizations, who reviewed and endorsed the existing program. The result of
this meeting led to new guidelines, procedures, identification of teaching
methods, as well as the renaming of the "Twinges in The Hinges" to "The
Arthritis Foundation YMCA Aquatic Program (AFYAP)". It was reported in
December of 1995 that 100% of all Arthritis Foundation chapters were offering
AFYAP classes. At that time, 84,430 participants were involved in this
recreational aquatic program 3 .
The AFYAP focuses on exercises which increase range of motion,
strength, and conditioning. Participants partake in this program to decrease
pain and preserve or improve joint mobility. The emphasis is on slow, correct
movements rather than speed and number of repetitions. With this program,
the patients are taught the importance of pacing themselves in all activities.
The exercises are carried out within a social group setting led by an instructor
who oversees the safety, correct implementation of the exercises and proper
sequencing. Buoyancy, warm water, specific low-impact exercises, and
stretching make this aquatic recreational program ideal for patients with FMS.
AFYAP is recommended one to two times per week and for a class
length of 30 to 60 minutes depending on the severity of arthritis and level of
tolerance 3 . Classes include a five minute warm up, an exercise portion, and a
five minute cool down period. New classes and/or new participants should
33
begin with three repetitions and gradually increase to 15. The exercises are
executed with the patients moving submerged body parts. The instructor does
not physically assist participants at any time. The rule of thumb is if a patient's
pain persists over two hours after the session, the patient should reduce the
number of repetitions for the following session. If pain, however, continues after
decreased repetitions, the patient should consult his/her physician 3 .
The contraindication for this aquatic program suggested by the Arthritis
Foundation is recent surgery. Some of the exercises may exacerbate
symptoms, therefore, it is recommended that each participant review the
exercises of AFYAP with his/her physician, therapist or surgeon before
continuing 3 . Precautions for aquatic therapy include fever, cardiac failure,
severe urinary tract infection, intermittent bowel and bladder incontinence, and
open wounds 17 .
This program is commonly used nationwide in facilities such as the
YMCA, hospitals, rehabilitation and recreational facilities. Physicians continue
to endorse this program by referring their patients to local AFYAP programs.
Extensive search failed to reveal any documentation involving scientific
data on the effects of the 'Twinges in the Hinges" program on any rheumatic
disease. The purpose of this research is to explore the effects of the 'Twinges
in the Hinges" aquatic program on patients diagnosed with FMS.
34
Assessment
For the purpose of this study, several instruments which measure the
severity and/or changes associated with symptoms of FMS, including pain,
unrestful sleep, stiffness, self-efficacy, anxiety and functional level in daily
activities were examined . Visual analog scales and self-adm inistered
questionnaires were found to be used repeatedly in the studies reviewed.
Based on further review of the literature, the following tools were found to be
appropriate for this study.
Visual analog sca les (VAS): research conducted by Price et al found
VAS a reliab le and valid tool for the assessment of intensity and affect
(perceived unpleasantness) of pain 37 . Patients rated their chronic pain levels
on a VAS analog scale, then were given electric pain impulses to their forearms
and asked to adjust the pain level to match the level of their chronic pain. The
correlation between pain levels was high (r=0.97). The study found that VAS
can accurately predict pain intensity and affect along ratio scales, allowing the
use of a wide range of statistical tools. Another tool that has been found useful
for the measurement of pain is the McGill Pain Questionnaire 8 . However, the
ease of use and time efficiency of a one-line VAS when compared to the McGill
Pain Questionnaire's several page assessment, may enhance patient
cooperation .
35
Finckh et al investigated the validity of self-reported questionnaires, and
found them to be valid response criteria for treatment efficacy in short term
clinical trial in patients with FMS 18 . Patients in this study completed three selfreport questionnaires, which were then compared to clinical assessments.
Correlations ranged from r=0.53 to r=0 .61. Portney et al, in a book entitled
"Foundations of Clinical Research," pointed out there is a potential for bias and
inaccuracy using self-report questionnaires, since the researcher does not
directly observe the respondent's behavior or attitudes, but only records the
respondent's report of them 40 . However, Portney et al stated : "For many
psychological variables such as perceptions, fears, motivations, and attitudes,
there is no more direct way to obtain information"40 . Questionnaires are widely
used to assess symptoms and functional coping. Questionnaires have the
advantage of measuring the patients' subjective self-evaluation over a period of
time, i.e. during the week following or preceding treatment, as opposed to
physical tests and clinical evaluations, which can only make assessments at a
specific point in time.
