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OBSTETRICS
A randomized controlled trial comparing a multimodal
intervention and standard obstetrics care for low
back and pelvic pain in pregnancy
James W. George, DC; Clayton D. Skaggs, DC; Paul A. Thompson, PhD;
D. Michael Nelson, MD, PhD; Jeffrey A. Gavard, PhD; Gilad A. Gross, MD
OBJECTIVE: Women commonly experience low back pain during preg- RESULTS: The MOM group demonstrated significant mean reductions
nancy. We examined whether a multimodal approach of musculoskele- in Numerical Rating Scale scores (5.8 ⫾ 2.2 vs 2.9 ⫾ 2.5; P ⬍ .001)
tal and obstetric management (MOM) was superior to standard obstet- and Quebec Disability Questionnaire scores (4.9 ⫾ 2.2 vs 3.9 ⫾ 2.4;
ric care to reduce pain, impairment, and disability in the antepartum P ⬍ .001) from baseline to follow-up evaluation. The group that
period. received standard obstetric care demonstrated no significant
STUDY DESIGN: A prospective, randomized trial of 169 women was improvements.
conducted. Baseline evaluation occurred at 24-28 weeks’ gestation, CONCLUSION: A multimodal approach to low back and pelvic pain in
with follow-up at 33 weeks’ gestation. Primary outcomes were the Nu- mid pregnancy benefits patients more than standard obstetric care.
merical Rating Scale (NRS) for pain and the Quebec Disability Question-
naire (QDQ). Both groups received routine obstetric care. Chiropractic Key words: back pain, exercise, manipulation, pregnancy
specialists provided manual therapy, stabilization exercises, and patient
education to MOM participants.
Cite this article as: George JW, Skaggs CD, Thompson PA, et al. A randomized controlled trial comparing a multimodal intervention and standard obstetrics care
for low back and pelvic pain in pregnancy. Am J Obstet Gynecol 2013;208:295.e1-7.
tension. Hypomobile joints were as- its in the office, or in an urgent care fa- tween BE and 33 weeks’ gestation to
sessed with the long dorsal ligament test, cility, the pain medication used, and days examine the effectiveness of the inter-
posterior PP provocation test, and clini- absent from work. An additional test, the vention at relieving LBP and PP during
cal palpation and were treated with rou- Patient’s Global Impression of Change, pregnancy. The primary outcome mea-
tine joint mobilization. Joint mobiliza- was included to assess the participant’s sures were the NRS and QDQ variables.
tion techniques were performed by perception of clinical improvement.27 Secondary outcomes included improve-
gently moving hypomobile joints in their The self-reported measures were the pri- ments in all other pain indices and re-
restricted directions to help restore mary outcome variables and were used ductions in medication use, trouble
proper range of motion. Muscle tension in the a priori power analysis to deter- sleeping, and work absenteeism. Gener-
was evaluated by clinical palpation and mine sample size. The physical assess- alized estimating equations techniques
was treated with postisometric relax- ment measures were secondary outcome were used to model discrete secondary
ation and myofascial release.25 The sta- variables between the 2 groups. Patients outcome variables over time. The Bon-
bilization exercises were targeted to in both the STOB and MOM groups re- ferroni correction was used to adjust for
strengthen the muscles that supported ceived care only from their obstetrics multiple comparisons (P ⬍ .05/10 ⫽ P ⬍
the low back and pelvis, because these providers after the visit at 33 weeks’ .005). All analyses were performed using
muscles maintain the spine and hip sta- gestation. SAS software (version 9.2 for Windows
bility that are important for the in- Power analysis used the NRS and the [Microsoft, Redmond, WA]; SAS Insti-
creased load that is created by preg- QDQ as the primary outcome variables. tute Inc, Cary, NC).
