Osteopathic Manual Treatment and Ultrasound Therapy for Chronic Low Back Pain

A Randomized Controlled Trial

John C. Licciardone, DO, MS, MBA; Dennis E. Minotti, DO; Robert J. Gatchel, PhD; Cathleen M. Kearns, BA; Karan P. Singh, PhD

Disclosures

Ann Fam Med. 2013;11(2):122-129. 

In This Article

Abstract and Introduction

Abstract

Purpose We studied the efficacy of osteopathic manual treatment (OMT) and ultrasound therapy (UST) for chronic low back pain.

Methods 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.

Results 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.

Conclusions 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.

Introduction

Low back pain is primarily responsible for more than 20 million ambulatory medical care visits[1] and $100 billion in costs[2] annually in the United States. When low back pain persists for 3 months, it is considered chronic and may cause progressive physical and psychological effects.[3] Although practice guidelines recommend considering spinal manipulation for chronic or persistent low back pain,[4,5] a Cochrane Collaboration review concluded that spinal manipulation is not more effective than sham interventions for short-term relief of chronic low back pain.[6] The effectiveness of spinal manipulation remains controversial among family physicians.[7] Osteopathic manual treatment (OMT) is delivered by osteopathic physicians in the United States, and by osteopaths in many other nations. No trial of OMT has conclusively found efficacy in relieving low back pain[8–13] or achieved a status of low risk of bias.[6] High-quality trials of ultrasound therapy (UST) are also needed to assess its efficacy compared with sham procedures.[14] The OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial aims to fill these voids by studying OMT and UST for shortterm relief of nonspecific chronic low back pain.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....