For the purpose of this research, a self-administered questionnaire was
chosen: the 20 question Fibromyalgia Impact Questionnaire (Appendix A). The
FIQ contains three parts: part one evaluates patients' perceptions of how often
they were able to perform common tasks such as house and yard work, driving,
stair climbing and shopping, on a scale from "always" to "never" . Part two
addresses days missed from work and number of days the patients felt good .
Part three contains seven additional questions regarding pain, sleep, stiffness,
36
anxiety, nervousness and depression, which are graded on a VAS. The FIQ
was developed in response to the need for a tool geared to assess the major
characteristics and functional limitations specific to FMS. The reliability and
31
validity of the FIQ have been established in several studies 4 · 10 ·12 •
.
Burckhardt
et al conducted a study on 89 women diagnosed with FMS 10 . Subjects
completed the Arthritis Impact Measurement Scale (AIMS), the FIQ and the
Health Assessment Questionnaire (HAQ.) The study found the FIQ to be
reliable (correlations for each item of the FIQ ranged from r=0.56 to r=0:95)
and valid (r=0.67) when compared to the AIMS, which is already known to be
reliable and valid in rheumatic disease subgroups. The FIQ was tested in a
Hebrew version as well and shown to be reliable ( r=0.80 to 0.96) and valid
(p<0.01, with an r-value of 0.30 to 0.83) 12 . Mannerkorpi et al studied a ten-year
literature search comparing several measures and instruments used to assess
functional limitations and disability in patients with FMS 31 . This study examined
the HAQ, the AIMS, the FIQ, the Sickness Impact Profile (SIP), the ASES, the
Coping Strategies Questionnaire, the Hassles scale, the Quality of Life Scale
(QOLS) and the Rheumatology/ Fibromyalgia Attitude Index (RAI/FAI).
Mannerkorpi et al found that the HAQ discriminated between patients with mild
or severe disability. However, the HAQ was designed for the assessment of
disability in RA patients and might not cover the disability particular to FMS.
Mannerkorpi et al found no studies designed to assess the reliability or validity
of the HAQ for the FMS population ; nor were there any studies assessing the
sensitivity of the HAQ.
Mannerkorpi et al stated "the only instrument designed
37
and extensively validated for the FMS population is the FIQ." Although the
AIMS was a valid tool to assess symptoms and functional limitations in patients
with RA, the questions addressing dexterity and household subscales were
found to have little value for assessing disability in FMS. Bennett et al
evaluated the impact of a 6 month group therapy program on the treatment of
patients with FMS 4 . Bennett et al commented on the internal consistency in
outcome measures between the Quality of Life Scale, the VAS for pain, the
control of pain index, the tender point count and the FIQ, providing validity to
the use of such tools in the evaluation of patients with FMS . Bennett et al found
the FIQ score to be "the most sensitive" measure of outcome variables. The
FIQ was selected for the purpose of this study because it is an easy to use,
self-report questionnaire which has been proven valid and reliable and
specifically addresses the symptoms and functional limitations unique to FMS.
METHODS AND MATERIALS
Subjects
A sample of convenience consisting of a minimum of 20 adult female
volunteers who have a confirmed diagnoses of FMS will be studied. Subjects
will be solicited from Arthritis Foundation Self-Help meetings, FMS support
groups, Arthritis Foundation Newsletters, public radio announcements,
physicians and other health professional referrals.
38
A screening questionnaire of each individual's current health status will be
used to determine eligibility of potential subjects (Appendix B). Inclusion
qualifications for participation in this study include the following:
1. Individuals must have been diagnosed with FMS by a physician according to
the American College of Rheumatology (ACR) guidelines (Appendix C) .
2. Subjects must be female, age 21 or older.
3. Participants must be willing to participate in a group setting, adhere to safety
procedures and follow the correct sequence of exercises set forth by the
instructor.
4. Participants must be able to ambulate with or without the use of an assistive
device.
