A randomized, controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel

BackgroundOsteopathic manipulative treatment (OMT) is a distinctive modality commonly used by osteopathic physicians to complement their conventional treatment of musculoskeletal disorders. Previous reviews and meta-analyses of spinal manipulation for low back pain have not specifically addressed OMT and generally have focused on spinal manipulation as an alternative to conventional treatment. The purpose of this study was to assess the efficacy of OMT as a complementary treatment for low back pain.MethodsComputerized bibliographic searches of MEDLINE, EMBASE, MANTIS, OSTMED, and the Cochrane Central Register of Controlled Trials were supplemented with additional database and manual searches of the literature.Six trials, involving eight OMT vs control treatment comparisons, were included because they were randomized controlled trials of OMT that involved blinded assessment of low back pain in ambulatory settings. Data on trial methodology, OMT and control treatments, and low back pain outcomes were abstracted by two independent reviewers. Effect sizes were computed using Cohen's d statistic and meta-analysis results were weighted by the inverse variance of individual comparisons. In addition to the overall meta-analysis, stratified meta-analyses were performed according to control treatment, country where the trial was conducted, and duration of follow-up. Sensitivity analyses were performed for both the overall and stratified meta-analyses.ResultsOverall, OMT significantly reduced low back pain (effect size, -0.30; 95% confidence interval, -0.47 – -0.13; P = .001). Stratified analyses demonstrated significant pain reductions in trials of OMT vs active treatment or placebo control and OMT vs no treatment control. There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States. Significant pain reductions were also observed during short-, intermediate-, and long-term follow-up.ConclusionOMT significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.

Managing Nontraumatic Acute Back Pain

We studied the efficacy of osteopathic manual treatment (OMT) and ultrasound therapy (UST) for chronic low back pain. A randomized, double-blind, sham-controlled, 2 × 2 factorial design was used to study OMT and UST for short-term relief of nonspecific chronic low back pain. The 455 patients were randomized to OMT (n = 230) or sham OMT (n = 225) main effects groups, and to UST (n = 233) or sham UST (n = 222) main effects groups. Six treatment sessions were provided over 8 weeks. Intention-to-treat analysis was performed to measure moderate and substantial improvements in low back pain at week 12 (30% or greater and 50% or greater pain reductions from baseline, respectively). Five secondary outcomes, safety, and treatment adherence were also assessed. There was no statistical interaction between OMT and UST. Patients receiving OMT were more likely than patients receiving sham OMT to achieve moderate (response ratio [RR] = 1.38; 95% CI, 1.16-1.64; P <.001) and substantial (RR = 1.41, 95% CI, 1.13-1.76; P = .002) improvements in low back pain at week 12. These improvements met the Cochrane Back Review Group criterion for a medium effect size. Back-specific functioning, general health, work disability specific to low back pain, safety outcomes, and treatment adherence did not differ between patients receiving OMT and sham OMT. Nevertheless, patients in the OMT group were more likely to be very satisfied with their back care throughout the study (P <.001). Patients receiving OMT used prescription drugs for low back pain less frequently during the 12 weeks than did patients in the sham OMT group (use ratio = 0.66, 95% CI, 0.43-1.00; P = .048). Ultrasound therapy was not efficacious. The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.

A randomised controlled trial on the effectiveness of osteopathic manipulative treatment of chronic low back pain

ObjectivesTo investigate the efficacy of non-surgical and non-interventional treatments for adults with low back pain compared with placebo.Eligibility criteriaRandomised controlled trials evaluating non-surgical and non-interventional treatments compared with placebo or...

Low back pain is usually nonspecific or mechanical. Mechanical low back pain arises intrinsically from the spine, intervertebral disks, or surrounding soft tissues. Clinical clues, or red flags, may help identify cases of nonmechanical low back pain and prompt further evaluation or imaging. Red flags include progressive motor or sensory loss, new urinary retention or overflow incontinence, history of cancer, recent invasive spinal procedure, and significant trauma relative to age. Imaging on initial presentation should be reserved for when there is suspicion for cauda equina syndrome, malignancy, fracture, or infection. Plain radiography of the lumbar spine is appropriate to assess for fracture and bony abnormality, whereas magnetic resonance imaging is better for identifying the source of neurologic or soft tissue abnormalities. There are multiple treatment modalities for mechanical low back pain, but strong evidence of benefit is often lacking. Moderate evidence supports the use of nonsteroidal anti-inflammatory drugs, opioids, and topiramate in the short-term treatment of mechanical low back pain. There is little or no evidence of benefit for acetaminophen, antidepressants (except duloxetine), skeletal muscle relaxants, lidocaine patches, and transcutaneous electrical nerve stimulation in the treatment of chronic low back pain. There is strong evidence for short-term effectiveness and moderate-quality evidence for long-term effectiveness of yoga in the treatment of chronic low back pain. Various spinal manipulative techniques (osteopathic manipulative treatment, spinal manipulative therapy) have shown mixed benefits in the acute and chronic setting. Physical therapy modalities such as the McKenzie method may decrease the recurrence of low back pain and health care expenditures. Physical therapy modalities such as the McKenzie method may decrease the recurrence of low back pain and use of health care. Educating patients on prognosis and incorporating psychosocial components of care such as identifying comorbid psychological problems and barriers to treatment are essential components of long-term management.

