A Randomized Controlled Trial Comparing A Multimodal Intervention and Standard Obstetrics Care For Low Back and Pelvic Pain In Pregnancy

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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

Chiropractic Science Division,
College of Chiropractic,
Logan University,
Chesterfield, MO, USA.
james.george@logan.edu


OBJECTIVE:   Women commonly experience low back pain during pregnancy. We examined whether a multimodal approach of musculoskeletal and obstetric management (MOM) was superior to standard obstetric care to reduce pain, impairment, and disability in the antepartum period.

STUDY DESIGN:   A prospective, randomized trial of 169 women was conducted. Baseline evaluation occurred at 24-28 weeks’ gestation, with follow-up at 33 weeks’ gestation. Primary outcomes were the Numerical Rating Scale (NRS) for pain and the Quebec Disability Questionnaire (QDQ). Both groups received routine obstetric care. Chiropractic specialists provided manual therapy, stabilization exercises, and patient education to MOM participants.

RESULTS:   The MOM group demonstrated significant mean reductions in Numerical Rating Scale scores (5.8 ± 2.2 vs 2.9 ± 2.5; P < .001) and Quebec Disability Questionnaire scores (4.9 ± 2.2 vs 3.9 ± 2.4; P < .001) from baseline to follow-up evaluation. The group that received standard obstetric care demonstrated no significant improvements.

CONCLUSION:   A multimodal approach to low back and pelvic pain in mid pregnancy benefits patients more than standard obstetric care.


From the Full-Text Article:

Introduction

Musculoskeletal pain in pregnant women commonly is viewed as transient, physiologic, and self-limited. However, most women report either low back pain (LBP) or pelvic pain (PP) during pregnancy [1-6] and the morbidity that is associated with such complaints. [7, 8] Moreover, up to 40% of patients report musculoskeletal pain during the 18 months after delivery, [2, 7, 9, 10] and one-fifth of these women have severe LBP that leads to major personal, social, or economic problems. [7, 9, 11] Pregnancy-related LBP contributes substantially to health care costs. For example, one-fifth of pregnant women in Scandinavian countries experience back pain as an indication for up to 7 weeks of sick leave in the perinatal period. [7, 9] Ninety-four percent of women who experienced LBP in an index pregnancy have recurrent symptoms with subsequent pregnancy, and two-thirds of these patients experience disability and require sick leave during pregnancy. Notably, 19% of women with pain in an initial pregnancy report avoidance of a future pregnancy out of fear of recurrence of the musculoskeletal symptoms. [11]

Most past investigations that have evaluated interventions to reduce morbidity in women with LBP/PP during pregnancy have used modalities that have included prescription exercise, [12] manual manipulation, [13] education, [14] acupuncture, [15] or pelvic belts. [16] Recently, a multimodal randomized trial compared osteopathic manipulation to usual obstetric care and sham ultrasonic therapy on 144 participants. [13] Importantly, this trial did not include behavioral and exercise therapies. We conducted a prospective, randomized, masked clinical trial to test the hypothesis that a multimodal approach of manual therapy, exercise, and education for LBP/PP in pregnant women is superior to standard obstetric care (STOB) for the reduction of pain, impairment, and disability in the ante-partum period.


COMMENT

Our data reject the null hypothesis that the effects of a multimodal approach to treating LBP/PP that is specific to pregnancy are not different from standard obstetric care. We have shown that a combination of manual therapy, exercise, and patient education reduces pain and disability when applied at 24-33 weeks’ gestation. The benefits derived are both subjective and objective. Patients perceived less pain and disability and an overall global improvement in daily activities. Their physical examinations revealed improved range of motion, stability, and less irritation at the lumbar and pelvic joints. Notably, no adverse events were reported in either group. We conclude that a multimodal approach to musculoskeletal LBP/PP that is instituted in the late second and early third trimesters of pregnancy benefits patients above and beyond standard obstetrics provider care.