5. Subjects will need to read and sign two documents, "Rights of Human
Subjects in Medical Experiments" (Appendix D) and a subject consent form
(Appendix E). Two copies of each form will be distributed to the subjects to
be filled out before the first session . One copy will be given to the individual
and the other copy will remain on file with the research team.
6. Individuals must be able to read and understand English .
Exclusion criteria for participants include:
1. Open wounds.
2. Unstable and/or uncontrolled medical conditions, including incontinence.
3. Widespread osteoarthritis.
4. Susceptibility to ear infections.
5. Participation in an aquatic exercise program currently or within the previous
39
three months.
6. Initiation or participation of any land exercise program within the last month.
7. Subjective self-report of pain less than 4/10 on a 10 point scale.
Procedures
The tool used will be the FIQ (Appendix A). The SPSS a is the statistical
software that will be used
cm an IBM compatible computer for statistical
analysis.
The independent variable for this study will be the "Twinges in the
Hinges" aquatic exercise program. The dependent variables will include the
three components of the FIQ: part one evaluates patients' perceptions of how
often they were able to perform common tasks; part two addresses days
missed from work and number of days the patients felt good, and part three
contains seven additional questions regarding pain, sleep, stiffness, anxiety,
nervousness and depression. The study will use a multi-factorial repeat
measure design.
The subjects (2n=10, total 20) will be randomly assigned to either Group
A, or Group 8. There will be four six week periods for each group:
•
Period one: Group A will complete the FIQ for six consecutive Saturdays.
•
Period two: Group A will begin the six week "Twinges in the Hinges"
asPSS for Windows, Advanced Statistic Release 6.0 SPSS Inc. Ch icago.IL.
40
•
program, while completing the FIQ 15 minutes before the first treatment and
ten minutes after each of the six treatments. Group B will complete the FIQ
for six consecutive Saturdays.
•
Period three: Group A will be required to refrain from participation in any
exercise program, while maintaining normal activities. Group A will continue
to complete the FIQ at one, three and six weeks post-treatment. Group B
will begin the six week "Twinges in the Hinges" program, while completing
the FIQ 15 minutes before the first treatment and ten minutes after each of
the six treatments.
•
Period four: Group B will be required to refrain from participation in any
exercise program, while maintaining normal activities. Group B will continue
to complete the FIQ at one, three and six weeks post-treatment.
Structuring the periods in this manner will ensure that each group will receive
equal amounts of contact with the researchers. By the use of a crossover
design, each group will act as a control group as well a treatment group.
Each 'Twinges in the Hinges" aquatic exercise session will include a five
minute warm-up period, a 25 to 30 minute exercise interval, and a five minute
cool down period. These 45 minute sessions will be taught once a week, for a
total of six weeks. The five minute warm-up and cool-down period will include
four exercises. A record of specific exercises used during each session will be
recorded .
The exercise portion will pmgress from two to three repetitions up to a
maximum of fifteen, based on the needs of the group as the instructor deems
41
appropriate. The instructor will not touch the participants during the exercises
in order to avoid injury by exceeding the subjects' pain free range of motion.
Subjects will be reminded to pace themselves and are told to stop if any
exercise hurts. The philosophy of "listen to your body" will be emphasized.
The exercises will emphasize underwater movement. The sequence and
general categories of the exercises are as follows:
1. Walking exercises.
2. Breathing and chest expansion exercises.
3.
Neck exercises.
4. Trunk stretching exercises.
5.
Shoulder exercises.
6. Elbow exercises.
7. Wrist and finger exercises.
8. Hip and knee exercises.
9. Ankle and toe exercises.
10. Lower extremity exercises.
For each of the above exercise categories there are a variety of specific
exercises which the instructor will chose from. A typical lesson plan is
presented in Appendix F.
The treatments will be carried out in an indoor pool at St. Francis Medical
Center, Santa Barbara, California. There will be no cost for participation.
Subjects wil! have access to dressing rooms, showers and towels. Subjects will
be able to enter and exit the pool by use of stairs and handrails to provide safety
42
and ease of maneuvering. The water temperature will range from 87 - 89
degrees Fahrenheit and the air temperature will be within 5 degrees of water
temperature. The depth of the pool ranges from three to six feet. This depth will
allow the individuals' shoulders to be submerged as they exercise. A bathing
suit will be the only attire required for this program. Earplugs will be allowed. If
the participant cannot hear what the instructor is saying, the subject will be
positioned closer to the instructor.