nancy. The gluteus maximus, gluteus Sample size for the QDQ was computed
medius, quadratus lumborum, abdomi- in the following manner: power, 0.9;
nal wall, and intrinsic spine muscles were standard deviation, 1.0; change of 1 for R ESULTS
targeted in the quadruped, supine, or the treatment group; change of 0.4 for Demographic and obstetric characteris-
side-lying positions. Patients were in- the control group; alpha, .05; 2-sided tics at BE were similar between the inter-
structed to perform their home exercise test; correlation between measurements, vention (MOM) and control (STOB)
program twice daily. Patient compliance 0.5; resulting in a number of 120. For the groups (Table 1). One hundred sixty-
with their home exercise program was NRS, a clinically meaningful difference nine patients were recruited, which rep-
not tracked but was encouraged with was defined as 2 units. Assuming a stan- resented 25 more than the original
each follow-up visit. dard deviation of 2 for each group, a cor- power calculations allotted. Recruitment
Self-administered exercises initially relation of 0.5 between measurements, occurred with a targeted dropout rate,
were selected from a standardized pro- and a STOB group change of 0.5 units, and data for all patients who were re-
tocol that is used for low back and pel- 120 patients would yield a power esti- cruited were analyzed. Despite the extra
vic stabilization.26 Sacroiliac belts were mate for the NRS to detect the listed patients, the 2 groups remained similar.
reserved for cases with significant hy- changes of 0.96. When we allowed for a No significant differences in any pain in-
permobility or when a patient’s pain 20% drop out rate, a sample size of 144 dex were found between the 2 groups at
restricted exercise performance.16 Pa- women was indicated as having adequate BE (Table 2). A significant reduction
tients who were assigned to the MOM power. from BE to 33 weeks’ gestation was
group had weekly appointments with Differences in demographic and ob- found on 7 pain indices in the MOM
the chiropractic specialist until 33 weeks’ stetric characteristics and pain indices at group (NRS, QDQ, SLR [left], active
gestation. BE between women in the MOM group SLR, long dorsal ligament test, PPH [leg
Each participant in the STOB and and the STOB group were assessed with and shoulders]) but on only 1 pain index
MOM groups was reevaluated at 33 either the 2 test (for categoric variables) in the STOB group (PPH [leg]). Women
weeks’ gestation to allow participants 4-6 or the t test (for continuous variables). in the STOB group reported a significant
treatments after the BE, which is an Mixed models repeated measures of increase from BE to 33 weeks’ gestation
amount of treatment that is typical in analysis was used to assess a 2-level fixed on 5 pain indices (QDQ, SLR [left and
clinical practice. The actual number of group effect (MOM vs STOB), a 2-level right], active SLR, and PPH [pubic/
treatment visits for individual partici- random time period effect (BE at 24-28 groin]). Interactions that indicated that
pants was not recorded. Reevaluation weeks’ gestation vs follow-up examina- the change from BE to 33 weeks’ gesta-
was done by the initial masked provider tion at 33 weeks’ gestation), and an inter- tion was significantly different for the
who was unaware of patient group allo- action effect of pain indices. Additional MOM and STOB groups were found for
cation and who used the self-reported within-group contrasts between time NRS, QDQ, SLR [left and right], poste-
measures and the same physical tests that points were performed for each of the rior PP provocation test [left], active
were used before random assignment, MOM and STOB groups; between- SLR, and long dorsal ligament test. The 2
with the following modifications. The group contrasts were performed be- groups did not differ on the use of pre-
PPH was edited to exclude redundant tween the MOM and STOB groups at scription or over-the-counter pain med-
questions and to include queries about each time point. We report the within- ications, trouble sleeping, or absentee-
routine visits, unscheduled provider vis- group and between-group findings be- ism from work at BE (Table 3). The
TABLE 2
Pain indices at baseline and 33 weeks’ gestation
Group: P value
Baseline to 33 Baseline 33 weeks’
Baseline 33 weeks’ Interaction: weeks’ gestation between gestation
Pain index Group examinationa gestation P value within the group groups between groups
Numeric rating scaleb MOM 5.8 ⫾ 2.2 2.9 ⫾ 2.5 ⬍ .01 ⬍ .001 .82 ⬍ .001
................................................................................................................................................................................................................................................................................................
