Manipulative Therapy for Pregnancy and
Related Conditions: A Systematic ReviewThis section is compiled by Frank M. Painter, D.C.
Send all comments or additions to: Frankp@chiro.org
FROM: Obstet Gynecol Surv 2009 (Jun); 64 (6): 416–427 ~ FULL TEXT
Raheleh Khorsan, MA, Cheryl Hawk, DC, PhD, Anthony J. Lisi, DC, and Anupama Kizhakkeveettil, BAMS, MAOM
Military Medical Research and Integrative Medicine,
Samueli Institute,
Corona del Mar,
California 92625, USAObjective: The objective of this review is to evaluate the evidence on the effects of Spinal Manipulative Therapy (SMT) on back pain and other related symptoms during pregnancy.
Data sources: A literature search was conducted using Pubmed, Manual, Alternative and Natural Therapy Index System, Cumulated Index to Nursing and Allied Health, Index to Chiropractic Literature, the Cochrane Library, and Google Scholar. In addition hand searches and reference tracking were also performed, and the citation list was assessed for comprehensiveness by content experts.
Methods of study selection : This review was limited to peer-reviewed manuscripts published in English from 1966 until September 2008. The initial search strategy yielded 140 citations of which 12 studies were reviewed for quality.
Tabulation, integration, and results: The methodological quality of the included studies was assessed independently using quality checklists of the Scottish Intercollegiate Guidelines Network and Council on Chiropractic Guidelines and Practice Parameters. The review indicates that the use of SMT during pregnancy to reduce back pain and other related symptoms is supported by limited evidence.
Conclusion: Overall, this body of evidence is best described as emergent. However, since effective treatments for pregnancy-related back pain are limited, clinicians may want to consider SMT as a treatment option, if no contraindications are present.
Target audience: Obstetricians & Gynecologists, Family Physicians
Learning objectives: After completion of this article, the reader should be able to describe the concepts of spinal manipulative therapy and types of symptoms for which it might be considered in pregnancy, explain the quality of available research on the use of spinal manipulative therapy, and plan to discuss this therapy with interested pregnant patients.
From the Full-Text Article:
Introduction
It is estimated that 50% to 80% of women experience some form of musculoskeletal pain or related symptom during their pregnancy, which in some cases may become chronic. [1–3] Skaggs et al identified pregnancy-related pain at 3 major sites: low back pain, pelvic girdle pain, and mid-back pain. About two-thirds of all pregnant women report back pain sometime during their pregnancy. Pregnancyrelated pain is linked to sleep disturbance and negatively influences the patient’s quality of life. [4]
The structural, postural, and hormonal changes that occur during pregnancy may contribute to pregnancyrelated back and pelvic girdle pain. These changes include postural adaptations as the pregnancy progresses and the production of the hormone relaxin, which causes joints and ligaments to be more pliant. Previous history of back pain or injury may increase the risk of developing back and pelvic girdle pain during pregnancy. However, most studies have not been able to identify any single risk factor, etiology, or pathogenesis for developing any kind of back or pelvic girdle pain in pregnancy. [5]
Treatment options for back pain, pelvic girdle pain, and related symptoms during pregnancy are limited. Many medications used to treat pain are not recommended for use during pregnancy. Some patients are instructed to limit weight gain, exercise to strengthen the back muscles, maintain correct posture, and wear comfortable shoes. In one survey of underserved pregnant women in the United States, 85% perceived that they had not been offered treatment for their musculoskeletal disorders, and the care that they were provided was not satisfactory. [4] Alternative or complementary treatments such as massage or spinal manipulation may also provide some relief.
