Edzard Ernst
MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

Osteopathic manipulative treatment for pain and disability in patients with chronic low back pain… Another study of wishful thinking

Published Tuesday 30 January 2024
The objective of this study is to evaluate the efficacy of an OMT intervention for reducing pain and disability in patients with chronic low back pain (LBP). It was designed as a single-blinded, crossover, randomized trial (RCT) and conducted at a university-based health system. Participants were adults, 21–65 years old, with non-specific LBP. Eligible participants (n=80) were randomized to two trial arms:
  • an immediate osteopathic manipulative therapy (OMT) intervention group,
  • a delayed OMT (waiting period) group.

The intervention consisted of three to four OMT sessions over 4–6 weeks, after which the participants switched (crossed-over) groups. The OMT techniques included a mandatory HVLA thrust technique to the lumbar spine region and any (or none) combination of the following four techniques: (i) soft tissue, (ii) muscle energy, (iii) myofascial, and (iv) articulatory. For patients who could not tolerate the HVLA treatment, a physician had to attempt this technique, minimally by attempting to place the patient in the position to perform this maneuver.

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.
The authors concluded that OMT intervention is safe and effective in reducing pain along with improving sleep and anxiety profiles in patients with chronic LBP.The authors stared their abstract by stating that “the evidence for the efficacy of osteopathic manipulative treatment (OMT) in the management of low back pain (LBP) is considered weak … because it is generally based on low-quality studies.” This is undoubtedly true – but why then did they add one more low-quality study?, I ask myself. To mention just some of the most obvious flaws:

  • This study is far too small to allow conclusions about safety.
  • The trial compared OMT with no therapy; it is likely that the observed outcomes have little to do with OMT but are due to a placebo response.
  • The primary outcome measure showed no effect which essentially means that the study finding was that OMT is ineffective.

My conclusion:

a poor study conducted by wishful thinkers.

 

Posted in alternative medicine, alternative therapist, back pain, bias, bogus claims, causation, clinical trial, critical thinking, musculoskeletal problems, osteopathy, pain, pseudo-science, quackery, symptom-relief

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