[
]
research report
EMILIO J. PUENTEDURA, PT, DPT1 • MERRILL R. LANDERS, PT, DPT2 • JOSHUA A. CLELAND, PT, PhD3
PAUL MINTKEN, PT, DPT4 • PETER HUIJBREGTS, PT, DPT5 • CESAR FERNANDEZ-DE-LAS-PEÑAS, PT, DO, PhD6
Thoracic Spine Thrust Manipulation
Versus Cervical Spine Thrust Manipulation
in Patients With Acute Neck Pain:
A Randomized Clinical Trial
TTSTUDY DESIGN: Randomized clinical trial.
TTOBJECTIVE: To determine if patients who met
the clinical prediction rule (CPR) criteria for the
success of thoracic spine thrust joint manipulation
(TJM) for the treatment of neck pain would have
a different outcome if they were treated with a
cervical spine TJM.
TTBACKGROUND: A CPR had been proposed to
identify patients with neck pain who would likely
respond favorably to thoracic spine TJM. Research
on validation of that CPR had not been completed when this trial was initiated. In our clinical
experience, though many patients with neck pain
responded favorably to thoracic spine TJM, they
often reported that their symptomatic cervical
spine area had not been adequately addressed.
TTMETHODS: Twenty-four consecutive patients,
who presented to physical therapy with a primary
complaint of neck pain and met 4 out of 6 of the
CPR criteria for thoracic TJM, were randomly
assigned to 1 of 2 treatment groups. The thoracic
group received thoracic TJM and a cervical rangeof-motion (ROM) exercise for the first 2 sessions,
followed by a standardized exercise program for an
additional 3 sessions. The cervical group received
cervical TJM and the same cervical ROM exercise for
the first 2 sessions, and the same exercise program
given to the thoracic group for the next 3 sessions.
Outcome measures collected at 1 week, 4 weeks,
and 6 months from start of treatment included the
Neck Disability Index, numeric pain rating scale, and
Fear-Avoidance Beliefs Questionnaire.
TTRESULTS: Patients who received cervical TJM
demonstrated greater improvements in Neck
Disability Index (P.001) and numeric pain rating
scale (P.003) scores at all follow-up times. There
was also a statistically significant improvement in
the Fear-Avoidance Beliefs Questionnaire physical
activity subscale score at all follow-up times for
the cervical group (P.004). The number needed
to treat to avoid an unsuccessful overall outcome
was 1.8 at 1 week, 1.6 at 4 weeks, and 1.6 at 6
months.
TTCONCLUSION: Patients with neck pain who met
4 of 6 of the CPR criteria for successful treatment
of neck pain with a thoracic spine TJM demonstrated a more favorable response when the TJM
was directed to the cervical spine rather than the
thoracic spine. Patients receiving cervical TJM also
demonstrated fewer transient side-effects.
TTLEVEL OF EVIDENCE: Therapy, level 1b. J Orthop
Sports Phys Ther 2011;41(4):208-220, Epub 18
February 2011. doi:10.2519/jospt.2011.3640
TTKEY WORDS: clinical prediction rule, manual
therapy, mobilization, prognosis
N
eck pain is a common
complaint within the
general
population,
and one that over 50%
of individuals report having
experienced at some point in
their lives. 3,4 While
12-month prevalence
rates for neck pain SUPPLEMENTAL
VIDEO ONLINE
are estimated to be
between 30% and 50%, disabling neck
pain is less common, with estimated
12-month prevalence rates of 2% to 11%.22
Individuals with significant neck pain often have considerable disability, resulting
in substantial economic hardship. Neck
pain is most often managed conservatively and frequently by referral to physical
therapy.27 Physical therapists commonly
approach the clinical management of
patients with neck pain by incorporating
manual therapy interventions directed to
the cervical spine. These manual therapy
techniques include passive joint mobili-
Assistant Professor, Department of Physical Therapy, School of Allied Health Sciences, University of Nevada Las Vegas, Las Vegas, NV. 2Associate Professor, Department of
Physical Therapy, School of Allied Health Sciences, University of Nevada Las Vegas, Las Vegas, NV. 3Professor, Department of Physical Therapy, Franklin Pierce University,
Concord, NH. 4Assistant Professor, Department of Physical Therapy, School of Medicine, University of Colorado, Aurora, CO. 5In memoriam, Assistant Professor, University
of St Augustine for Health Sciences, St Augustine, Florida; Clinical Consultant, Shelbourne Physiotherapy Clinic, Victoria, British Columbia, Canada. 6Professor, Department
of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain. This clinical trial received full board
approval from The University of Nevada Las Vegas, Office for the Protection of Human Research Subjects. Address correspondence to Dr Emilio J. Puentedura, Assistant
Professor, University of Nevada Las Vegas, School of Allied Health Sciences, Department of Physical Therapy, 4505 Maryland Parkway, Box 453029, Las Vegas, NV, 89154-3029.
E-mail: louie.puentedura@unlv.edu
1
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zation (nonthrust techniques) and thrust
joint manipulation (TJM).
Although there is solid evidence to
support manual therapy directed at
the cervical spine in patients with neck
pain,5-7,10,23,30 physical therapists may be
reluctant to apply TJM to the cervical
spine because of perceived risks associated with thrust techniques applied to this
region.1,8,17,28 Recent research has shown
that TJM directed to the thoracic spine
provides a therapeutic benefit to some
patients with neck pain13 and has been
suggested as an appropriate strategy to
minimize the risks associated with manipulation of the cervical spine. Despite
this, cervical spine TJM continues to be
provided to patients with neck pain30 and
is recommended in patients with cervicogenic headache.7
In their derivation study, Cleland et
al12 developed a clinical prediction rule
(CPR) to identify a subgroup of patients
with neck pain who were more likely to
benefit from thoracic spine TJM. In that
study, the researchers treated all patients
with thoracic spine TJM and a general
range-of-motion (ROM) exercise and using a logistic regression model, identified
the common characteristics (prognostic
variables) of patients who met the criteria
for treatment success. These prognostic
variables were used to define the CPR;
however, more recent evidence has questioned its validity.15
A regional interdependence approach
to the treatment of patients with neck
pain is gaining support both clinically and
in published research reports.2,39,41,42,45
While treatment of the thoracic spine in
these patients has demonstrated benefits
and involves arguably less risk, it may not
completely address the symptoms and
mobility impairments with which these
patients present. It has been our experience that adding cervical manipulation to
a comprehensive management approach
improves clinical outcomes. The purpose
of this randomized clinical trial was to
determine the differences in outcome
using cervical spine TJM compared to
thoracic spine TJM to treat patients with
neck pain who met the criteria for the
CPR.