There will be one Physical Therapist and one assistant during each
exercise session in the pool area. Both will be trained in the "Twinges in the
Hinges" program . The assistant will be certified in CPR, first aide, and the
United States Coaching Swim and Safety Training. The instructor will be leading
the class from within the water, while the assistant will assist participants on
land, oversee the treatment, and demonstrate exercises.
Data Analysis
A repeat measures ANOVA analysis will be used on all dependent
variables. Analysis of demographic and screening data will be carried out by
descriptive statistical measures. A significance level of p<0.05 will be used for
all statistical tests.
43
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48
Appendix A
FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)
Directions: For questions 1 through 1t, please circle the number that best describes how you
did overall for the past week. If you don't normally do something that is asked, cross the
question out.
Always
OccasionaUy
Most
Were you able to:
1 . Do shoppingt ...........................................0
Never
2
3
2.
Do laundry with a washer and dryer? ....... 0
1
2
3
3.
Prepare meals?.......................... .............. 0
1
2
3
4.
Wash dishes/cooking utensils by hand? ... 0
2
3
5.
Vacuum a rug? ...................•......................0
2
3
6.
Make bedsl ................................ ..... ......... 0
2
3
7.
Walk several blocks? ................................ 0
2
3
8.
Visit friends or relativesL ......................... O
2
3
9.
Do yard woncl ......................... ................. 0
2
3
2
3
2
3
1
10. Drive a cart ............................................ 0
1
11. Climb stairs? ............................................. 0
12. Of the 7 days in the past week, how many days did you feel good?
0
1
2
3
4
5
7
6
13. How many days last week did you miss work, including housework, because of
fibromyalgial
0
1
2
3
4
5
continued on back of page
49
6
7
ABROMYALGIA IMPACT QUESTIONNAIRE (FtQ)
Directions: For the remaining items, mari< the point on the line that best indicates how you
felt overall for the past week.
t 4. When you worked, how much did pain or other symptoms of your fibromyalgia interfere
with your ability to do your work, including housewori<?
•
I
I
I
I
I
I
I
.e
Great difficulty
with work
No problem
with wori<
15. How bad has your pain been?
•
I
I
•
I
No
Very severe
pain
pain
16. How tired have you been?
•
I
•
I
No
Very
tiredness
tired
17. How have you felt when you get up in the morning?
•
I
I
I
•
I
Awoke
well rested
Awoke
very tired
1 6. How bad has your stiffness been?
•
I
I
•
I
t~o
Very
stiff
stiffness
19. How nervous or anxious have you felt?
e
I
I
I
•
I
Not
anxious
Very
anxious
20. How depressed or blue have you feltl
e
I
I
I
•
I
Not
Very
depressed
depressed
50
Appendix B
Screening Questionnaire for Study of Effects of "Twinges in the Hinges" on
Fibromyalgia.
1.
Gender: F M
Age: 21-29
30-39
40-49
50-59
60-69
70-79
80+
2.
Dr. diagnosed FMS: Yes
No_ _
Tender points: Yes
No_ _
Non-restorative sleep: Yes
No_ _
Morning stiffness: Yes
No_ _
Anxiety: Yes
No_ _
Headaches: Yes
No- Depression: Yes
No_ _
3.
Estimated time from the first onset of symptoms: _ _ _ _ _ _ _ __
4.
Pain medications:
5.
Do you work outside the home? Yes _ _
6.
Are you currently receiving any therapy for FMS? Yes
Hours I week:
No_ _
7.
Have you participated in aquatic therapy before? Yes
If Yes, please state when _ _ _ _ __
No_ _
8.
Are you currently active in an exercise program? Yes
If Yes, for how long , and what type?
No_ _
9.
Do you have a history of:
Unstable or uncontrolled medical condition Yes
Widespread osteoarthritis Yes
No
- - - - - - - - - - - - - - - - ---~
No- -
--
No
--
10.
How would you rate your current level of pain of a scale of 1-1O?
1,2,3 - painful, but able to be fully functioning.
4,5,6 - limits ability to perform some functions.
7,8,9 - unable to function without assistance.
10
- need immediate attention.
11 .
Are you currently experiencing acute symptoms? Yes
12.
