The Effects of Osteopathic Manipulative Treatment on Pain and Disability in Patients with Chronic Low Back Pain: A Single-Blinded Randomized Controlled Trial — The International Society for the Study of the Lumbar Spine
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The Effects of Osteopathic Manipulative Treatment on Pain and Disability in Patients with Chronic Low Back Pain: A Single-Blinded Randomized Controlled Trial (#1075)

John M Popovich, Jr. 1 2 , Jacek Cholewicki 1 2 , N Peter Reeves 3 , Lisa A DeStefano 1 2 , Jacob J Rowan 1 2 , Timothy J Francisco 1 , Lawrence L Prokop 2 4 , Mathew A Zatkin 1 2 , Angela S. Lee S Lee 1 2 , Alla Sikorskii 5 , Pramod K Pathak 6 , Jongeun Choi 7 , Radcliffe J Radcliffe 8 , Ahmed Ramadan 9
  1. Osteopathic Manipulative Medicine, Michigan State University, East Lansing, MI, USA
  2. Center for Neuromusculoskeletal Clinical Research (CNCR), College of Osteopathic Medicine, East Lansing, MI, US
  3. Sumaq Life LLC, East Lansing, MI, USA
  4. Physical Medicine and Rehabilitation, Michigan State University, East Lansing, MI, USA
  5. Psychiatry, Michigan State University, East Lansing, MI, US
  6. Statistics and Probability, Michigan State University, East Lansing, MI, US
  7. School of Mechanical Engineering, Yonsei University, Seoul, Republic of Korea
  8. Mechanical Engineering, Michigan State University, East Lansing, MI, US
  9. Biomedical Engineering, University of Minnesota, Minneapolis, MN, US

INTRODUCTION

Several clinical guidelines for the management of patients with chronic low back pain (LBP) include recommendation of spinal manipulative treatment 1 among other interventions. One such intervention is osteopathic manipulative treatment (OMT) that incorporates a number of manual techniques that are delivered by osteopathic physicians. In general, however, the evidence for the efficacy of manipulative treatments as stand-alone interventions is considered weak, 2 and more studies are necessary 3. Therefore, the purpose of this study was to evaluate the efficacy of OMT in reducing pain and disability in patients with chronic LBP using a randomized controlled trial (RCT) experimental design.

METHODS

A single-blinded cross-over RCT was conducted at a single university-based outpatient clinic. Participants were adults, 21 to 65 years old, with nonspecific LBP. Eligible participants (n=80) were randomized to two treatment arms: an immediate treatment group (OMT group) and a delayed treatment group (control group). The intervention consisted of 3-4 OMT sessions over 4-6 weeks, after which the participants switched groups. The primary clinical outcomes were average pain, current pain measured on a 11-point numerical rating scale, PROMIS-29 v1.0 pain interference and physical function, and modified Oswestry Disability Index. The secondary outcomes included Fear Avoidance and PROMIS-29 fatigue, sleep disturbance, depression, anxiety, and satisfaction with participation in social roles. These measures were taken at baseline (T0), after one OMT session (T1), cross-over point (T2), and after cross-over time-point (T3). Because of the carryover effects of OMT intervention, only the outcomes obtained at T2 (prior to cross-over allocation) were evaluated using general linear models and after adjusting for baseline values.

RESULTS

A total of 30 and 31 participants with chronic LBP were available for the analysis at T2 in the OMT and control groups, respectively. There was no significant reduction in the primary outcomes of pain and disability immediately after one session of OMT (T1). However, a significant reduction in average pain was achieved after the entire intervention period (T2) with a mean between-group difference of 1.3 points (95% CI: [-2.23, -0.43]; p=0.004). The effect size was 0.8 standard deviation, rendering the reduction in pain post-intervention clinically meaningful 4. An immediate significant reduction in sleep disturbance and anxiety was seen after one session of OMT (T1) in the OMT group compared to the control group (p<0.001), with anxiety reduction sustained at T2 (p=0.03). No study-related serious adverse events were reported.

DISCUSSION

The results indicate that OMT intervention is safe and effective in reducing pain and anxiety in patients with chronic LBP following 4-6 weeks of treatment. The improvement in anxiety occurred immediately after one OMT session, while the significant reduction in average pain took longer, 3-4 sessions. This is consistent with findings that early-treatment reductions in catastrophizing and pain-related anxiety predict late-treatment improvements in pain severity 5. Based on the demonstrated efficacy and reported cost savings data 6, OMT could be recommended as a treatment option in the management of patients with chronic LBP.

 

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  2. Kreiner DS, Matz P, Bono CM, et al. Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain. Spine J. 2020;20(7):998-1024.
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