A randomized controlled trial was conducted. To determine the efficacy of osteopathic manipulative treatment as a complementary treatment for chronic nonspecific low back pain. Osteopathic manipulative treatment may be useful for acute or subacute low back pain. However, its role in chronic low back pain is unclear. This trial was conducted in a university-based clinic from 2000 through 2001. Of the 199 subjects who responded to recruitment procedures, 91 met the eligibility criteria. They were randomized, with 82 patients completing the 1-month follow-up evaluation, 71 completing the 3-month evaluation, and 66 completing the 6-month evaluation. The subjects were randomized to osteopathic manipulative treatment, sham manipulation, or a no-intervention control group, and they were allowed to continue their usual care for low back pain. The main outcomes included the SF-36 Health Survey, a 10-cm visual analog scale for overall back pain, the Roland-Morris Disability Questionnaire, lost work or school days because of back pain, and satisfaction with back care. As compared with the no-intervention control subjects, the patients who received osteopathic manipulative treatment reported greater improvements in back pain, greater satisfaction with back care throughout the trial, better physical functioning and mental health at 1 month, and fewer cotreatments at 6 months. The subjects who received sham manipulation also reported greater improvements in back pain and physical functioning and greater satisfaction than the no-intervention control subjects. There were no significant benefits with osteopathic manipulative treatment, as compared with sham manipulation. Osteopathic manipulative treatment and sham manipulation both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain. It remains unclear whether the benefits of osteopathic manipulative treatment can be attributed to the manipulative techniques themselves or whether they are related to other aspects of osteopathic manipulative treatment, such as range of motion activities or time spent interacting with patients, which may represent placebo effects.

PurposeTo assess response to osteopathic manual treatment (OMT) according to baseline severity of chronic low back pain (LBP). MethodsThe OSTEOPATHIC Trial used a randomized, double-blind, sham-controlled, 2×2 factorial design to study OMT for chronic LBP. A total of 269 (59%) patients reported low baseline pain severity (LBPS) (<50mm/100mm), whereas 186 (41%) patients reported high baseline pain severity (HBPS) (≥50mm/100mm). Six OMT sessions were provided over eight weeks and outcomes were assessed at week 12. The primary outcome was substantial LBP improvement (≥50% pain reduction). The Roland–Morris Disability Questionnaire (RMDQ) and eight other secondary outcomes were also studied. Response ratios (RRs) and 95% confidence intervals (CIs) were used in conjunction with Cochrane Back Review Group criteria to determine OMT effects. ResultsThere was a large effect size for OMT in providing substantial LBP improvement in patients with HBPS (RR, 2.04; 95% CI, 1.36–3.05; P<0.001). This was accompanied by clinically important improvement in back-specific functioning on the RMDQ (RR, 1.80; 95% CI, 1.08–3.01; P=0.02). Both RRs were significantly greater than those observed in patients with LBPS. Osteopathic manual treatment was consistently associated with benefits in all other secondary outcomes in patients with HBPS, although the statistical significance and clinical relevance of results varied. ConclusionsThe large effect size for OMT in providing substantial pain reduction in patients with chronic LBP of high severity was associated with clinically important improvement in back-specific functioning. Thus, OMT may be an attractive option in such patients before proceeding to more invasive and costly treatments.

