Osteopathic Manual Treatment and Ultrasound Therapy for Chronic Low Back Pain: A Randomized Controlled Trial

The Osteopathic Research Center, University of North Texas Health Science Center, Fort Worth, Texas.
The Annals of Family Medicine (Impact Factor: 5.43). 03/2013; 11(2):122-129. DOI: 10.1370/afm.1468
Source: PubMed


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.

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Available from: Cathleen M Kearns, Jul 13, 2015
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    • "Other subgroups that consistently exhibited large RRs for stable clinical response and clinical response at the week 12 exit visit, coupled with small RRs for relapse, included those in the 21e39 year age category; current cigarette smokers; and patients with LBP duration greater than one year, greater deficits in back-specific functioning , and poorer general health. Although OMT was associated with decreased need of prescription rescue mediation (RR, 0.66; 95% CI, 0.43e1.00) in the originally reported outcomes of the OSTEOPATHIC Trial (Licciardone et al., 2013b), our present findings suggest that patients who concurrently use non-prescription medication for LBP may experience an enhanced response to OMT and decreased likelihood of relapse. It is interesting to review potential mechanisms by which OMT may exert its treatment effects in light of our subgroup findings. "
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    ABSTRACT: Clinical response and relapse following a regimen of osteopathic manual treatment (OMT) were assessed in patients with chronic low back pain (LBP) within the OSTEOPATHIC Trial, a randomized, double-blind, sham-controlled study. Initial clinical response and subsequent stability of response, including final response and relapse status at week 12, were determined in 186 patients with high baseline pain severity (≥50 mm on a 100-mm visual analogue scale). Substantial improvement in LBP, defined as 50% or greater pain reduction relative to baseline, was used to assess clinical response at weeks 1, 2, 4, 6, 8, and 12. Sixty-two (65%) patients in the OMT group attained an initial clinical response vs. 41 (45%) patients in the sham OMT group (risk ratio [RR], 1.45; 95% confidence interval [CI], 1.11-1.90). The median time to initial clinical response to OMT in these patients was 4 weeks. Among patients with an initial clinical response prior to week 12, 13 (24%) patients in the OMT group vs. 18 (51%) patients in the sham OMT group relapsed (RR, 0.47; 95% CI, 0.26-0.83). Overall, 49 (52%) patients in the OMT group attained or maintained a clinical response at week 12 vs. 23 (25%) patients in the sham OMT group (RR, 2.04; 95% CI, 1.36-3.05). The large effect size for short-term efficacy of OMT was driven by stable responders who did not relapse.
    Preview · Article · Dec 2014 · Manual Therapy
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    • "Ten studies with 12 comparison groups and 1141 participants were analysed for the effect of OMT for pain in acute and chronic LBP. Six studies reported a significant effect on pain in favour of OMT [39, 42, 46, 50, 52, 56], 3 studies reported a non-significant effect in favour of OMT [40, 41, 51], and 3 studies reported a non-significant effect in favour of the control treatment [41, 47, 51]. For pain, there was moderate-quality evidence (downgraded due to inconsistency) that OMT had a significant effect on pain relief (MD, -12.91; 95% CI, -20.00 to -5.82) (Figure  2 and Table  5). "
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    ABSTRACT: Objectives: Nonspecific neck pain is common, disabling, and costly. The objective of the current review was to assess the effectiveness of osteopathic manipulative treatment (OMT) in the management of chronic nonspecific neck pain regarding pain, functional status, and adverse events. Study selection: A systematic literature search unrestricted by language was performed in March 2014 in several electronic databases and in databases of ongoing trials. A manual search of reference lists and personal communication with experts identified additional studies. Only randomized clinical trials were included, and studies of specific neck pain or single treatment techniques were excluded. Primary outcomes were pain and functional status, and secondary outcome was adverse events. Data extraction: Studies were independently reviewed using a standardized data extraction form. Mean difference (MD) or standard mean difference (SMD) with 95% confidence intervals (CIs) and overall effect size were calculated for primary outcomes. GRADE was used to assess quality of the evidence. Data synthesis: Of 299 identified studies, 18 were evaluated and 15 excluded. The 3 reviewed studies had low risk of bias. Moderate-quality evidence suggested OMT had a significant and clinically relevant effect on pain relief (MD: -13.04, 95% CI: -20.64 to -5.44) in chronic nonspecific neck pain, and moderate-quality evidence suggested a non-significant difference in favour of OMT for functional status (SMD: -0.38, 95% CI: -0.88 to 0.11). No serious adverse events were reported. Conclusion: Based on the 3 included studies, the review suggested clinically relevant effects of OMT for reducing pain in patients with chronic nonspecific neck pain. Given the small sample sizes, different comparison groups, and lack of long-term measurements in the few available studies, larger, high-quality randomized controlled trials with robust comparison groups are recommended.
    Full-text · Article · Aug 2014 · BMC Musculoskeletal Disorders
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    • "This cohort consisted of 115 patients who received active OMT and active ultrasound therapy , and another 115 patients who received active OMT and sham ultrasound therapy. Active ultrasound therapy was not efficacious when compared with sham ultrasound therapy in providing improvements in LBP or secondary outcomes (Licciardone et al., 2013c). "
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    ABSTRACT: The purpose of this study was to measure changes in biomechanical dysfunction following osteopathic manual treatment (OMT) and to assess how such changes predict subsequent low back pain (LBP) outcomes. Secondary analyses were performed with data collected during the OSTEOPATHIC Trial wherein a randomized, double-blind, sham-controlled, 2x2 factorial design was used to study OMT for chronic LBP. At baseline, prevalence rates of non-neutral lumbar dysfunction, pubic shear, innominate shear, restricted sacral nutation, and psoas syndrome were determined in 230 patients who received OMT. Five OMT sessions were provided at weeks 0, 1, 2, 4, and 6, and the prevalence of each biomechanical dysfunction was again measured at week 8 immediately before the final OMT session. Moderate pain improvement (≥30% reduction on a 100-mm visual analogue scale) at week 12 defined a successful LBP response to treatment. Prevalence rates at baseline were: non-neutral lumbar dysfunction, 124 (54%); pubic shear, 191 (83%); innominate shear, 69 (30%); restricted sacral nutation, 87 (38%), and psoas syndrome, 117 (51%). Significant improvements in each biomechanical dysfunction were observed with OMT; however, only psoas syndrome remission occurred more frequently in LBP responders than non-responders (P for interaction=0.002). Remission of psoas syndrome was the only change in biomechanical dysfunction that predicted subsequent LBP response after controlling for the other biomechanical dysfunctions and potential confounders (odds ratio, 5.11; 95% confidence interval, 1.54-16.96). These findings suggest that remission of psoas syndrome may be an important and previously unrecognized mechanism explaining clinical improvement in patients with chronic LBP following OMT.
    Full-text · Article · Aug 2014 · Manual therapy
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