Do you have problems with ear infections, or ears being in water?
Yes
No
--
51
No_ _
This study will require participation in the "Twinges in the Hinges" program
once a week for 6 weeks, and 6 weeks of non-participation. Missed days would
eliminate you from the study. Are you available? Yes
No_ _
Please be aware there is no cost for your participation .
Thank you.
52
Appendix C
Fibromyalgia Study
Diagnosis Verification Form
Note to the Doctor:
A study being conducted as part of California State University Northridge
Physical Therapy Master's Thesis, supported by St. Francis Medical Center,
Santa Barbara, California, is examining the effects of the "Twinges in the
Hinges", a warm water recreational exercise program, on individuals with FMS.
"Twinges in the Hinges" is a recreational series of gentle activities carried out in
a warm pool. The program is designed to help relieve the pain and stiffness
caused by arthritis. In addition, this program may offer increased range of
motion, strength and conditioning. Increase in flexibility and improved joint
mobility may also be gained. Social interactions within a group setting may
offer enjoyment during exercise, thus encouraging attendance. It is not
necessary to know how to swim. Instructors are trained to conduct the
sessions.
The sessions will be held on Saturdays from noon to 12:45 p.m. at St. Francis
Medical Centers' therapeutic pool. Sessions will meet once weekly and run for
six weeks.
Persons participating in the study will be asked to complete the Fibromyalgia
Impact Questionnaire (FIQ) for six weeks before the study starts, immediately
after all sessions, and at one, three, and six weeks after the last session. Your
patient;
, has indicated an interest in
participating in this study. Due to the warm water, 96 degree Fahrenheit, and
the gentle exercises involved, all potential participants are advised to seek
consultation from their doctor about whether they can safely participate in this
program. Prior to participation, we are requesting documentation that your
patient has an appropriate diagnosis. Please fill out the enclosed form and
return it to your patient so she can return it to us.
If you have any questions about this study, please contact Nancy Rogers at
(805) 563-0421, or e-mail OneDulaney@aol.com .
Thank you for your cooperation.
Nancy Rogers
Heidi Whitney
53
Renata Decher
Diagnosis Verification Form
Part I: For Patient to Complete
I give permission to Dr. ____________ to complete this
Diagnosis Verification Form
Your Signature
Date
Part II: For Physician to Complete
My patient, named above, has been diagnosed with Fibromyalgia Syndrome, as
defined by the American College of Rheumatology 1990 Guidelines.
Physician's Signature
Date
Please print or stamp ~ddress here:
54
Appendix D
RIGHTS OF HUMAN SUBJECTS IN MEDICAL EXPERIMENTS
A person who is requested to consent to participate as a subject in a research
study involving a medical experiment or who is requested to consent on behalf
of another, has the right to:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Be informed of the nature and purpose of the experiment.
Be given an explanation of the procedures to be followed in the medical
experiment, and any drug device to be utilized.
Be given a description of any attendant discomforts and risks reasonably
to be expected from the experiment.
Be given an explanation of any benefits to the subject reasonably to be
expected from this experiment, if applicable.
Be given a disclosure of any appropriate alternative procedures, drugs or
devices that might be advantageous to the subject, and their relative
risks and benefits.
Be informed of the avenue of medical treatment, if any available, to the
subject after the experiment if complications should arise.
Be given an opportunity to ask any questions concerning the experiment
or the procedures involved.
Be instructed that consent to participate in the medical experiment may
be withdrawn at any time and the subject may discontinue participation in
the medical experiment without prejudice.
Be given a copy of any signed and dated written consent form used in
relation to the experiment.
Be given the opportunity to decide to consent or not to consent to a
medical experiment without the intervention of any element of force,
fraud, deceit, duress, coercion, or undue influence on the subject's
decision.
Subject's Signature
Date
Witness
Date
55
Appendix E
SUBJECT CONSENT FORM
Project title: The Effect of the "Twinges in the Hinges" recreational aquatic
program on patients with Fibromyalgia Syndrome (FMS).
Number of subjects: 20
Investigators: Nancy Rogers, Heidi Whitney, Renata Decher, Master of Physical
Therapy students, Department of Health Sciences, Californic3 State University
Northridge (CSUN).
Committee: Diana J. Osterhues, DPT, OCS, Chair, CSUN faculty; Steven F.