ImportanceIt is critically important to evaluate the effect of nonpharmacological treatments on low back pain and associated disability.ObjectiveTo determine whether the addition of chiropractic care to usual medical care results in better pain relief and pain-related function when compared with usual medical care alone.Design, Setting, and ParticipantsA 3-site pragmatic comparative effectiveness clinical trial using adaptive allocation was conducted from September 28, 2012, to February 13, 2016, at 2 large military medical centers in major metropolitan areas and 1 smaller hospital at a military training site. Eligible participants were active-duty US service members aged 18 to 50 years with low back pain from a musculoskeletal source.InterventionsThe intervention period was 6 weeks. Usual medical care included self-care, medications, physical therapy, and pain clinic referral. Chiropractic care included spinal manipulative therapy in the low back and adjacent regions and additional therapeutic procedures such as rehabilitative exercise, cryotherapy, superficial heat, and other manual therapies.Main Outcomes and MeasuresCoprimary outcomes were low back pain intensity (Numerical Rating Scale; scores ranging from 0 [no low back pain] to 10 [worst possible low back pain]) and disability (Roland Morris Disability Questionnaire; scores ranging from 0-24, with higher scores indicating greater disability) at 6 weeks. Secondary outcomes included perceived improvement, satisfaction (Numerical Rating Scale; scores ranging from 0 [not at all satisfied] to 10 [extremely satisfied]), and medication use. The coprimary outcomes were modeled with linear mixed-effects regression over baseline and weeks 2, 4, 6, and 12.ResultsOf the 806 screened patients who were recruited through either clinician referrals or self-referrals, 750 were enrolled (250 at each site). The mean (SD) participant age was 30.9 (8.7) years, 175 participants (23.3%) were female, and 243 participants (32.4%) were nonwhite. Statistically significant site × time × group interactions were found in all models. Adjusted mean differences in scores at week 6 were statistically significant in favor of usual medical care plus chiropractic care compared with usual medical care alone overall for low back pain intensity (mean difference, −1.1; 95% CI, −1.4 to −0.7), disability (mean difference, −2.2; 95% CI, −3.1 to −1.2), and satisfaction (mean difference, 2.5; 95% CI, 2.1 to 2.8) as well as at each site. Adjusted odd ratios at week 6 were also statistically significant in favor of usual medical care plus chiropractic care overall for perceived improvement (odds ratio = 0.18; 95% CI, 0.13-0.25) and self-reported pain medication use (odds ratio = 0.73; 95% CI, 0.54-0.97). No serious related adverse events were reported.Conclusions and RelevanceChiropractic care, when added to usual medical care, resulted in moderate short-term improvements in low back pain intensity and disability in active-duty military personnel. This trial provides additional support for the inclusion of chiropractic care as a component of multidisciplinary health care for low back pain, as currently recommended in existing guidelines. However, study limitations illustrate that further research is needed to understand longer-term outcomes as well as how patient heterogeneity and intervention variations affect patient responses to chiropractic care.Trial RegistrationClinicalTrials.gov Identifier: NCT01692275

Osteopathic physicians are trained to treat patients with musculoskeletal symptoms, to treat somatic dysfunction with osteopathic manipulative treatment (OMT), and to avoid unnecessarily prescribing drugs such as opioids. It is also generally believed that osteopathic physicians provide a unique patient-centered approach to medical care that involves effective communication and empathy. Such training and characteristics of osteopathic medical care (OMC) may enhance clinical outcomes among patients with chronic pain. The objectives of this study were to measure and compare the process and longitudinal outcomes of chronic low back pain (CLBP) treatment provided by osteopathic and allopathic physicians and to identify mediators of the treatment effects of OMC. This retrospective cohort study was conducted utilizing adult participants with CLBP within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION) from April 2016 through December 2022. Participants having an osteopathic or allopathic physician for at least 1month prior to registry enrollment were included and followed at quarterly intervals for up to 12months. Physician communication and physician empathy were measured at registry enrollment. Opioid prescribing and effectiveness and safety outcomes were measured at registry enrollment and for up to 12months and were analyzed with generalized estimating equations to compare participants treated by osteopathic vs. allopathic physicians. Multiple mediator models, including physician communication, physician empathy, opioid prescribing, and OMT, with covariate adjustments, were utilized to identify mediators of OMC treatment effects. A total of 1,079 participants and 4,779 registry encounters were studied. The mean (SD) age of participants at enrollment was 52.9 (13.2) years, 796 (73.8 %) were female, and 167 (15.5 %) reported having an osteopathic physician. The mean physician communication score for osteopathic physicians was 71.2 (95 % CI, 67.6-74.7) vs. 66.2 (95 % CI, 64.8-67.7) for allopathic physicians (p=0.01). The respective mean scores for physician empathy were 41.6 (95 % CI, 39.9-43.2) vs. 38.3 (95 % CI, 37.6-39.1) (p<0.001). There was no significant difference in opioid prescribing for low back pain between osteopathic and allopathic physicians. Although participants treated by osteopathic physicians reported less severe nausea and vomiting as adverse events potentially attributable to opioids in a multivariable model, neither result was clinically relevant. OMC was associated with statistically significant and clinically relevant outcomes pertaining to low back pain intensity, physical function, and health-related quality of life (HRQOL) over 12months. Physician empathy was a significant mediator of OMC treatment effects in each of the three outcome domains; however, physician communication, opioid prescribing, and OMT were not mediators. The study findings indicate that osteopathic physicians provide a patient-centered approach to CLBP treatment, particularly involving empathy, that yields significant and clinically relevant outcomes pertaining to low back pain intensity, physical function, and HRQOL over 12months of follow-up.