METHODS
Participants
C
onsecutive patients with a primary complaint of neck pain, who
presented to physical therapy between December 2008 and April 2010,
were screened for eligibility. To be eligible to participate, patients had to be
between 18 and 60 years of age, have
a primary report of neck pain with or
without unilateral upper extremity
symptoms, and have a baseline Neck Disability Index (NDI) score of 10/50 points
or greater. Additional inclusion and exclusion criteria for this trial were based
on those used by Cleland et al12 in their
CPR derivation study. Finally, patients
had to satisfy at least 4 out of the following 6 criteria: symptom duration less
than 30 days, no symptoms distal to the
shoulder, no aggravation of symptoms
by looking up, Fear-Avoidance Beliefs
Questionnaire Physical Activity (FABQPA) subscale score of less than 12, decreased upper thoracic spine kyphosis
(T3-T5), and cervical extension range of
motion (ROM) less than 30°.
Exclusion criteria included any serious pathology (such as neoplasm), a
diagnosis of cervical spinal stenosis (as
identified in the patients’ medical intake form) or bilateral upper extremity
symptoms, evidence of central nervous
system involvement, 2 or more positive
neurologic signs consistent with nerve
root compression (changes in sensation,
myotomal weakness, or decreased deep
tendon reflexes), pending legal action
regarding their neck pain, a history of
whiplash injury within 6 weeks of the
examination, or any history of cervical spine surgery, rheumatoid arthritis,
osteoporosis, osteopenia, or ankylosing
spondylitis. The study was approved by
the University of Nevada Las Vegas Biomedical Institutional Review Board. All
individuals provided informed consent
prior to their participation.
INTERVENTIONS
Examination
P
rior to randomization, all patients underwent a standardized
history and physical examination.
Demographic information collected included age, sex, mechanism of injury (if
any), location and nature of symptoms,
and the number of days since onset of
symptoms. The historical examination
included follow-up questions regarding
aggravating and relieving factors, 24hour behavior of presenting symptoms,
and any prior history of neck pain.
The physical examination followed
the same protocol as that described by
Cleland et al,12 beginning with a neurological screen,18 followed by postural assessment.29 Cervical ROM was measured
and symptom response assessed, followed by assessments of muscle length
and strength. The amount of motion
and symptom response were recorded
for segmental passive intervertebral mobility testing18 of the cervical spine and
passive accessory intervertebral mobility
testing32 of the cervical and thoracic spine
(C2-T9).
The physical examination was then
concluded with a number of special tests
typically performed in the examination of
patients with neck pain, including Spurling’s test,38 the neck distraction test,44 and
the median neurodynamic test (MNT). 35
Patients were also screened for any signs
of vertebrobasilar insufficiency (VBI),
such as nystagmus, gait disturbances,
and Horner’s syndrome, as well as screening for upper cervical spine ligamentous
laxity through the Sharp-Purser test, alar
ligament stress test, and transverse ligament tests.11 Patients who had a positive
finding on any of these final screening
tests were excluded from the study.
Outcome Measures
All patients completed several commonly
used instruments to assess pain and perceived disability. The Neck Disability
Index (NDI) is the most widely used condition-specific disability scale for patients
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[
with neck pain,15 and consists of 10 items
addressing different aspects of function,
each scored from 0 to 5, with a maximum possible score of 50 points.40 The
NDI has been reported to be a reliable
and valid outcome measure for patients
with neck pain.21,36,40,46 In a recent systematic review of the literature, MacDermid et al31 concluded that the minimal
detectable change (MDC) for the NDI is
5 points out of 50, whereas 7 points out
of 50 was recommended for the minimal
clinically important difference (MCID).
To measure pain intensity, we used
an 11-point numeric pain rating scale
(NPRS),25,26,34 ranging from 0 (“no pain”)
to 10 (“worst imaginable pain”). Patients
were asked to rate their current level of
pain, and their worst and least amount
of pain in the preceding 24 hours, and
the 3 ratings were averaged to represent
the patient’s level of pain. The MDC and
MCID for the NPRS have been reported
as 2.1 and 1.3 points, respectively.14
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a 16-item questionnaire
designed to quantify fear and avoidance
beliefs in patients with low back pain.43,47
The FABQ has 2 subscales: a 4-item
scale to measure fear-avoidance beliefs
about physical activity (FABQ-PA) and
a 7-item scale to measure fear-avoidance
beliefs about work (FABQ-W). Each item
of the FABQ-PA and FABQ-W is scored
from 0 to 6, with possible scores on the
FABQ-PA raging from 0 to 24 and on the
FABQ-W from 0 to 42, and higher scores
representing increased fear-avoidance
beliefs. As in previous studies, the FABQ
was modified by replacing the word
“back” with the word “neck.”12,15 Currently, there are few published estimates for
the MDC and MCID of the FABQ. Grotle et al20 reported an MDC of 12 points
for the physical activity subscale (FABQPA) and 9 points for the work subscale
(FABQ-W); however, these were for the
Norwegian version.