Loy, Ph.D., CSUN faculty; Sue Mintz, PT, clinician at St. Francis Medical
Center, Santa Barbara, California
University Address:
California State University, Northridge
Department of Health Sciences
c/o Physical Therapy Department
Northridge, CA 91330-8285
Rehabilitation Pool Address:
St. Francis Medical Center
601 E. Micheltorena Street
Santa Barbara, CA 93103
Subject's Name_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Date_ __
The purpose of this study is to explore the effects of the "Twinges in tile Hinges"
aquatic recreational program on pain and functional abilities in patients
diagnosed with FMS.
The study will be conducted at St. Francis Medical Center aquatic therapy pool
in Santa Barbara, California. You will be asked to wear a bathing suit, or
appropriate swim wear. You will be asked to fill out a questionnaire for six
weeks before, during, and six week after the exercise program. Each session
lasts 45 minutes.
The "Twinges in the Hinges" program may provide benefits including increased
range of motion, strength and conditioning. You also may experience a
decrease in pain, improved joint mobility, and enjoy the social benefits of
exercising within a group setting. Risks may include muscle soreness.
You will be informed of any changes in the nature of this study or in the
procedures, as described above, as they occur. You may leave the study any
time. You may or may not receive any benefit from this study. The benefit of
the study to humanity is evidence concerning the efficacy of the "Twinges in the
Hinges" as an aquatic recreational program for individuals diagnosed with FMS.
56
In the event that physical injury arising from participation in this investigation
requires care, you will be financially responsible for this care. In the event of an
emergency, by signing this form, you give permission for the trained staff to
administer any form of First Aide or CPR to sustain life until professional help
can be obtained. If additional medical attention is required, you will use your
customary health resources.
You will take full responsibility for your voluntary participation in this study and
agree to in no way hold St. Francis Medical Center or any of its employees
responsible or liable for injury or any physical condition that may result from
your participation.
The results of this research may be published and used for educational
purposes and to inform physicians, clinicians, and scientists. Confidentiality will
be maintained and only be disclosed with your written permission, or if required
by law.
A committee of medical and non-medical professionals periodically will review
and approve this research for scientific and ethical merit. You will be told of any
new information which will effect your willingness to continue this research.
Your refusal to participate in the project will in no way involve penalty or loss of
benefits to which you are otherwise entitled. Your participation is strictly
voluntary. You may withdraw from the research project any time. If you have
any questions now or later, please ask the researchers . You will be given a
copy of this form to keep. If at any time you feel an infringement of your rights,
you may contact Sue Mintz, BS, PT at St. Francis Medica l Center, for answers
to your questions about the research and your rights.
I volunteer for this study of my own free will and realize that I may withdraw at
any time without question. I acknowledge that I have fully reviewed and
understand the contents of the consent form. I have been given a copy of the
Signed Consent form and the Experimental Subjects Bill of Rights.
Subjects signature - - - - - - - - - - - - -
Date- - - - - - -
Witness
Date- - - - - - -
----------------~
57
I certify that I have reviewed the contents of this form with the person signing
above, who, in my opinion understood the explanation. I have explained the
known side effects and benefits of the research.
Investigator's signature _ _ _ _ _ _ _ _ _ __
58
Date - - - - - - -
Appendix F
Following is a typical lesson plan.
Breathing
arms overhead
hands behind
Neck
look over shoulder
head to shoulder
Trunk
side bending
twist
hip roll
Shoulders
pinch and curl shoulder blades
shoulder shrugs
shoulder circles
raise bent elbows overhead
arms to shoulder level, turn palms up and down
move hands up spine
breaststroke arms
hug yourself
pat your shoulders
Elbows
thumbs to shoulder
fingers to shoulder
Wrist and Fingers
arms in front, palms supinate and pronate
wrists flex and extend
prayer position
thumb circles
alternate touching thumb to each finger
Hip and Knees
leg swings
bend and straighten knee
bend knee and swing thigh
leg pendulum
leg circles
shift weight
single leg stretch
double leg stretch
59
Ankles and Toes
toes up and down
foot circles
foot inward - outward
point foot
Lower Extremity and Abdominal Exercises
knees to chest
bicycle
scissors
Warm Down
easy walking
focus breathing
60