Osteopathic Manual Treatment vs Kaltenborn-Evjenth Orthopedic Manual Therapy for Chronic Low Back Pain: A Proposal for a Protocol for Randomized Trials

Abstract

Introduction: Numerous modalities of conservative therapeutic interventions are available to achieve the best health benefits in people with Low Back Pain (LBP), e.g., kinesiotherapy, physical therapy, behavior therapy. People with LBP continue to experience pain and disability despite receiving the best evidence based therapy. Osteopathic Manual Therapy (OMT) and Kaltenborn-Evjenth Ortopedic Manual Therapy (KEOMT) are the other options, although their effectiveness remains controversial. The aim of this study is a proposal for a protocol for randomized trials to compare the effectiveness of OMT vs. KEOMT on pain and disability in people suffering from LBP. Methods and analysis: It’s a randomized study with two-arms parallel, designed with concealed allocation, the assessor’s blinding with intention to-treat analysis. It will include 34 people a group with severe disability ranged from 41 to 60% in Oswestry Disability Index (ODI). There will be two groups: a treatment group (OMT) and a comparison group (KEOMT). All the patients in both groups will receive 2 treatments a week for 5 weeks. Each session in both groups will not exceed 30 minutes. During each session OMT and KEOMT techniques will be repeated 3 times. A baseline assessment will be performed pre and post intervention, two days later. The following parameters will be assessed during the evaluations: Numeric Pain Rating Scale – NPRS, ODI. Ethics and dissemination: The trial was approved by the Scientific Research Ethics Committee of University of Warmia and Mazury, Olsztyn, Poland. Registration approval number: 9/2018. Trial registration: The study protocol was prospectively registered in the Chinese Clinical Trial Registry on December 28, 2019 (registration ID: ChiCTR1900028580). Strengths and Limitations of this Study The participants’ random allocation to the experimental and the control groups. The same experienced physiotherapist, blind to the outcome measures, provides the interventions. The same assistant, blind to the group allocation, administrates the outcomes. The same number of the interventions, the compared contact time with the physiotherapist providing the interventions. A short follow-up period and/or a rather small sample size.