This is the current release of the guideline.

Low back pain

Patients with low back pain of musculoskeletal origin

Note: Patients with visceral disease conditions that refer pain to the low back are excluded from these guidelines. Other conditions of exclusion are when the following are the identified source of the low back pain: vertebral fracture; vertebral joint dislocation; muscle tears or lacerations; spinal or vertebral joint ligament rupture; inflammation of intervertebral discs, spinal zygapophyseal facets joints, muscles or fascia; skin lacerations; sacroiliitis; ankylosing spondylitis; or masses in or from the low back structures that are the source of the pain. Exclusion from this guideline does not imply that osteopathic manipulative treatment (OMT) is contraindicated in these conditions.

Osteopathic manipulative treatment (OMT) for somatic dysfunctions related to low back pain

Efficacy of osteopathic manipulation treatment in reducing low back pain

Evidence Collection

A search of the English language literature was performed through 2006 to identify reports of randomized controlled trials of osteopathic manipulative treatment (OMT). The guideline developers searched MEDLINE, OLDMEDLINE, EMBASE, MANTIS, OSTMED, Alt Health Watch, SciSearch, ClinicalTrials.gov, CRISP, and the Cochrane Central Register of Controlled Trials. The search strategy for computerized databases is provided in Appendix 1 of the original guideline document. Additionally, reports were sought from relevant reviews or meta-analyses of spinal manipulation manual searches of reference citations in the reviewed literature sources, systematic manual searches of key osteopathic journals, and consultation with other osteopathic investigators for identification of other reports of OMT trials.

Selection

The search bibliographies and relevant reports were reviewed by a series of trained reviewers to identify randomized controlled trials involving OMT in human subjects. To validly assess the efficacy of OMT in primary care, eligibility was limited to randomized controlled trials of OMT that included blinded assessment of low back pain in ambulatory settings. Trials that involved manipulation under anesthesia, industrial settings, or hospitalized patients were not included. Because there is potential confusion regarding the type of manipulation performed in some trials, the reported methods in each trial were carefully reviewed to assess eligibility for the meta-analysis.

Consequently, seven studies known or purported to involve OMT for low back pain were reviewed and excluded for not meeting eligibility criteria. A subsequent source indicated that an osteopathic manipulation technique was used in the Irvine study. Although several of the six included OMT trials were identified in multiple bibliographic databases, five were identified through MEDLINE. The Cleary trial was identified exclusively through the Cochrane Central Register of Controlled Trials. Another identified OMT trial that involved treatment of spinal pain, including neck pain, upper back pain, lower back pain, and combinations thereof, did not present anatomic site–specific data for review. The doctoral dissertation that served as the basis for this research and publication was successfully acquired in March 2007; however, this document did not provide the low back–specific data necessary for meta-analysis.

Six trials, involving eight osteopathic manipulative treatment (OMT) vs control treatment comparisons, were included.

Each eligible trial was independently evaluated by two reviewers to abstract data on methodological characteristics, osteopathic manipulative treatment and control treatments, and low back pain outcomes. Conflicting data were resolved by consensus.

Quantitative Data Synthesis

The guideline developers used the effect size, computed as Cohen's d statistic, to report all trial results. A negative effect size represented a greater decrease in pain among osteopathic manipulative treatment (OMT) subjects relative to control treatment subjects. Dichotomous pain measures were transformed to effect sizes by first computing the relevant P-value and then determining the effect size and 95% confidence interval (CI) that would obtain under the assumption of a two-tailed t-test for measuring the standardized mean difference between OMT and control treatments in the relevant number of subjects. The meta-analysis results were weighted by the inverse variance for each OMT vs control treatment comparison. The Q statistic was used to test the homogeneity of trials included in each analysis. The overall meta-analysis included the eight OMT vs control treatment comparisons. Four of the six trials, involving six of the eight OMT vs control treatment comparisons, each reported three contrasts. The median contrast was used to represent the pain outcome for each of these six comparisons (the median contrast refers to the intermediate effect size among the three reported pain outcomes for a given OMT vs control treatment comparison). These median contrasts were then combined with the lone contrasts reported in each of the two remaining OMT vs control treatment comparisons. Based on the similarity among trials, a fixed-effects model initially was used to perform meta-analysis and the results were then compared with those of a random-effects model. A series of sensitivity analyses were then performed. First, to address the possibility of bias by using the median contrasts method, analyses were repeated using the best-case and worst-case scenarios for the six relevant OMT vs control treatment comparisons. Second, to address the possibility of bias by including comparisons involving the same OMT group vs two different control treatment groups in two trials, analyses were repeated using only one OMT vs control treatment comparison for each of these trials. Each of the four possible combinations of contrasts was analyzed. Third, the analysis was repeated after excluding the Cleary trial. Finally, an analysis was performed using all 20 low back pain contrasts. Similar analyses were performed after stratifying trials according to control treatment, country where the trial was performed, and duration of follow-up. There were 43 analyses performed, including the overall meta-analysis, seven subgroup meta-analyses, and 35 sensitivity analyses. Meta-analysis was performed only when there were at least three contrasts available for data synthesis. Database management and analyses were performed using the Comprehensive Meta-Analysis software package (Version 1.0.23, Biostat, Inc, Englewood, NJ).