Finally, starting at the second treatment session and at each follow-up period, patients completed the 15-point
global rating of change (GROC) scale
research report
]
FIGURE 2. Supine upper thoracic on midthoracic
spine thrust manipulation in cervicothoracic
flexion used in this study. The therapist used his
manipulative hand to stabilize the inferior vertebra
of the motion segment targeted and used his body to
push down through the patient’s arms, to perform a
high-velocity, low-amplitude thrust.
FIGURE 1. Seated thoracic spine distraction thrust
manipulation used in this study. The therapist placed
his upper chest at the level of the patient’s middle
thoracic spine and grasped the patient’s elbows. A
high-velocity distraction thrust was performed in an
upward direction.
described by Jaeschke et al.24 The scale
ranges from –7 (“a very great deal worse”)
to 0 (“about the same”) to +7 (“a very
great deal better”). It has been reported
that scores of +4 and +5 are indicative of
moderate changes in patient-perceived
status and scores of +6 and +7 indicate
large changes in patient status.24 As
in studies that have developed and attempted to validate the CPR,12,15 patients
who rated their perceived recovery on
the GROC as “a very great deal better,” “a
great deal better,” or “quite a bit better”
(a score of +5 or greater) at any followup treatment session were considered
to have experienced dramatic improvements. The MCID for the GROC has
been reported as a 3-point change from
baseline.24
Randomization
One of 3 physical therapists recruited
patients who met the eligibility criteria
and collected all baseline demographics
and self-report variables. The 3 physical
therapists, who were blinded to group allocation, collected all outcome measures
during the trial. Patients were randomly
allocated to 1 of the 2 treatment groups
by drawing index cards showing the
group assignment from sealed, opaque
envelopes. A researcher with over 30
years of clinical experience in TJM and
blinded to the outcome measures performed all of the treatment interventions.
It was not possible to blind the patients
and the treating researcher to treatment
allocation because of the nature of the
interventions. Patients and the treating
researcher were instructed not to reveal
treatment allocation to the clinicians who
were collecting the outcome measures.
Treatment Procedures
Once all examination procedures were
complete, patients were randomly assigned to 1 of 2 groups: (1) patients who
received thoracic TJM and an exercise
program (thoracic group) or (2) patients
who received cervical TJM and an exercise program (cervical group). The exercise program was standardized for both
groups and is described in detail in the
APPENDIX. Both groups attended physical therapy sessions 3 times during the
first week and 2 times during the second week, for a total of 5 sessions over a
2-week period.
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FIGURE 3. Supine middle to lower thoracic spine
thrust manipulation used in this study. The therapist
used his manipulative hand to stabilize the inferior
vertebra of the motion segment targeted and used
his body to push down through the patient’s arms to
perform a high-velocity, low-amplitude thrust.
Thoracic TJM Group During the first 2
sessions, patients in the thoracic group
received thoracic TJM and a cervical
ROM exercise. The cervical ROM exercise was the 3-finger exercise for cervical
rotation, as originally described by Richard Erhard16 (APPENDIX), which was performed in the clinic as well as at home.
All patients in this group received 3 different thoracic spine TJM techniques
that were identical to those used in the
CPR derivation study.12 A maximum of 2
attempts for each TJM technique was allowed, regardless of having achieved joint
cavitation. According to the model for
describing thrust manipulations recently
proposed by Mintken et al,33 the following techniques were used:
1. A high-velocity, midrange, distraction force to the midthoracic spine
on the lower thoracic spine in a sitting position. The therapist placed
his upper chest at the level of the
patient’s middle thoracic spine
and grasped the patient’s elbows. A
high-velocity distraction thrust was
performed in an upward direction
(FIGURE 1 and ONLINE VIDEO).
2. A high-velocity, end range, anteriorposterior force applied through the
elbows to the upper thoracic spine
on the midthoracic spine in cervicothoracic flexion. This technique
was performed with the patient po-
FIGURE 4. Cervical spine thrust manipulation used
in this study. The therapist used his manipulative
hand to localize the motion segment targeted and
used both hands to perform a high-velocity, lowamplitude thrust into rotation, which was directed up
towards the patient’s contralateral eye.
sitioned supine. The therapist used
his manipulating hand to stabilize
the inferior vertebra of the motion
segment targeted and his body to
push down through the patient’s
arms, to perform a high-velocity,
low-amplitude thrust (FIGURE 2 and
ONLINE VIDEO).
3. A high-velocity, end range, anteriorposterior force applied through the
elbows to the middle thoracic spine
on the lower thoracic spine in cervicothoracic flexion. This technique
was performed with the patient positioned supine. The therapist used
his manipulating hand to stabilize
the inferior vertebra of the motion
segment targeted and his body to
push down through the patient’s
arms, to perform a high-velocity,
low-amplitude thrust (FIGURE 3 and
ONLINE VIDEO).
During the last 3 therapy sessions,
patients did not receive further TJM
and, instead, performed a standardized
therapeutic exercise program. Patients
continued performing the 3-finger cervical rotation exercise and also commenced
a new set of exercises, as described below
and illustrated in the APPENDIX. All exercises were performed in a comfortable,
seated position, for 3 sets of 10 repetitions each, in the clinic. Patients were instructed to perform these exercises 3 to 4
times per day, within pain tolerance, each
day during participation in the study.