SPINAL MANIPULATION AS A THERAPEUTIC INTERVENTION
Spinal Manipulative Therapy (SMT), also referred to as Osteopathic Manipulative Therapy (OMT) or chiropractic adjustment, is the application of biomechanical force to synovial joints in the spinal column. Manipulation is usually characterized as a localized force of high velocity and low amplitude directed at a spinal segment. Mobilization uses low velocity passive movement techniques, within the spine’s normal range of movement. [6] In the United States, SMT is most commonly performed by chiropractors, osteopathic physicians, and physical therapists. Chiropractors perform about 94% of SMT in the United States. [7]
SMT is a widely used treatment option for musculoskeletal pain, especially back pain, in the general population. [8, 9] The annual use of chiropractic by the general public is between 8% and 12% (reported for 2002–2003) [10, 11] Generally the majority of patients seek chiropractic care for spine-related pain, particularly of the low back [12, 13] Severe adverse effects of SMT are rare, especially related to the lumbar spine. [14–16]
There are no definitive data for the use of SMT among pregnant women, although it is estimated that 76% of chiropractors practicing in the United States provide SMT to pregnant women. [17, 18] A survey by Allaire et al found that about 53% of North Carolina Certified Nurse-Midwives recommended chiropractic to their pregnant patients. [19] Another survey on the use, recommendation, and referral of complementary and alternative medicine (CAM) by Texas midwives reported that the most popular treatments for pregnancy-related musculoskeletal/back pain was chiropractic care. [20]
OSTEOPATHIC MANIPULATIVE TREATMENT AND CHIROPRACTIC ADJUSTMENT
Literature on the application of OMT in prenatal care dates to the first half of the 20th century. [21] These older articles were mainly commentaries describing specific OMT techniques or case reports reporting improved pregnancy outcomes. [22–27] By mid-century there was an increase in publications on the application of OMT in prenatal care. These studies had larger samples sizes, more complex research designs, and were empirically oriented, reflecting current osteopathic obstetric standards. [21, 28, 29] The articles on OMT in obstetrics published in the second half of the 20th century had a general theme of pain reduction during pregnancy and labor, especially lower back and pelvic pain. Chiropractic, like osteopathy, is a comprehensive form of therapy including a treatment plan based on the patient’s individual needs. Such a plan may include spinal manipulation, soft tissue therapy, prescription of exercises, and health and lifestyle counseling.
OBJECTIVES
There is substantial evidence from randomized controlled trials (RCTs) and systematic reviews supporting the effectiveness and safety of spinal manipulation for low back pain and neck pain. [8, 9, 30] The purpose of this review is to evaluate the evidence on the treatment effects of SMT and/or mobilization (including both chiropractic and osteopathic approaches) on back pain, pelvic girdle pain, and other related symptoms during pregnancy and labor. Because RCTs and other higher levels of evidence are often lacking for CAM therapies such as spinal manipulation, we included lower levels of evidence in this review, rather than restricting it only to higher levels, as is usually done in systematic reviews. A recent Cochrane review of CAM therapies for low back pain in pregnant women did not address spinal manipulation at all, because it considered only RCTs and other higher levels of evidence. Thus, clinicians are provided with no guidance with respect to this very commonly-used therapy. Eliminating lower level studies from even being considered is not in keeping with the practice of evidence-based decision-making, which relies on the best available scientific evidence — if higher level evidence is lacking, then it is important to consider the evidence that is available, while being mindful of its limitations.
SOURCES
The relevant studies were identified using the following databases: PubMed, an index to Medline (1966-September 2008), Manual, Alternative and Natural Therapy Index System (1966-September 2008), the Cochrane Library, Cumulated Index to Nursing and Allied Health (1982-September 2008), and Index to Chiropractic Literature (inception-September 2008), Google Scholar. In addition hand searches and reference tracking were also performed, and the citation list was assessed for comprehensiveness by content experts (Fig. 1).
The initial search was done by a librarian experienced in literature retrieval. Initial search terms were "chiropractic" AND "pregnant*"; "manipulation" AND "pregnant*." A second search strategy was done to ascertain retrieval of relevant articles because manipulation is a term related to both chiropractic and osteopathic medicine. The second search strategy consisted of MeSH or key terms related to the therapy (ie, manipulation) and population (pregnant women) such as Chiropractic "OR" Manipulation, Chiropractic OR Manipulation, Osteopathic OR Osteopathic Medicine "AND" Pregnancy OR Labor, Obstetric. We checked reference lists of relevant studies to identify cited articles not captured by electronic searches and contacted authors of primary studies who had e-mail addresses available.
Three reviewers (C.H., R.K., and A.L.) independently screened titles and abstracts for relevance and 2 reviewers (C.H. and R.K.) made an independent selection of studies for inclusion in this review. To avoid any misinterpretation, we excluded articles in languages other than English.
