Research Review By Dr. Ceara Higgins©

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Date Posted:

April 2013

Study Title:

A randomized controlled trial comparing a multimodal intervention and standard obstetrics care for low back and pelvic pain in pregnancy

Authors:

George JW, Skaggs CD, Thompson PA et al.

Author's Affiliations:

Chiropractic Science Division, Logan University, Chesterfield; The Central Institute for Human Performance; The Division of Maternal Fetal Medicine and Ultrasound, Department of Obstetrics and Gynecology, Washington University School of Medicine; The Divisions of Research and Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Women’s Health, St. Louis University School of Medicine; and the Department of Pediatrics, Sanford Research, Sanford Health, University of South Dakota.

Publication Information:

American Journal of Obstetrics & Gynecology 2013; 208(4): 295.e1-7.

Background Information:

Low back (LBP) and pelvic pain (PP) during pregnancy are known to be significant problems. Their effects can last well beyond pregnancy as well, with up to 40% of women with pregnancy related pain reporting symptoms up to 18 months post-partum. Further, 19% of women with musculoskeletal pain in their first pregnancy report avoiding getting pregnant again due to fear of being in pain (1)!

Previous studies have explored the effects of exercise, manual manipulation, education, acupuncture, or pelvic belts on pregnancy related LBP and PP, but none have explored using these types of interventions in combination with one another. That was the goal of this study, which examined whether a multimodal approach of musculoskeletal and obstetric management (MOM) was superior to standard obstetric care to relieve pain and reduce impairment, and disability in the antepartum period.

Pertinent Results:

  • At baseline, there were no significant differences found in pain indexes between groups.
  • At 33 weeks gestation, a significant reduction was found in 7 pain indices (NRS, QDQ, SLR [left], active SLR, long dorsal ligament test, and PPH [leg and shoulder]) in the MOM group, but only in the PPH [leg] in the STOB group.
  • Participants in the STOB group reported an increase in pain in the QDQ, SLR [right and left], active SLR, and PPH [pubic/groin] at 33 weeks of gestation.
  • At baseline, there were no differences shown between the two groups in the use of over-the-counter or prescription pain medication, trouble sleeping, or absenteeism from work.
  • At 33 weeks gestation, the MOM group reported significantly less difficulty sleeping than the STOB group.
  • There were no significant differences noted in the other areas.

Clinical Application & Conclusions:

It can be concluded that the combination of manual therapy, exercise, and patient education better reduces pain and disability, both subjectively and objectively than standard obstetrics care alone, when applied during the late second and early third trimesters.

The low number of exercises given to participants gives an initial indication that less intense exercise programs administered at home may be as effective as more intense, gym-based (or supervised) programs. Further investigation into this concept is warranted. An education program based on biopsychosocial education aimed at decreasing fear avoidance also appears beneficial to patients with pregnancy related LBP or PP.

Patients who present to their obstetric doctors with low back or pelvic pain during the second and third trimesters would be well served by a referral for prudent manual therapy delivered by a chiropractor or physiotherapist to promote pain reduction and improved quality of daily living.

Study Methods:

Subjects for the study were recruited from 3 different obstetric and gynecological clinics. To be included, subjects had to be:
  • Between 15-45 years of age and pregnant with a single fetus (between 24-28 weeks of gestation)
  • Experiencing LBP or PP as diagnosed by their obstetric provider
Subjects were excluded is they had acute inflammatory disease, acute infectious disease, chronic back pain lasting more than 8 weeks before pregnancy, mental health disorders, back pain due to visceral disease, ongoing treatment for pre-existing back pain, peripheral vascular disease, substance abuse, or litigation pending from back pain.

169 subjects were included in the study. All participants were evaluated by a chiropractic specialist before being randomized into study groups. These groupings included a group receiving standard obstetric care (STOB) and a group receiving standard obstetric care plus multimodal musculoskeletal and obstetric treatment (MOM).

The baseline evaluation performed by the chiropractic specialist included subjective evaluation of pain using the numeric rating scale (NRS), Quebec Task Force Disability Questionnaire (QDQ), and the personal pain history (PPH) and physical assessment using the straight leg raise (SLR), posterior PP provocation test, active SLR, and long dorsal ligament test.

Patients randomized to the STOB group received care from an obstetric provider of their choosing at their individually recommended frequency, and received recommendations of one or more remedies, including rest, aerobic exercise, application of heating pads for up to 10 minutes, use of acetaminophen, or use of narcotics. In cases where patients experienced pain which was debilitating, or if they failed to respond to standard modalities, a referral to orthopaedic or neurological services was made.

Those randomized to the MOM group received care from their own obstetric provider with the same stipulations as the STOB group. These individuals also received weekly visits with a chiropractic specialist, which included education, manual therapy, and stabilization exercises. All treatment was based in the biopsychosocial model, which states that pain syndromes are not solely the result of injury to body structures, but also are affected by social and psychological factors such as fear of movement and high expectancy of pain. Manual therapy was performed based on clinical findings and aimed at correcting hypomobility of joints. Areas of muscle tension were treated with myofascial release and postisometric relaxation. Finally, exercises were prescribed aimed at strengthening support muscles in the low back and pelvis. Participants were each given an individualized exercise program consisting of no more than 4 exercises.

Both groups were reassessed at 33 weeks of gestation using the initial outcome measures, queries about routine visits, unscheduled provider visits in office or in urgent care facilities, pain medication used, days absent from work, and the Patient`s Global Impression of Change. After 33 weeks of gestation, all participants only received care from their obstetrics providers.

Study Strengths / Weaknesses:

Strengths:
  • The similarity between the study groups at baseline ensures that the results were not unduly affected by the initial condition of the participants. As well, the diverse socioeconomic status of the study group and the randomized clinical trial design allows us to apply the results to the variety of patients commonly seen in obstetrics practice.
Weaknesses:
  • Home exercises were prescribed to all subjects in the MOM group, but participants were not monitored with respect to their compliance to the program. This limits our ability to speculate on the contribution of exercise to the clinical benefits observed in this group.
  • The actual number of treatments received by each participant was not recorded. This makes the treatment difficult to reproduce and calls into question the subject’s compliance in their prescribed home care.
  • Further, the extensive exclusion criteria used and the inclusion of only patients with a desire to participate in the study likely resulted in the participant group being motivated to achieve successful results and possibly more likely to achieve those results.
  • The obstetric care provided to each participant could not be controlled and likely varied. This combined with the multimodal treatment makes it impossible discern which treatment or treatment combination would provide the greatest clinical benefits. The lack of a sham (control) treatment also prevents evaluation of the placebo effect and it’s impact of the improvements seen.

Additional References:

  1. Brynhildsen J, Hansson A, Persson A, Hammard M. Follow-up of patients with low back pain during pregnancy. Obstet Gynecol 1998; 91:182-6.