These exercises were as follows:
1. Three-finger exercise for cervical
rotation16
2. Bilateral shoulder shrugs and scapular retractions (against gravity only)
3. Bilateral shoulder horizontal adduction and abduction, with hands
clasped behind the head
4. Upper cervical flexion and extension, with hands clasped behind
the head and elbows held together
(keeping elbows stationary and
moving the head into forearms)
5. Lower cervical flexion and extension, with hands clasped behind
the head and elbows held together
(keeping upper cervical spine stationary and moving elbows up towards ceiling and into lap)
6. Thera-Band rows, with moderateresistance elastic band (green)
7. Lateral pull-downs, with moderateresistance theraband (green)
Cervical TJM Group During the first 2
sessions, patients in the cervical group received cervical TJM and performed the
same 3-finger cervical ROM exercise as
the thoracic group (APPENDIX). All patients
in the cervical group received the same
cervical spine TJM technique applied
to both sides of the neck. The treating
therapist, based on pain localization and
detection of perceived joint hypomobility,
used his clinical discretion to choose the
most appropriate or symptomatic cervical motion segments and attempted to
localize the TJM to those levels. A maximum of 2 attempts for each side of the
cervical spine was allowed, regardless of
having achieved joint cavitation. Using
the model for describing thrust manipulations recently proposed by Mintken et
al33 to, in this example, target the C4-5
level on the left, we used a high-velocity,
midrange, right rotational force to the left
articular pillar of C4, on the left articular
pillar of C5, in supine, with right rotation
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[
TABLE 1
research report
Baseline Demographic and Self-Report
Variables for All Patients in Both Treatment Groups*
Variable
Thoracic Group (n = 10)
Cervical Group (n = 14)
P Value
Age (y)
33.1  5.8
34.1  7.0
.723†
6 (60%)
10 (71%)
.673‡
18.8  9.3
11.7  7.0
.044†
5 (50%)
9 (64%)
.760§
Cervical extension ROM (°)
21.5  6.4
26.8  7.1
.067†
FABQ-PA (0-24)
8.0  4.0
9.7  4.1
.316†
FABQ-W (0-42)
3.4  2.6
5.2  2.8
.121†
Sex (female)
Symptom duration (d)
Pain location (unilateral)
Abbreviations: FABQ-PA, Fear-Avoidance Beliefs Questionnaire physical activity subscale; FABQ-W,
Fear-Avoidance Beliefs Questionnaire work subscale; ROM, range of motion.
*Values are mean  SD and n (%).
†
Independent t test.
‡
Fisher exact test.
§
Pearson chi-square.
and left sidebending. This technique was
performed with the patient positioned
supine. The therapist used his manipulating hand to localize the targeted C4-5
motion segment and both hands to perform a high-velocity, low-amplitude
thrust, directed up towards the patient’s
contralateral eye (FIGURE 4 and ONLINE VIDEO).19 During the last 3 therapy sessions,
patients in the cervical group performed
the same standardized therapeutic exercise program as that described previously
for the thoracic group.
Follow-up
All patients completed the GROC and
NPRS prior to the start of each subsequent treatment session. Patients were
also asked for the presence of any posttreatment side effects (increased neck
pain, headache, dizziness, etc) after treatment sessions 1 and 2, which included the
TJM interventions. Formal follow-up
assessments were performed at 1 week
(prior to treatment on the fourth visit), 4
weeks, and 6 months. At each follow-up
assessment, patients completed the NDI,
NPRS, GROC, and FABQ.
Data Analysis
Key baseline demographic variables and
scores on the self-report measures were
compared between groups, using inde-
pendent t tests for continuous data and
chi-square tests of independence for
categorical data (TABLE 1). The primary
aim (effects of treatment on disability
and pain) was examined with a 2-way
repeated-measures analysis of variance (ANOVA), with treatment group
(thoracic thrust versus cervical thrust
manipulation) as the between-subjects
variable and time (baseline and follow-up
periods) as the within-subjects variable.
Separate ANOVAs were performed with
disability (NDI) and pain (NPRS) as the
dependent variable. For each ANOVA,
the hypothesis of interest was the 2-way
(group-by-time) interaction. Interactions
were analyzed by using simple main effects for the between-group differences
at each measurement point, with a Bonferroni-corrected alpha of .0125 (4 independent-samples t tests). In addition,
GROC data for the cervical and thoracic
groups were compared using a Wilcoxon
rank sum test for each of the following
time points: posttreatment 1, 1 week, 4
weeks, and 6 months. Data were analyzed using 2 different approaches. First,
an intention-to-treat (ITT) analysis was
performed for all patients originally randomized in the trial. Missing data points
for dropouts were imputed using the lastobservation-carried-forward method. We
also analyzed only the data of those who
]
completed the trial, which is referred to
as the per-protocol analysis. Data analysis was performed using PASW Statistics
18 (IBM, Somers, NY).
To determine absolute risk reduction (ARR) and number needed to treat
(NNT), an outcome was deemed an
overall success if all of the following occurred: NDI score improvement met or
exceeded MDC and MCID (7 scale points
out of 50), NPRS score improvement met
or exceeded MDC and MCID (2.1 scale
points), and GROC score was at least a
+5. If a patient did not meet all 3 of the
aforementioned criteria, the outcome
was deemed unsuccessful. In addition,
ARR and NNT were calculated for patients who at the 6-month time point required further treatment and continued
medication use for their neck pain following the study intervention. The need for
further treatment and/or medication was
also defined as an unsuccessful outcome.
RESULTS
N
inety-six consecutive patients
with a primary complaint of neck
pain were screened for possible eligibility. The reasons for ineligibility can
be found in FIGURE 5, the flow diagram of
patient recruitment and retention. Of the
96 patients screened, 24 patients (mean
 SD age, 33.7  6.4 years; range, 26-48
years; 67% female) satisfied the eligibility criteria and agreed to participate in
the study. Ten patients were randomly
assigned to receive thoracic TJM and
exercise, and 14 patients were randomly assigned to receive cervical TJM and
exercise. The baseline demographic and
self-report variables for both treatment
groups are shown in TABLE 1. Four patients in the cervical TJM group did not
complete all 5 treatment sessions, citing
complete relief (full recovery) of their
symptoms. Of these 4 patients, 2 completed the GROC and NPRS at the start
of the second session but did not want to
continue treatment. The other 2 patients
completed the GROC and NPRS at the
start of third session but also declined
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further treatment and follow-up. For all 4
of these patients, we did not obtain NDI
or FABQ beyond baseline scores.
