PREGNANCY-RELATED LOW BACK PAIN
AND THE EFFICACY OF CAM INTERVENTION:
A PILOT RANDOMIZED CONTROLLED TRIAL
Caroline Peterson, DC, PhD, MPH, CPM
Mitch Haas, DC, MA
W. Thomas Gregory, MD
PREGNANCY-RELATED LOW BACK PAIN
EPIDEMIOLOGY
 Insidious
onset during pregnancy
 > 50% all pregnancies1,2
 Intensity and frequency increases3
 Only consistent predictor: Hx LBP
 68% LBP unreported1
 25% of those reporting LBP are treated1
 2/3 require sick leave due to LBP4
 1/3 untreated LBP continues 1 year
postpartum1,5,6 at increased risk of
comorbidities7
PILOT RANDOMIZED CONTROLLED TRIAL

Participants
Healthy 20-49 years old
 Pregnant with singleton
 LBP of insidious onset during pregnancy


Comparison groups
Exercise
 Spinal manipulation
 Neuro-emotional technique

Enter study at any point in pregnancy
 Study visits parallel prenatal visits

SAMPLE CHARACTERISTICS (N=57)
MEAN OR FREQUENCY
29.7 years old (5.0 SD), range 20-40
 77% White non-Hispanic
 66% at least 4 year college degree
 72% married
 77% work outside home during pregnancy

3 times pregnant (1.9 SD), range 1-9
 1 times given birth (1.1 SD), 0-5


25.4 wks entered study (6.4 SD), range 10-37
SAMPLE HISTORY OF LOW BACK PAIN
MEAN OR FREQUENCY
54% history of low back pain prior to pregnancy
 25.4 weeks gestation LBP began, range 2-28
 12.3% taking medication for LBP at study start
 25% took time off work due to LBP

27.9 BMI at study entry, range 21-35
 93% health very or quite good prior to pregnancy
 61% at least weekly exercise prior to pregnancy


Location LBP: Lumbosacral (50.9%), Pelvis
(21%), Lumbar (14%), Composite (10.5%)
SPECIFIC AIM #1
Determine the Feasibility of the Study
 Can 90 pregnant women be recruited within
12 months?
 Can participants comply with exercise
expectation and treatment schedule?
 Can a completion rate of 90% be achieved?
 What is the average cost per participant?
 Does a qualitative component to the study
further explain PRLBP?
CAN 90 PREGNANT WOMEN BE RECRUITED
WITHIN 12 MONTHS?
Assessed for eligibility n=138
 Excluded n=81
 Randomized n=57
 Discontinued prior to 37 weeks n=12

Exercise n=7 (32%)
 NET n=2 (10%)
 SMT n=3 (20%)


Sample analyzed n=57
Exercise n=22 (n=16, 2+ data points)
 NET n=20 (n=19, 2+ datapoints)
 SMT n=15 (n=15, 2+ datapoints)

Can a completion rate of 90% be
achieved? No: 80% achieved
Stated Reasons for Attrition
 Swine Flu n=2
 No improvement after 1 visit n=1
 Wants physical therapy n=1
 Lost faith in modality n=1
 Politics n=1
 Too busy n=1
 MVA n=1
 Too far n=1
 Friend died n=1
 No show/no response n=1
Can participants comply with exercise
expectation and treatment schedule?

Exercise
Consistent & >50% Improvement n=7
 Inconsistent & >50% Improvement n=5
 Consistent & <50% Improvement n=2
 Inconsistent & <50% Improvement n=2


Treatment schedule

To some degree
What is the average cost per participant?

Total cost $233/person

Study visit cost $160/person



Number of Study Visits 7.4 (3.14SD) Range 2-19
$20 per visit + $20 interview
Recruitment costs $50/person
Magazine ad $32/person
 Fliers, brochures, postage $18/person


Lab costs $23/person
SPECIFIC AIM #2
Are the study questions appropriate?
1.
Does intervention alter pain intensity or disability?
2.
Does pain intensity or disability influence intrauterine attachment?
3.
Does pain intensity or disability influence heart rate
variability?
4.
Does pain intensity or disability influence labor &
delivery complications?
Disability = Roland Morris Disability Index
Intensity = 11 point VAS
Intra-uterine attachment = Prenatal Attachment
Inventory
ROLAND MORRIS DESCRIPTIVE STATS
Group
(SD)
Start
(SD)
End
%
Improve
% Improve
50%
Exercise
10.7 (4.9)
6.1 (5.9)
38
55
NET
9.3 (3.7)
5.7 (4.7)
23
50
SMT
8.7 (4.1)
4.1 (4.3)
55
67
VAS PAIN INTENSITY DESCRIPTIVE STATS
Group
(SD)
Start
(SD)
End
%
Improve
% Improve
50%
Exercise
3.9 (1.5)
2.4 (1.8)
26
55
NET
3.2 (1.4)
2.4 (1.6)
10
35
SMT
3.5 (1.1)
1.9 (1.7)
44
53
LINEAR REGRESSION MODEL
Terms
RM Adjusted*
Mean Difference
(95% CI)
VAS Adjusted*
Mean Difference
(95% CI)
Ex vs. NET
0.7 (-2.9, 4.2)
0.1 (-1.0, 1.3)
Ex vs. SMT
0.01 (-3.2, 3.2)
-0.3 (-1.5, 1.0)
SMT vs. NET
1.2 (-2.1, 4.5)
0.5 (-0.8, 1.7)
*Adjusted for gestational age at entrance into the study, outcome
measure score at baseline, maternal age, and history of low back
pain
LABOR & DELIVERY OUTCOMES
Tx Grp
Ripen
n (%)
Induct
n (%)
Augmt
n (%)
Pain
Med
n (%)
Mec
n (%)
Nuchal
Cord
n (%)
Ex
(n=13)
2 (15)
4 (30)
7 (54)
7 (54)
4 (30)
4 (30)
NET
(n=11)
0
0
4 (36)
3 (27)
0
2 (18)
SMT
(n=10)
2 (20)
4 (40)
6 (60)
3 (30)
1 (10)
2 (20)
ANALYSIS NEXT STEPS
Heart Rate Variability
 Oxytocin
 Attachment




Prenatal Attachment Inventory
Adult Attachment Interview
Postpartum Mommy/Baby Video
THANKS TO OUR FUNDERS!
NCCAM/NIH 2T32AT0026888-06
 The ONE Foundation
 The Tartar Foundation