STOB 5.7 ⫾ 2.2 5.6 ⫾ 3.0 .62
................................................................................................................................................................................................................................................................................................................................................................................
Quebec disability MOM 4.9 ⫾ 2.2 3.9 ⫾ 2.4 ⬍ .01 ⬍ .001 .43 ⬍ .001
................................................................................................................................................................................................................................................................................................
questionnaireb
STOB 4.7 ⫾ 1.9 5.3 ⫾ 2.2 ⬍ .01
................................................................................................................................................................................................................................................................................................................................................................................
Straight leg raise, n (%)
.......................................................................................................................................................................................................................................................................................................................................................................
Left MOM 47 (56.6) 16 (25.4) ⬍ .01 ⬍ .001 .15 ⬍ .001
................................................................................................................................................................................................................................................................................................
STOB 37 (45.7) 42 (60.9) .05
.......................................................................................................................................................................................................................................................................................................................................................................
Right MOM 40 (47.1) 22 (34.9) ⬍ .01 .06 .54 ⬍ .01
................................................................................................................................................................................................................................................................................................
STOB 34 (42.5) 43 (61.4) ⬍ .01
................................................................................................................................................................................................................................................................................................................................................................................
Posterior pelvic pain
provocation, n (%)
.......................................................................................................................................................................................................................................................................................................................................................................
Left MOM 55 (63.2) 32 (51.6) ⬍ .05 .11 .84 ⬍ 01
................................................................................................................................................................................................................................................................................................
STOB 51 (64.6) 53 (74.6) .15
.......................................................................................................................................................................................................................................................................................................................................................................
Right MOM 53 (60.9) 41 (64.1) .96 .68 .62 .60
................................................................................................................................................................................................................................................................................................
STOB 51 (64.6) 48 (67.6) .67
................................................................................................................................................................................................................................................................................................................................................................................
Active straight leg raise b
MOM 2.7 ⫾ 2.4 1.8 ⫾ 2.3 ⬍ .01 ⬍ .001 .86 ⬍ .001
................................................................................................................................................................................................................................................................................................
STOB 2.6 ⫾ 2.2 3.3 ⫾ 2.0 ⬍ .01
................................................................................................................................................................................................................................................................................................................................................................................
Long dorsal ligament test b
MOM 1.2 ⫾ 1.4 0.8 ⫾ 1.0 ⬍ .01 ⬍ .01 .52 ⬍ .001
................................................................................................................................................................................................................................................................................................
STOB 1.3 ⫾ 1.3 1.5 ⫾ 1.5 .44
................................................................................................................................................................................................................................................................................................................................................................................
Personal pain history, n (%)
.......................................................................................................................................................................................................................................................................................................................................................................
Leg MOM 62 (72.1) 34 (48.6) .26 ⬍ .001 .19 .91
................................................................................................................................................................................................................................................................................................
STOB 51 (63.0) 37 (50.0) ⬍ .05
.......................................................................................................................................................................................................................................................................................................................................................................
Arm MOM 22 (25.6) 16 (22.9) .78 .69 .57 .78
................................................................................................................................................................................................................................................................................................
STOB 23 (29.1) 19 (26.0) .47
.......................................................................................................................................................................................................................................................................................................................................................................
Pubic/groin MOM 39 (47.0) 35 (50.0) .27 .66 .41 ⬍ .05
................................................................................................................................................................................................................................................................................................
STOB 42 (52.5) 48 (65.8) ⬍ .05
.......................................................................................................................................................................................................................................................................................................................................................................
Shoulders MOM 44 (51.2) 22 (31.9) .13 ⬍ .01 .99 .09
................................................................................................................................................................................................................................................................................................
STOB 42 (51.9) 35 (47.3) .47
................................................................................................................................................................................................................................................................................................................................................................................