Patients screened for
eligibility (n = 96)
Not eligible (n = 72):
• Did not meet CPR
(n = 56)
• Whiplash (n = 8)
• Red flags (n = 5)
• Prior surgery (n = 2)
• Cervical stenosis (n = 1)
Neck Disability
In the ITT analysis, there was a significant group-by-time interaction on the
NDI (F3,66 = 7.241; P = .011; ηp2 = .248;
Greenhouse-Geisser correction secondary to a violation of sphericity, P<.001)
(FIGURE 6). Using a Bonferroni-corrected
alpha (.0125), we found no differences
between the cervical and thoracic manipulation groups at baseline (P = .482),
1 week (P = .028), and 4 weeks (P = .021);
however, there was a significant difference at 6 months (P = .004) (TABLE 2). In
the ITT analysis, 10 out of 14 patients
in the cervical group demonstrated improved scores that met or exceeded the
MDC and MCID for the NDI from baseline to 4 weeks and from baseline to 6
months; for the thoracic group, 1 patient
improved to meet or exceed the MDC and
MCID at both time points.
In the per-protocol analysis there was
also a significant group-by-time interaction on the NDI (F3,54 = 40.260; P<.001;
ηp2 = .691; Greenhouse-Geisser correction secondary to a violation of sphericity,
P<.001). At baseline, there was no difference between the 2 groups (P = .482).
However, at all follow-up points the cervical group had significantly lower NDI
scores than the thoracic group (P.001).
Neck Pain
The ITT analysis showed a significant
group-by-time interaction on the NPRS
(F3,66 = 15.506; P<.001; ηp2 = .413; Greenhouse-Geisser correction secondary to a
violation of sphericity, P<.001). Using a
Bonferroni-corrected alpha of .0125, we
found no significant differences between
the cervical and thoracic manipulation
groups at baseline (P = .213); however, we
did find significant differences between
the 2 groups at 1 week (P = .003), 4 weeks
(P<.001), and 6 months (P<.001) (FIGURE
7). The ITT analysis showed that 12 out
of 14 patients in the cervical manipulation group had improved scores that
Randomized (n = 24)
Thoracic spine TJM
(n = 10)
Cervical spine TJM
(n = 14)
1-wk follow-up
(n = 10)
1-wk follow-up
(n = 10)
4-wk follow-up
(n = 10)
4-wk follow-up
(n = 10)
6-mo follow-up
(n = 10)
6-mo follow-up
(n = 10)
Did not want to
continue, “felt
100%” (n = 4)
FIGURE 5. Flow diagram of patient recruitment and retention. Abbreviations: CPR, clinical prediction rule; TJM,
thrust joint manipulation.
met or exceeded the MDC and MCID
for the NPRS at both the 4-week and
6-month points. In the thoracic manipulation group, 4 (at 4 weeks) and 2 (at 6
months) out of 10 patients had improved
scores that met or exceeded the MDC and
MCID. The results of the per-protocol
analysis were identical to those of the
ITT analysis. TABLE 2 shows the disability
and pain scores for both groups at each
follow-up period.
Fear-Avoidance Beliefs
The ITT analysis also showed a significant group-by-time interaction for the
FABQ-PA (F3,66 = 4.271; P = .045; ηp2 =
.163; Greenhouse-Geisser correction
secondary to a violation of sphericity,
P<.001). There were no differences between the cervical and thoracic groups
prior to treatment (P = .316). Nor were
there differences at the 1-week (P = .082),
4-week (P = .242), and 6-month (P =
.037) measurement points (TABLE 2). The
per-protocol analysis provided results
that were different. A significant groupby-time interaction was observed (F3,54 =
17.503; P<.001; ηp2 = .493; GreenhouseGeisser correction secondary to a violation of sphericity, P<.001). Again, there
was no difference between the cervical
and thoracic groups prior to treatment (P
= .316). There were, however, statistically
significant differences at each of the subsequent measurement points, all favoring
the cervical group (P.004) (FIGURE 8).
Global Rating of Change
After 1 treatment, the median (range)
GROC for the patients in the cervical
manipulation group (+6 [+4 to +7]) was
significantly better than that of the tho-
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racic manipulation group (+2 [0 to +4])
(W = 56.00, z = –4.083, P<.001). After 1
week, the median (range) GROC for the
patients in the thoracic manipulation
group (+4 [+1 to +6]) was higher but still
significantly lower than that of the patients in the cervical manipulation group
(+7 [+7 to +7]) (W = 55.00, z = –4.595,
P<.001). The GROC of the patients in the
cervical manipulation group continued
to be significantly higher than that of the
thoracic manipulation group at both the
4-week (W = 55.00, z = –4.620, P<.001)
and 6-month (W = 55.00, z = –4.588,
P<.001) measurement points. All patients in the cervical manipulation group
reported a GROC of +7 at 4 weeks and 6
months; however, in the thoracic manipulation group the medians (ranges) for
the GROC were still lower at 4 weeks (+4
[+1 to +6]) and 6 months (+3 [+1 to +5]).
research report
]
16
14
P = .482
P = .028
12
P = .004
P = .021
10
NDI (0-50)
[
8
6
4
2
0
Baseline
1 wk
4 wk
Thoracic
6 mo
Cervical
FIGURE 6. Mean Neck Disability Index (NDI) score, with 95% CI for the intention-to-treat analysis over the course
of the trial for the cervical and thoracic manipulation groups.
NNT Analysis
Treatment Side Effects
The ARR ratio for an unsuccessful outcome (those not meeting all 3 of the
success criteria at the end of treatment)
from baseline to week 1, when taking into
account the 4 patients who were lost to
follow-up, was 57.1% (95% CI: 29.2%,
85.1%). The associated NNT was found to
be 1.8 (95% CI: 1.2, 3.4) in favor of the cervical thrust manipulation group. The ARR
ratio for an unsuccessful outcome (those
who did not meet all 3 of the success criteria at the end of the trial) at 4 weeks,
when taking into account the 4 patients
who were lost to follow-up, was 61.4%
(95% CI: 31.3%, 91.5%). The associated
NNT was 1.6 (95% CI: 1.1, 3.2) in favor of
the cervical manipulation group as well.