Articles were included if they met the following criteria:(1) published in a peer-reviewed journal (journals were considered peer-reviewed if they stated as such on their editorial page);
(2) English language;
(3) involved human subjects;
(4) addressed aspects of pregnancy, labor and/or childbirth; and
(5) addressed SMT or OMT.Articles were excluded if they:
(1) did not present original data or an analysis of original data (ie, commentaries, editorials, or expert opinion pieces);
(2) were published in other media or in incomplete formats (ie, abstracts, conference proceedings, posters, or web postings);
(3) did not address treatment outcomes;
(4) addressed exclusively nonmanual procedures (ie, exercise treatment, electrotherapy, use of a sacroiliac belt);
(5) addressed soft tissue treatment only (eg, massage); and
(6) addressed only sequelae of pregnancy and childbirth (ie, postpartum low back pain).This systematic review did not involve human or nonhuman experimentation and was exempt from Institutional Review Board approval.
QUALITY RATING
The methodological quality of the included studies was assessed independently by the reviewers (C.H., R.K., and A.L.). Each article was evaluated by type of study design and quality, with the exception of case reports, narrative reviews and descriptive surveys, which were NOT evaluated for quality (Table 1).
RCTs, systematic reviews, cohort studies, case-control studies, and controlled clinical trials (ie, nonrandomized, pilot, single group, and other small studies) were evaluated for quality using the Scottish Intercollegiate Guidelines Network (SIGN) checklists. [31, 32] The SIGN checklist rates studies as high quality (+) (indicates that the study met most or all criteria for that study design), low quality (–) (indicates that the study design was weak with few or no criteria fulfilled), or neutral (n) (indicates that, while it did not meet the majority of the criteria, the study had a neither exceptionally strong [ie, PLUS score] nor exceptionally weak design [ie, MINUS score]) (Table 2). For case series study design, we used an evaluation checklist developed and in use by the scientific commission of the Council on Chiropractic Guidelines and Practice Parameters. [33]
Case series have traditionally been excluded from most systematic reviews as they represent the lowest level of study evidence in most simple hierarchies of study design. [34] However, in emergent fields like CAM research, we felt that the inclusion of case series could assist clinicians in gaining a better perspective on the utility of SMT, as well as informing the design of future controlled studies. [35] Three coauthors independently rated each article. Differences in ratings were resolved by reconciliation, discussion, and consensus. Safety evaluation and adverse events reporting in all the clinical studies was assessed by 2 review members (C.H. and R.K.) and checked for consistency. All assessments were based on information provided in the published manuscript.
STUDY SELECTION
The search strategy yielded a total of 140 citations (no overlapping citations between databases) of which 32 [18–20,36–63] met our inclusion criteria. Of these,1 was a RCT [46],
2 systematic review [41, 64],
1 cohort study [39],
2 case-control studies [43, 48],
1 small nonrandomized static-group comparison study (preexperimental design) [54],
4 narrative reviews [38, 40, 47, 62],
6 case series [18, 42, 45, 50–52],
9 descriptive surveys [19, 20, 37, 53, 55, 56, 58, 60, 63], and
6 case reports (of 1–2 cases) [36, 44, 49, 57, 59, 61].
RESULTS
Quality Assessment and Trial Homogeneity
Thirteen (13) studies were reviewed for quality, as summarized in Table 3; the descriptive surveys, narrative reviews, and case reports were not rated for quality. Only 2 studies (1 case series and 1 case control) [18, 21] were classified as (+) meeting all or most of the measures of study design quality; 6 studies (4 were case series, [42, 45, 50, 52] and 2 were systematic reviews) [41, 64] scored (n) with neither exceptionally strong nor exceptionally weak design; and 5 remaining studies (1 cohort study [39], 1 case control [43], 1 other study design [54], 1 RCT [46], 1 case series [51], and scored as weak (–) indicating exceptionally weak study designs) (Table 3). Most studies had methodological limitations.
There were no RCTs or controlled clinical trials on the efficacy of SMT (including both chiropractic and osteopathic approaches) on back pain, pelvic girdle pain, and other related symptoms during pregnancy. For labor and delivery, one RCT (n = 15) measured the application of pressure via SMT to the lumbar area versus pressure applied to the thoracic area (as a placebo control) to inhibit back pain during labor and effectively reduce the need for analgesic medication during delivery. Because of the lack of clinical trials, study heterogeneity, small sample size, and poor design quality of the articles identified during the review phase we were unable to conduct a metaanalysis and total effect size. We did however, include methods for combining both qualitative and quantitative research in this systematic review by globally classifying the included studies as high quality, neutral, or low quality.
