The Effects of Osteopathic Manipulative Treatment on Pain and Disability in Patients with Chronic Neck Pain: A Single-Blinded Randomized Controlled Trial.

BACKGROUND Neck pain (NP) affects as much as 70% of individuals at some point in their lives. Systematic reviews indicate that manual treatments can be moderately effective in the management of chronic, nonspecific NP. However, there is a paucity of studies specifically evaluating the efficacy of osteopathic manipulative treatment (OMT). OBJECTIVE To evaluate the efficacy of OMT in reducing pain and disability in patients with chronic NP. DESIGN Single-blinded, cross-over, randomized controlled trial. SETTING University-based, osteopathic manipulative medicine outpatient clinic. PARTICIPANTS 97 participants, 21-65 years old, with chronic, nonspecific NP. INTERVENTIONS Participants were randomized to two trial arms: immediate OMT intervention or waiting period first. The intervention consisted of 3-4 OMT sessions over 4-6 weeks, after which the participants switched groups. MAIN OUTCOME MEASURES Primary outcome measures were pain intensity (average and current) on the numerical rating scale and Neck Disability Index. Secondary outcomes included PROMIS-29 health domains and Fear Avoidance Beliefs Questionnaire. Outcomes obtained prior to the cross-over allocation were evaluated using general linear models and after adjusting for baseline values. RESULTS 38 and 37 participants were available for the analysis in the OMT and waiting period groups, respectively. The results showed significantly better primary outcomes in the immediate OMT group for reductions in average pain (-1.02, 95%CI:[-1.72, -0.32], P = 0.005), current pain (-1.02, 95%CI:[-1.75, -0.30], P = 0.006), disability (-5.30%, 95%CI:[-9.2%, -1.3%], P = 0.010) and improved secondary outcomes (PROMIS) related to sleep (-3.25, 95%CI: [-6.95, -1.54], P = 0.003), fatigue (-3.26, 95%CI:[-6.04, -0.48], P = 0.022), and depression (-2.59, 95%CI:[-4.73, -0.45], P = 0.018). The effect sizes were in the clinically meaningful range between 0.5 and 1 SD. No study-related serious adverse events were reported. CONCLUSIONS OMT is relatively safe and effective in reducing pain and disability along with improving sleep, fatigue, and depression in patients with chronic NP immediately following treatment delivered over approximately 4-6 weeks. TRIAL REGISTRATION ClinicalTrials.gov NCT# 02261259. This article is protected by copyright. All rights reserved.