A subcommittee, under the direction of the Vice-Chair of the American Osteopathic Association (AOA) Bureau of Osteopathic Clinical Education and Research, was convened to explore the issue of osteopathic manipulative treatment and make recommendations to the AOA Board of Trustees and the AOA House of Delegates, with input from the AOA Bureau of Osteopathic Specialists, AOA Bureau of Scientific Affairs and Public Health, AOA Bureau on Socioeconomic Affairs, American Academy of Osteopathy, American College of Osteopathic Family Physicians, American College of Osteopathic Internists and the AOA Council on Research.

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Guidelines were reviewed by the American Osteopathic Association (AOA) Board of Trustees, Bureau of Osteopathic Specialists, Bureau of Osteopathic Clinical Education and Research, Council on Research, Bureau of Scientific Affairs and Public Health, Bureau of Socioeconomic Affairs, Department of Quality and Research, American College of Osteopathic Family Physicians (ACOFP), American Academy of Osteopathy (AAO), American College of Osteopathic Internists (ACOI) and the AOA House of Delegates.

The level of evidence (1a–5) definitions are repeated at the end of the "Major Recommendations" field.

It is recommended that osteopathic manipulative treatment (OMT) be utilized by osteopathic physicians for musculoskeletal causes of low back pain, i.e., to treat the diagnoses of somatic dysfunctions related to the low back pain. (Level of Evidence: 1a)

Definitions:

Level of Evidence

Adapted from Straus SE, Richardson WS, Glasziou P, and Haynes RB, Evidence-Based Medicine. How to Practice and Teach EBM (3rd ed), 2005.

An algorithm for osteopathic manipulative treatment (OMT) low back pain (LBP) decision making is provided in the original guideline document.

The type of supporting evidence is identified and graded for the recommendation (See "Major Recommendations" field).

Harms have not been identified in randomized clinical trials on osteopathic manipulative treatment (OMT) for patients with low back pain. OMT for somatic dysfunction has not demonstrated harm in any clinical trials to date.

One of the barriers to application of the recommendations cited by osteopathic physicians has been poor reimbursement for osteopathic manipulative treatment (OMT). However, Medicare has reimbursed osteopathic physicians for this procedure (ICD-9 code: 98926-9) for over 30 years. Many osteopathic physicians apparently do not utilize OMT in clinical practice due to a number of barriers, including time constraints, lack of confidence, loss of skill over time from disuse, and inadequate office space. Some specialists, i.e., pathologists and radiologists, do not use OMT as it is not applicable to their duties within their specialty. The American Osteopathic Association (AOA) believes patients with low back pain should be treated with OMT given the high level of evidence that supports its efficacy. Changes in care when this guideline is implemented will be determined by physician and patient surveys, billing and coding practice patterns amongst osteopathic physicians, data gathered from osteopathic physicians via the AOA's Clinical Assessment Program, and other registry data gathering tools currently being developed by researchers.

The clinical algorithm provided in the original guideline was adapted from: Chapter 4. The manipulative prescription. In: Nelson, Glonek, eds. Somatic Dysfunction in Osteopathic Family Medicine. Baltimore, MD: Lippincott Williams & Wilkins; 2007;27-32.

American Osteopathic Association

American Osteopathic Association, Bureau of Osteopathic Clinical Education and Research, Clinical Guideline Subcommittee on Low Back Pain

Michael Seffinger, D.O. (Chair); Boyd Buser, D.O.; John Licciardone, D.O., M.S., M.B.A., F.A.C.P.M; James Lipton, D.O., F.A.A.O.; John Lynch, D.O., M.P.H.; Michael Patterson, Ph.D.; Richard Snow, D.O., M.P.H.; Monte Troutman, D.O.

As the guidelines were developed based on the peer reviewed scientific literature, no conflict of interest is claimed by the developers. A well rounded, objective perspective is presented.

This is the current release of the guideline.

Electronic copies: Available in Portable Document Format (PDF) from the American Osteopathic Association Web site .

None available

None available

This summary was completed by ECRI Institute on May 7, 2010. The information was verified by the guideline developer on June 4, 2010.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.