Disability with pregnancy-related LBP causes some patients to restrict normal activities and to seek sick leave. [1, 8, 9] Contributing factors to LBP and PP in pregnancy include increased spine load from body habitus changes and joint hypermobility from the hormonal environment characteristic of pregnancy. [4] Importantly, there is little relationship between pregnancy-related back pain and structural disease, such as disc disease or spondylolisthesis. 28 Women with LBP/PP during pregnancy often report pain that progresses in severity throughout the day, which is a presentation that is consistent with overuse during the activities of daily living. [29, 30] This contrasts with the localized inflammation of a herniated disc, for which pain is highest in the morning and improves with mobility. [31] These findings are reassuring that LBP/PP during pregnancy are unlikely linked to a structural source; although without imaging, lumbar structural disease cannot be ruled out completely. The cause of the symptoms instead reflects a combination of biomechanical factors that yield abnormal loading on muscles and joints and behavioral factors that are related to inadequate patient coping strategies. [32-34] The foundation for the multimodal approach to back pain was based, in part, on these premises.

Chiropractic interventions and education, meshed with standard prenatal practice, led to an improvement in the MOM group that were not observed in the STOB group between 24 and 33 weeks’ gestation, as assessed by the self-report NRS and QDQ questionnaires. The 33 weeks’ gestation assessment of the patient global improvement change and most, but not all, tests of physical assessment at 33 weeks’ gestation were better in the MOM group, compared with the STOB group. These results suggest that the multimodal approach in the MOM treatment in pregnancy reduces pain and discomfort, while improving the quality of daily activities for pregnant women who experience LBP/PP. We cannot state which of the 3 components of the multimodal approach was most influential in the outcome that was observed because there is support for each component; manual therapy, exercise, and education.

Chiropractic manipulation reduced pain in a retrospective case series of pregnant women. [35] Murphy et al [14] conducted an observational study of chiropractic manipulation as part of a diagnosis-based clinical decision rule to treat pregnancy-related lumbar-PP. Clinically significant improvements in disability were found in 73% of patients; 82% of patients demonstrated clinically significant reductions in pain. This was not a randomized trial, nor was there a control group. Recently, osteopathic manipulation was found to slow the progression of deterioration of back-specific functioning when compared with standard obstetrics care and sham ultrasound evaluation, although a reduction in pain was not different between the groups. [13] The authors used a similar combination of manual techniques and also gave discretion to the treating physician to select procedures for specific patients based on the physical findings.

Exercises such as stabilization training, pelvic tilting, and water gymnastics benefit some pregnant women with LBP/PP. [36] An intense program of 15 different exercises that were performed in 60 minutes 3 times a week under the supervision of a midwife improved strength and reduced pain intensity of women between 17 and 22 weeks’ gestation, compared with control subjects who did not exercise. [12] Our exercise intervention, which was individualized for each patient by the chiropractic provider, consisted of 4 exercises that were performed at home. This suggests that a less intense, self-administered exercise program may provide an equal benefit to reduce pain and to allow the patient to conduct the exercises in her home.

Patient education has long been a staple of care for LBP. Patients with poor coping strategies, such as catastrophizing and fear-avoidance, have poorer outcomes compared with those who show insights into symptoms and greater self-efficacy. [14] Notably, fear avoidance behaviors decondition and weaken muscle tissue, which in turn leads to less spine stability. Our education component emphasized these issues and yielded improved perceptions. Biopsychosocial education or education on self-treatment and decreasing fear avoidance are alternative approaches for improving symptoms of LBP/PP in pregnant women. [37]

Major strengths of our study included the randomized clinical trial design and the application to a population with a diverse socioeconomic status, which commonly is observed in general obstetrics practice. An additional strength was the use of a comprehensive multimodal approach. Our study had limitations. We screened 2500 patients and enrolled only 169 women who met inclusion criteria and were interested in participation. Our exclusion criteria were necessarily numerous, and we likely enrolled patients who were motivated to achieve successful results. Responses to complaints of LBP/PP may vary among obstetrics providers, which could not be controlled completely in either group. Our data also could not discern which specific treatment or combination of treatments provided the most clinical benefit. Some benefits are reported for each modality in the non-randomized trials cited earlier. In addition, our trial did not use sham treatments, nor was placebo controlled; thus, placebo effect could have contributed to patients’ improvement. Last, this trial did not evaluate the use of prophylactic treatment, which is a potentially important component to therapy that warrants future study in pregnant populations

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