Overall the studies varied in inclusion criteria, treatment protocols and definitions of outcomes. The primary outcome in the majority of studies was patient reported pain relief. In the studies addressing back pain during labor, the use of pain medication was also used as an outcome measure; secondary outcomes included length of labor and mode of delivery (Table 3). Although the majority of the medical literature retrieved in the review involved chiropractic treatment almost one-third involved osteopathic treatment.
Adverse Events
Case reports and narrative reviews were included in Table 4 to describe the nature and severity of reported adverse events related to SMT or OMT during pregnancy. The majority of studies, including case reports, did not include reporting of adverse effects in their manuscript (Tables 3, 4). Two narrative reviews discussed possible contraindications to SMT during pregnancy and 3 clinical studies formally reported that no adverse events occurred.
Clinical Studies on Pregnancy, Labor, and Delivery
For labor and delivery, one RCT (n = 15) measured the application of pressure via SMT to the lumbar area versus pressure applied to the thoracic area (as a placebo control) to inhibit back pain during labor and effectively reduce the need for analgesic medication during delivery. The lumbar pressure was applied by the patient’s husband/coach or nurse. Lumbar pressure for back pain during labor had no significant effect on the length of labor. However, it significantly decreased pain medication use (P < 0.05). This RCT had a score of (–) using the SIGN methodology checklist for RCTs. The study design was weak and lacked an appropriate and clearly address question. The trial neither addressed randomization nor sample homogeneity. Of the clinical studies, only 1 case series [18] and 1 case-control study [21] were scored as (+) — adequately designed and methodologically sound. Both studies addressed the effect of SMT on pregnant women with low back pain.
A retrospective case series reported that 16 of the 17 cases demonstrated clinically important improvement in pain intensity throughout the course of treatment. The overall group average Numeric Rating Scale pain score decreased from 5.9 (range, 2–10) at initial presentation to 1.5 (range, 0–5) at termination of care. The average time to initial clinically important pain relief was 4.5 (range, 0–13) days after initial presentation, and the average number of visits undergone up to that point was 1.8 (range, 1–5). [18] Similarly, a second study (retrospective case control) to test the effectiveness of OMT during pregnancy found beneficial effects on the outcomes of pregnancy, labor, and delivery.
The medical records of 160 women from 4 cities who received prenatal OMT were reviewed for the occurrence of meconium-stained amniotic fluid, preterm delivery, use of forceps, and cesarean delivery. The randomly selected records of 161 women who were from the same cities, but who did not receive prenatal OMT were reviewed for the same outcomes. Prenatal OMT was significantly associated with decreased meconium-stained amniotic fluid (Z = 13.20, P < 0.001) and preterm delivery (Z = 9.91; P < 0.01), while the use of forceps was found to be marginally significant (Z = 3.28; P = 0.07). Overall, the results suggested improved outcomes in labor and delivery for women who received prenatal OMT, compared with women who did not. [21]
Other clinical studies also found that SMT during pregnancy successfully reduced back pain (Table 3).
Systematic Reviews
In 2001, a systematic review [41] on clinical studies and case reports of chiropractic technique procedures including SMT for specific low back conditions reviewed 143 articles. This review included only 2 case series [42, 52] involving pregnant women. This review was scored as (n) because it adequately addressed methodological issues, but failed to identify all relevant studies.