Objectives: To review the available evidence on the effectiveness of acupuncture in the treatment of low back pain. Data Sources:MEDLINE, National Guideline Clearinghouse, Guidelines Finder, Cochrane Library, DARE, Bandolier, UpToDate and Index of Portuguese Medical Magazines. Review Methods: Research using the MeSH terms acupuncture and low back pain and the DeCS terms acupuntura e dor lombar. The search was limited to articles published between January 2000 and May 2009 in english, portuguese and spanish. American Family Physicians Strength of Recommendation Taxonomy (SORT) was used to assess the level of evidence. Results: Two meta-analysis, six systematic reviews, three randomised controlled trials and three guidelines met inclusion criteria. Guidelines say that acupuncture might be helpful in the treatment of low back pain. Unspecific chronic low back pain: the meta-analysis, systematic reviews and randomised controlled trials demonstrated that acupuncture is more effective than notreatment and that the association of acupuncture with conventional treatment is more effective than isolated conventional treatment. The studies didnt demonstrate that acupuncture was more effective than placebo or conventional therapies. Acute low back pain: data are inconclusive. Conclusions: Acupuncture is effective in the treatment of unspecific chronic low back pain, isolated or in addition to other interventions (SORT A); it was not proved that acupuncture was superior to other interventions. In the treatment of acute low back pain, there was no evidence of effectiveness of acupuncture. It would be advisable to do high quality, long-term, controlled and randomised studies, addressing its cost-benefit.

Chronic low back pain (CLBP) is common and often managed within multimodal, nonpharmacologic pathways. Clarifying sham-controlled effects of osteopathic manipulative treatment (OMT) can guide early clinical decisions. This study aims to estimate the short-term (≤6weeks) effects of OMT for CLBP, emphasizing sham-controlled comparisons. We preregistered a systematic review and meta-analysis (PROSPERO [Prospective Register of Systematic Reviews] CRD420251154852) and followed PRISMA 2020 (Preferred Reporting Items for Systematic reviews and Meta-Analyses 2020). Randomized trials enrolling adults with CLBP compared OMT with sham/attenuated OMT, usual care, or wait-list. The co-primary outcomes were pain (0-10; mean difference [MD]) and function (Oswestry Disability Index [ODI] or Roland-Morris Disability Questionnaire [RMDQ]; standardized mean difference [SMD]). Analyses were prespecified at end-of-treatment (≤6weeks); the single crossover trial contributed pre-crossover data only. Searches covered MEDLINE (Medical Literature Analysis and Retrieval System Online), Embase (EMBASE [Excerpta Medica dataBASE]), CENTRAL (Cochrane Central Register of Controlled Trials), CINAHL (Cumulative Index of Nursing and Allied Health), and ClinicalTrials.gov through October 2025. Random-effects models (DerSimonian-Laird with Hartung-Knapp) summarized effects with I2 and prediction intervals (PIs); risk of bias (RoB 2) and certainty (GRADE [Grading of Recommendations, Assessment, Development, and Evaluation]) were assessed. Seven trials (n≈378) met the inclusion criteria. Across five trials, OMT reduced pain vs. comparators: MD-1.32 on 0-10 scales (95 % confidence interval [CI],-1.71 to-0.93; I2=6 %; 95 % PI,-2.05 to-0.59). In sham-controlled analyses of function limited to ODI/RMDQ (k=2), OMT improved disability: SMD 1.75 (95 % CI, 1.37 to 2.13; I2=0 %). Adverse events were infrequently reported; where monitored, no serious adverse events were attributed to OMT. Certainty by GRADE was moderate for short-term pain and for sham-controlled function. At≤6weeks, OMT reduces pain and improves function vs. sham without observed serious harms, supporting its use as a low-risk adjunct within guideline-concordant, nonopioid CLBPcare.