Patient global impression of MOM — 2.5 ⫾ 1.3 — — — ⬍ .001
changeb,c
................................................................................................................................................................................................................................................................................................................................................................................
STOB — 4.2 ⫾ 1.7 — — — —
................................................................................................................................................................................................................................................................................................................................................................................
MOM, multimodal musculoskeletal and obstetric management; STOB, standard obstetric care.
a
Baseline examination was performed at 24-28 weeks’ gestation; b Data are given as mean ⫾ SD; c Data obtained only at 33-week visit.
George. Low back and pelvic pain in pregnancy. Am J Obstet Gynecol 2013.
dard obstetrics care and sham ultra- cific patients based on the physical in 60 minutes 3 times a week under the
sound evaluation, although a reduction findings. supervision of a midwife improved
in pain was not different between the Exercises such as stabilization train- strength and reduced pain intensity of
groups.13 The authors used a similar ing, pelvic tilting, and water gymnas- women between 17 and 22 weeks’ ges-
combination of manual techniques tics benefit some pregnant women with tation, compared with control subjects
and also gave discretion to the treating LBP/PP.36 An intense program of 15 who did not exercise.12 Our exercise
physician to select procedures for spe- different exercises that were performed intervention, which was individualized
TABLE 3
Secondary outcome measures at baseline and 33 weeks’ gestation
Group: P value
Baseline-33 Baseline 33 weeks’
Baseline 33 weeks’ Interaction: weeks’ gestation between gestation between
Variable Group examinationa gestation P value within group groups groups
Prescription MOM 1.0 ⫾ 4.5 0.5 ⫾ 1.8 .46 .47 .71 .22
.......................................................................................................................................................................................................................................................................................................................
medication, db
STOB 1.3 ⫾ 4.8 1.5 ⫾ 5.7 .72
................................................................................................................................................................................................................................................................................................................................................................................
Over-the-counter MOM 5.8 ⫾ 8.9 2.8 ⫾ 5.7 .08 ⬍ .01 .88 .06
.......................................................................................................................................................................................................................................................................................................................
medications, db
STOB 5.9 ⫾ 8.7 5.4 ⫾ 9.7 .60
................................................................................................................................................................................................................................................................................................................................................................................
Trouble sleeping, MOM 66 (77.6) 34 (50.0) ⬍ .01 ⬍ .001 .98 ⬍ .01
.......................................................................................................................................................................................................................................................................................................................
n (%)
STOB 64 (78.0) 54 (73.0) .30
................................................................................................................................................................................................................................................................................................................................................................................
Absenteeism MOM 2.5 ⫾ 3.6 2.0 ⫾ 4.0 .85 .29 .71 .84
.......................................................................................................................................................................................................................................................................................................................
from work, db
STOB 2.3 ⫾ 3.8 1.9 ⫾ 4.1 .44
................................................................................................................................................................................................................................................................................................................................................................................
MOM, multimodal musculoskeletal and obstetric management; STOB, standard obstetric care.
a
Baseline examination was performed at 24-28 weeks’ gestation; b Data are given as mean ⫾ SD.
George. Low back and pelvic pain in pregnancy. Am J Obstet Gynecol 2013.
for each patient by the chiropractic teria and were interested in participa- 4. Mogren IM, Pohjanen AI. Low back pain and
provider, consisted of ⱕ4 exercises tion. Our exclusion criteria were neces- pelvic pain during pregnancy: prevalence and
risk factors. Spine 2005;30:983-91.
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5. Haugland KS, Rasmussen S, Daltveit AK.
suggests that a less intense, self-admin- patients who were motivated to achieve Group intervention for women with pelvic girdle
istered exercise program may provide successful results. Responses to com- pain in pregnancy: a randomized controlled
an equal benefit to reduce pain and to plaints of LBP/PP may vary among ob- trial. Acta Obstet Gynecol Scand 2006;85:
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