The ARR and NNT for the outcome at 6
months were the same as those at 4 weeks.
The ARR ratio for an unsuccessful
outcome at 6 months (those needing
medication or further treatment after
the trial), taking into account the 4 patients lost to follow-up, was 50.0% (95%
CI: 15.5%, 84.5%). The NNT to avoid this
unsuccessful outcome was 2.0 (95% CI:
1.2, 6.5). See TABLE 3 for overall treatment
outcomes for the cervical and thoracic
manipulation groups.
Patients reported no adverse events during the treatment period, nor were any
identified during the 6-month follow-up.
We defined an adverse event as sequelae
medium- to long-term in duration, with
moderate to severe symptoms that were
serious, distressing, and unacceptable to
the patient and required further treatment.9 Some patients did report minor
side effects, which were defined as short
term, mild in nature, nonserious, transient, and were reversible consequences
of the treatment, such as an increase in
neck pain, headache, and fatigue.37 These
posttreatment side effects were reported
to disappear within 24 to 48 hours. In
the per-protocol analysis, which had no
data for posttreatment side effects of the
4 patients who dropped out of the study,
only 1 patient in the cervical group (7%)
reported a minor posttreatment side effect (increased neck pain) after the first
treatment, and none reported side effects
after the second treatment. Conversely, 8
patients in the thoracic group (80%) reported minor posttreatment side effects
after the first treatment, and 7 patients in
the thoracic group (70%) reported minor
side effects after the second treatment.
These minor posttreatment symptoms
were reported as increased neck pain, fatigue, headache, or upper back pain that
resolved within 24 hours of onset.
DISCUSSION
T
he results of this study show
that patients with mechanical neck
pain who fit the CPR for thoracic
spine thrust manipulation may demonstrate better overall outcomes with TJM
directed to the cervical spine as opposed
to the thoracic spine. Patients in the cervical group, compared to the thoracic
group, showed significantly greater improvements on all of the outcome measures. In addition, patients in the cervical
TJM group experienced fewer transient
posttreatment side effects.
Ten out of 14 patients in the cervical
group achieved improvements in the NDI
that met or exceeded the MDC and MCID
from baseline to 4 weeks and from baseline to 6 months, whereas only 1 patient
in the thoracic group met or exceeded
the MDC and MCID at these follow-up
points. The cervical group also experienced more rapid and greater pain relief
than the thoracic group. Twelve of the 14
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6
P = .213
5
NPRS (0-10)
4
3
P = .003
P<.001
P<.001
2
1
0
–1
Baseline
1 wk
4 wk
Thoracic
6 mo
Cervical
FIGURE 7. Mean numeric pain rating scale (NPRS) score, with 95% CI for the intention-to-treat analysis over the
course of the trial for the cervical and thoracic manipulation groups.
12
P = .316
10
P<.004
FABQ-PA (0-24)
8
P<.004
6
P<.004
4
2
0
Baseline
1 wk
4 wk
Thoracic
6 mo
Cervical
FIGURE 8. Mean Fear-Avoidance Beliefs Questionnaire physical activity subscale (FABQ-PA) score with 95% CI for
the per-protocol analysis over the course of the trial for the cervical and thoracic manipulation groups.
patients in the cervical group achieved
improvements in the NPRS that met or
exceeded the MDC and MCID, and all the
patients in the cervical group achieved
GROC equal to or greater than +5 within 1 week. In contrast, only 3 of the 10
patients in the thoracic group achieved
improvement in the NPRS that met or
exceeded the MDC and MCID, and only
2 out of 10 reported a GROC score equal
to or greater than +5 within 1 week.
The majority of patients in the cervical
group, compared to only 1 thoracic patient in the thoracic group, met the criteria for overall success at both the 4-week
and 6-month follow-ups. The NNT of
1.8 in favor of the cervical group over the
thoracic group suggests that only 2 patients with neck pain would need to be
treated with cervical TJM to prevent an
unsuccessful outcome at 1 week. Similarly, an NNT of 1.6 in favor of the cervical
group at 4 weeks and 6 months suggests
that only 2 patients with neck pain would
need to be treated with cervical TJM to
prevent an unsuccessful outcome at those
time points.
Only 1 patient in the cervical group
reported a need for further treatment
and medication at the 6-month followup, whereas, in the thoracic group, 8
patients required further treatment and
7 required continued medications. The
NNT to avoid the need for further treatment and medication was 2.0 in favor of
cervical manipulation, so that only 2 patients with neck pain would need to be
treated with cervical TJM to prevent the
need for further treatment and medication for 1 patient at 6 months.
While the sample size in our study was
small, we feel that it was sufficient to produce meaningful statistics. Furthermore,
the 4 patients lost during the study were
actually those demonstrating the best
and most immediate response. Thus, our
results might have underestimated the
true differences.