The evidence for the efficacy of osteopathic manipulative treatment (OMT) in the management of low back pain (LBP) is considered weak by systematic reviews, because it is generally based on low-quality studies. Consequently, there is a need for more randomized controlled trials (RCTs) with a low risk of bias. The objective of this study is to evaluate the efficacy of an OMT intervention for reducing pain and disability in patients with chronic LBP. A single-blinded, crossover, RCT was conducted at a university-based health system. Participants were adults, 21-65 years old, with nonspecific LBP. Eligible participants (n=80) were randomized to two trial arms: an immediate OMT intervention group and a delayed OMT (waiting period) group. The intervention consisted of three to four OMT sessions over 4-6weeks, after which the participants switched (crossed-over) groups. The primary clinical outcomes were average pain, current pain, Patient-Reported Outcomes Measurement Information System (PROMIS)29 v1.0 pain interference and physical function, and modified Oswestry Disability Index (ODI). Secondary outcomes included the remaining PROMIS health domains and the Fear Avoidance Beliefs Questionnaire (FABQ). These measures were taken at baseline (T0), after one OMT session (T1), at the crossover point (T2), and at the end of the trial (T3). Due to the carryover effects of OMT intervention, only the outcomes obtained prior to T2 were evaluated utilizing mixed-effects models and after adjusting for baseline values. Totals of 35 and 36 participants with chronic LBP were available for the analysis at T1 in the immediate OMT and waiting period groups, respectively, whereas 31 and 33 participants were available for the analysis at T2 in the immediate OMT and waiting period groups, respectively. After one session of OMT (T1), the analysis showed a significant reduction in the secondary outcomes of sleep disturbance and anxiety compared to the waiting period group. Following the entire intervention period (T2), the immediate OMT group demonstrated a significantly better average pain outcome. The effect size was a 0.8 standard deviation (SD), rendering the reduction in pain clinically significant. Further, the improvement in anxiety remained statistically significant. No study-related serious adverse events (AEs) were reported. OMT intervention is safe and effective in reducing pain along with improving sleep and anxiety profiles in patients with chronic LBP.

The role of activity in the therapeutic management of back pain. Report of the International Paris Task Force on Back Pain.

Chronic pain is often present in patients with diabetes mellitus. To assess the effects of osteopathic manual treatment (OMT) in patients with diabetes mellitus and comorbid chronic low back pain (LBP). Randomized, double-blind, sham-controlled, 2×2 factorial trial, including OMT and ultrasound therapy (UST) interventions. University-based study in Dallas-Fort Worth, Texas. A subgroup of 34 patients (7%) with diabetes mellitus within 455 adult patients with nonspecific chronic LBP enrolled in the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial. The Outpatient Osteopathic SOAP Note Form was used to measure somatic dysfunction at baseline. A 100-mm visual analog scale was used to measure LBP severity over 12 weeks from randomization to study exit. Paired serum concentrations of tumor-necrosis factor (TNF)-α obtained at baseline and study exit were available for 6 subgroup patients. Key osteopathic lesions were observed in 27 patients (79%) with diabetes mellitus vs 243 patients (58%) without diabetes mellitus (P=.01). The reduction in LBP severity over 12 weeks was significantly greater in 19 patients with diabetes mellitus who received OMT than in 15 patients with diabetes mellitus who received sham OMT (mean between-group difference in changes in the visual analog scale pain score, -17 mm; 95% confidence interval [CI], -32 mm to -1 mm; P=.04). This difference was clinically relevant (Cohen d=0.7). A corresponding significantly greater reduction in TNF-α serum concentration was noted in patients with diabetes mellitus who received OMT, compared with those who received sham OMT (mean between-group difference, -6.6 pg/mL; 95% CI, -12.4 to -0.8 pg/mL; P=.03). This reduction was also clinically relevant (Cohen d=2.7). No significant changes in LBP severity or TNF-α serum concentration were associated with UST during the 12-week period. Severe somatic dysfunction was present significantly more often in patients with diabetes mellitus than in patients without diabetes mellitus. Patients with diabetes mellitus who received OMT had significant reductions in LBP severity during the 12-week period. Decreased circulating levels of TNF-α may represent a possible mechanism for OMT effects in patients with diabetes mellitus. A larger clinical trial of patients with diabetes mellitus and comorbid chronic LBP is warranted to more definitively assess the efficacy and mechanisms of action of OMT in this population.