In 2008, a systematic review reported on chiropractic treatment of pregnancy-related low back pain. [64] All peer-reviewed articles were considered except single case reports, narrative reviews, and qualitative designs. Conference abstracts and proceedings were deemed acceptable for inclusion. Their electronic searches identified 55 citations (including overlapping citations between databases). The full text of 15 articles was obtained after screening the titles and/or abstracts to determine if they met the review’s inclusion criteria of which 6 articles met all of the inclusion/exclusion criteria of the review (3 abstracts, 1 retrospective cross-sectional survey [43], 1 retrospective case series [18], and 1 case series. [45] Although this review adequately addressed methodological issues and identified most of the relevant studies, we scored it as "n" because the evaluation instrument, a modified Downs and Black scale, is not appropriate for studies that describe outcomes in designs such as case series or survey. Checklist items regarding the allocation mechanism, random assignment, and blinding do not relate to case series. [34, 65]
Case Reports and Surveys
This systematic review reviewed 9 descriptive surveys [19, 20, 37, 53, 55, 56, 58, 60, 63] and 6 case reports (of 1–2 cases) [36, 44, 49, 57, 59, 61] of which 3 dealt with a chiropractic technique called the Webster Technique used to correct Breech presentation by manipulation of the sacrum (not involving external version of the fetus) [36, 55, 61], 3 addressed pelvic girdle pain during pregnancy [37, 53, 59], 2 case reports described SMT in the treatment of recurring lower back pain during pregnancy [44, 49], and 1 case report presented a case of an odontoid fracture occurring after SMT; the patient was found to have had a preexisting aneurysmal bone cyst [57] (Table 4). Of the remaining surveys, 1 surveyed the chiropractors’ opinions of the safety of SMT during pregnancy [60] and 5 surveys addressed CAM (including SMT) referrals from prenatal health care providers and prevalence recall of CAM use (including SMT) by pregnant women for back pain and breech presentation. [19, 20, 56, 58, 63]
DISCUSSION
This review provides healthcare professionals and the scientific community with a comprehensive evaluation of scientific literature on the treatment effects of SMT on back pain, pelvic girdle pain, and other related symptoms during pregnancy and labor.
This review was limited to peer-reviewed manuscripts published in English and published from 1966 until September 2008. However, its chief limitation was the paucity of literature. Our search indicated that a number of systematic and narrative reviews on CAM and pregnancy failed to include SMT as a treatment option (66–70). Furthermore, the reviews we identified omitted some relevant SMT studies. [38, 40, 41, 47, 62]
The 5 clinical studies — RCT [46], cohort study [39], 2 case-control studies [43, 48], and small nonrandomized static-group comparison study (preexperimental design) [54] evaluated did not permit this review to draw any definitive conclusions with respect to the effectiveness of SMT versus other treatments used on back pain and other related symptoms during pregnancy.
Most clinical studies reviewed contained design flaws such as a small sample size, duration of followup, control of cointerventions, the absence of a placebo control group, lack of blinding, proper analysis of dropouts, and a lack of description for the manipulative procedure. Furthermore, most of the clinical studies lacked sufficient description of their methodology, thus making it difficult for the reader to assess their validity and diminishing the ability to generalize the results to clinical practice. Although several clinical studies reported on sacroiliac joint pain, we were unable to find clinical studies that employed clear operational definitions to address pelvic girdle pain during pregnancy that met our inclusion criteria.
The case series included in this review suggest that SMT may be helpful to pregnant women with low back pain; however, this design does, of course, lack causal force. The 2 systematic reviews, focusing on RCTs, conclude that due to the small number and relatively low quality of the experimental studies available, this procedure needs further evaluation.
The treatment options for low back pain in pregnancy are limited. Although minimizing the use of medications during pregnancy is commonly accepted, no nonpharmacologic means is supported by strong evidence of safety and effectiveness. [71] Because there is evidence supporting the safety and effectiveness of manipulative therapies for low back pain in the general population [9], it appears reasonable to consider a trial of manipulative therapies for back pain in uncomplicated pregnancy, despite the small body of evidence focusing on the role of SMT for the special population of pregnant women. Current understanding of the biomechanics of manipulative therapies suggests that the transmitted loads are within physiological ranges [72, 73], and are thus not likely to be contraindicated in uncomplicated pregnancies.
CONCLUSION
In summary, the use of manipulative therapies (SMT or OMT) during pregnancy to reduce back pain and other related symptoms are supported by limited evidence; the evidence for the effects of manipulative therapies on labor and delivery is even more limited. Overall, this body of evidence is best described as emergent. Definitive evidence supporting its effectiveness has not yet been developed; however, definitive evidence supporting a lack of effectiveness is also lacking. Therefore, high quality clinical trials on safety and effectiveness should be a priority. However, until they are available, because safe and effective treatments for pregnancy-related back pain are limited, clinicians may want to consider SMT as a treatment option for patients who have a preference for this approach if no contraindications are present.
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