Thoracic spine manipulation has
been shown to be advantageous for patients with neck pain,13 and a CPR had
been derived12 to identify those patients
who would most likely benefit from such
treatment. This CPR was recently examined for validity in a randomized clinical
trial,15 the results of which did not support the CPR’s validity. However, the
authors did demonstrate that patients
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[
]
research report
Outcomes From the Intention-to-Treat Analysis for Both Groups at Each Follow-up Period*
TABLE 2
Outcome/Group
Baseline
1 wk
4 wk
6 mo
NDI (0-50)
Thoracic
12.6  1.9 (10.9, 14.3)
10.9  2.0 (9.0, 12.8)
9.1  3.7 (6.0, 12.2)
9.9  3.9 (6.6, 13.2)
Cervical
13.4  2.9 (11.9, 14.8)
8.3  3.4 (6.7, 9.9)
4.2  5.4 (1.6, 6.8)
3.7  5.7 (0.9, 6.5)
NPRS (0-10)
Thoracic
3.6  1.4 (2.4, 4.9)
2.1  1.6 (1.5, 2.8)
1.9  1.0 (1.5, 2.3)
2.3  1.1 (1.9, 2.8)
Cervical
4.6  2.2 (3.6, 5.7)
0.1  0.2 (–0.5, 0.7)
0.1  0.1 (–0.3, 0.4)
0.1  0.1 (–0.3, 0.4)
FABQ-PA (0-24)
Thoracic
8.0  4.0 (5.4, 10.6)
5.5  3.6 (3.3, 7.7)
4.0  2.7 (1.9, 6.1)
5.2  3.0 (3.0, 7.4)
Cervical
9.7  4.1 (7.5, 12.0)
2.9  3.3 (1.0, 4.8)
2.4  3.4 (0.7, 4.2)
2.1  3.5 (0.3, 4.0)
Abbreviations: FABQ-PA, Fear-Avoidance Beliefs Questionnaire physical activity subscale; NDI, Neck Disability Index; NPRS, numeric pain rating scale.
*Values are mean  SD (95% CI).
TABLE 3
Overall Treatment Outcomes From the Intention-to-Treat Analyses for the Cervical and Thoracic Manipulation Groups
Outcome
Baseline to 1 wk
Baseline to 4 wk
Baseline to 6 mo
Cervical TJM
NDI, met or exceeded MDC and MCID
8/14
10/14
10/14
NPRS, met or exceeded MDC and MCID
12/14
12/14
12/14
GROC, at least +5
14/14
14/14
14/14
Overall success (met all 3 above criteria)
8/14
10/14
10/14
...
...
Treatment, 1/10*; medication, 1/10*
Unsuccessful outcome, need for further treatment or medication
Thoracic TJM
NDI, met or exceeded MDC and MCID
0/10
1/10
1/10
NPRS, met or exceeded MDC and MCID
3/10
4/10
2/10
GROC, at least +5
2/10
2/10
2/10
Overall success (met all 3 above criteria)
0/10
1/10
1/10
...
...
Treatment, 8/10; medication, 7/10
Unsuccessful outcome (need for further treatment or medication)
Abbreviations: GROC, global rating of change scale; MCID, minimal clinically important difference; MDC, minimal detectable change; NDI, Neck Disability
Index; NPRS, numeric pain rating scale; TJM, thrust joint manipulation.
*No data about need for further treatment or medication were available for the 4 patients who dropped from the study.
with mechanical neck pain who received
thoracic spine TJM and exercise, compared to patients who received exercise
only, exhibited significantly greater improvements in pain and disability. These
results suggest that the CPR did not help
to identify patients with mechanical neck
pain who would demonstrate greater improvements when provided with thoracic
spine TJM in addition to exercise. They
did, however, show that patients with
mechanical neck pain (and no contraindications for TJM), who were given a
combination of thoracic spine TJM and
exercise, had statistically and clinically
significant greater improvements in pain
and disability compared to those who received exercise alone. One limitation suggested by the authors of this study was
that different exercise approaches might
have resulted in different outcomes.
In the recent CPR validation study,15
patients who were positive on the CPR
and received thoracic manipulation had
a baseline mean NDI of 14.0/50, which
improved to 6.3/50 at 1 week, 4.1/50 at
4 weeks, and 3.2/50 at 6 months. Patients in the thoracic group of our study
had a comparable mean NDI score at
baseline (12.6/50) but did not show as
much improvement over time (10.9/50
at 1 week, 9.1/50 at 4 weeks, and 9.9/50
at 6 months). A comparison of changes
in NPRS measures between the thoracic
manipulation groups in the 2 studies
revealed a similar trend: patients in the
CPR validation study15 had a NPRS score
of 4.3 at baseline, 1.9 at 1 week, 1.6 at 4
weeks, and 1.5 at 6 months; patients in
the current study started with a lower
mean NPRS score at baseline (3.6) and
did not appear to improve as much over
time, with mean scores of 2.1 at 1 week,
1.9 at 4 weeks, and 2.3 at 6 months. The
inconsistencies in outcomes between
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these studies might be explained by their
different exercise programs. Patients in
the validation study15 participated in a
more extensive program, which included
manual stretching by the physical therapist, whereas the current study limited
its exercise program to those exercises
described in the APPENDIX.
It is also important to note that the
patients in the current study presented
with acute neck pain. Mean duration of
symptoms for all patients was 14.7 days,
and the duration of symptoms for those
in the cervical group (11.7 days) was
shorter (P = .044) than that of the thoracic group (18.8 days). This is a limitation associated with the randomization
in the study and may account for some
of the differences observed in outcomes
between groups. The shorter the duration of the patients’ symptoms in this
study contrasts with that of the patients
in the CPR derivation and validation
studies.12,15 In the CPR derivation study,12
mean duration of symptoms was 80 days
for all patients, 54.6 days for those who
experienced a successful outcome, and
109.6 days for the nonsuccessful outcome
group. In the CPR validation study,15 the
mean duration of symptoms was 63.5
days for all patients, regardless of their
status on the CPR, 53.0 days for those patients who were classified as positive on
the CPR (the manipulation group), and
47.6 days for the exercise-only group.
It is possible that a shorter duration
of symptoms may be associated with better outcomes of manual therapy to the
cervical spine. In a recent study, Leaver
et al30 compared cervical spine TJM with
nonthrust mobilization techniques in patients with recent-onset neck pain. The
authors tracked days to recovery from
neck pain, defined as the first of 7 consecutive days on which the patient reported
less than 1 on a 0-to-10 NPRS. While they
found no difference in recovery rates, less
than 60% of patients in both the manipulation and mobilization groups actually
achieved recovery.30 They also found no
better outcomes between the groups in
terms of pain, disability, function, global
perceived effect, or health-related quality of life.30 The mean  SD duration of
symptoms for all patients in that study
was 19.4  20.0 days,30 indicating that
not all patients had a symptom duration
of less than 30 days. Also, the baseline
characteristics of these patients showed
that 63.2% reported a previous episode
of neck pain and a majority had concomitant symptoms such as upper limb
pain (79.1%), headache (64.3%), and
upper back pain (63.2%).30 These findings suggest that very few of the patients
in that study would have met the inclusion criteria for our current study and,
furthermore, 30.8% reported dizziness/
vertigo and 22.5% reported nausea,
which would have excluded them from
our study. Despite the absence of adverse
events related to the cervical manipulation treatment and an equal prevalence
of minor side effects such as additional
neck pain and headache for both the manipulation and mobilization groups, the
authors suggested that practitioners and
their patients reevaluate the use of manipulation for recent-onset neck pain. 30
The short duration of symptoms in
our study sample might have been due
to our choosing a cutoff point of 4 out of
6 predictor variables for a positive status
on the thoracic TJM CPR. The CPR validation study15 used 3 out of 6 predictors
to determine status on the rule, based on
the derivation study’s12 finding of a wide
CI for the positive likelihood ratio (LR)
associated with positive findings on 4 out
of 6 tests (95% CI: 2.28, 70.8). By choosing the more stringent cutoff, our study
sample was limited to patients with a
symptom duration of less than 30 days,
as prospective patients who did not meet
this particular criterion invariably had
difficulty meeting at least 3 out of the
remaining 5 predictor variables. All patients in our study had a symptom duration of equal to or less than 30 days and
had no symptoms distal to the shoulder.
Study Limitations
Several important limitations of this
study should be noted, the first of which
is its small sample size. Despite screening
close to 100 potential patients, we were
only able to recruit about 25% into the
study because of the stringent inclusion
and exclusion criteria used in the CPR
derivation study. Considering the study’s
small sample size, we chose to be conservative with our statistical analyses and
used a Bonferroni correction. Despite
this approach, our results demonstrated
significant differences between groups
on all outcome measures at most of the
follow-up points, with the exception of
the NDI changes at the 1-week (P = .028)
and 4-week (P = .021) follow-ups. Had we
not used the Bonferroni correction, these
NDI changes would have been significant (P<.05). Unfortunately, we did not
examine the outcomes in patients who
had neck pain regardless of their status
on the rule, which could be an area for
future research.
Patients in the cervical group had significantly shorter duration of symptoms
compared to those in the thoracic group.
This occurred despite adequate randomization and may well have been due to our
relatively small sample size. Another limitation is that all patients were recruited
from 1 of 2 clinics in a city (Las Vegas)
within the Western United States, and all
interventions were provided by 1 practitioner. Future studies should recruit a
larger sample size from more diverse locations and involve a greater number of
practitioners to better generalize the results. Also, as with other trials involving
manual therapy interventions, it was not
possible to blind the practitioner or patients to treatment allocation, as in some
placebo-controlled trials.
CONCLUSION
T
his study tested 2 different
forms of TJM in a select group
of patients with mechanical neck
pain who met a previously derived12 and
recently questioned CPR.15 We found
that patients who were treated with a
combination of cervical spine TJM and
exercises showed significantly greater
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[
improvement in pain and disability compared to those treated with thoracic spine
TJM and exercises. Our results suggest
that patients with neck pain of less than
30 days in duration, who meet 4 out of
the 6 CPR criteria for thoracic spine TJM,
may benefit more from cervical than thoracic spine TJM. t
KEY POINTS
FINDINGS: Patients who were treated
with a combination of cervical spine
TJM and exercises showed significantly
greater improvement in pain and disability compared to those treated with
thoracic spine TJM and exercises. They
also experienced fewer transient posttreatment side effects than patients who
had thoracic spine manipulation and
exercise.
IMPLICATION: The CPR for thoracic spine
manipulation and exercise in patients
with neck pain may actually be helpful
in identifying patients who are more
likely to benefit from cervical spine manipulation, but this needs to be formally
tested.
CAUTION: Several factors limiting the
generalizability of this study include a
small sample size, that all patients had
acute neck pain (neck pain for less than
30 days), and that all interventions were
provided by 1 physical therapist.
ACKNOWLEDGEMENTS: It is with great sadness
that we say good-bye to our close friend and
colleague Peter Huijbregts, who tragically
passed away on November 6, 2010. Peter made
many terrific contributions to the profession of
physical therapy and has been instrumental
in the battle to maintain manipulation within
the scope of our practice. Peter had a terrific
passion for life and was truly an inspiring
individual who will be greatly missed by us
and the profession.
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APPENDIX
THE EXERCISE PROGRAM PERFORMED BY BOTH TREATMENT GROUPS DURING THE TRIAL*
Following the thrust joint manipulation at each of the first 2 treatment sessions, both groups performed the 3-finger exercise for cervical rotation, as originally
described by Richard Erhard.16
For the third through to fifth treatment sessions, both groups performed the therapeutic exercises, as shown below.
1. B
ilateral shoulder shrugs and scapular retractions (against gravity
only)
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APPENDIX
2. B
ilateral shoulder horizontal adduction and abduction with hands
clasped behind the head
3. U
pper cervical flexion and extension with hands clasped behind the
head and elbows held together (keeping elbows stationary and moving
the head into forearms)
4. L ower cervical flexion/extension, with hands clasped behind the head
and elbows held together (keeping upper cervical spine stationary and
moving elbows up towards ceiling and into lap)
5. Thera-Band rows with moderate-resistance elastic band (green)
6. Lateral pull-downs with moderate-resistance elastic band (green)
*Images used with permission from International Spine & Pain Institute.
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