PMID- 38197301 OWN - NLM STAT- In-Process LR - 20240424 IS - 2702-3648 (Electronic) IS - 2702-3648 (Linking) VI - 124 IP - 5 DP - 2024 May 1 TI - The effects of osteopathic manipulative treatment on pain and disability in patients with chronic low back pain: a single-blinded randomized controlled trial. PG - 219-230 LID - 10.1515/jom-2022-0124 [doi] AB - CONTEXT: The evidence for the efficacy of osteopathic manipulative treatment (OMT) in the management of low back pain (LBP) is considered weak by systematic reviews, because it is generally based on low-quality studies. Consequently, there is a need for more randomized controlled trials (RCTs) with a low risk of bias. OBJECTIVES: The objective of this study is to evaluate the efficacy of an OMT intervention for reducing pain and disability in patients with chronic LBP. METHODS: A single-blinded, crossover, RCT was conducted at a university-based health system. Participants were adults, 21-65 years old, with nonspecific LBP. Eligible participants (n=80) were randomized to two trial arms: an immediate OMT intervention group and 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 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 (T(0)), after one OMT session (T(1)), at the crossover point (T(2)), and at the end of the trial (T(3)). Due to the carryover effects of OMT intervention, only the outcomes obtained prior to T(2) were evaluated utilizing mixed-effects models and after adjusting for baseline values. RESULTS: Totals of 35 and 36 participants with chronic LBP were available for the analysis at T(1) in the immediate OMT and waiting period groups, respectively, whereas 31 and 33 participants were available for the analysis at T(2) in the immediate OMT and waiting period groups, respectively. After one session of OMT (T(1)), 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 (T(2)), 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. CONCLUSIONS: OMT intervention is safe and effective in reducing pain along with improving sleep and anxiety profiles in patients with chronic LBP. CI - (c) 2023 the author(s), published by De Gruyter, Berlin/Boston. FAU - Popovich, John M AU - Popovich JM AD - Center for Neuromusculoskeletal Clinical Research, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. AD - Department of Osteopathic Manipulative Medicine, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. FAU - Cholewicki, Jacek AU - Cholewicki J AD - Center for Neuromusculoskeletal Clinical Research, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. AD - Department of Osteopathic Manipulative Medicine, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. FAU - Reeves, N Peter AU - Reeves NP AD - Sumaq Life, LLC, East Lansing, MI, USA. FAU - DeStefano, Lisa A AU - DeStefano LA AD - Center for Neuromusculoskeletal Clinical Research, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. AD - Department of Osteopathic Manipulative Medicine, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. FAU - Rowan, Jacob J AU - Rowan JJ AD - Center for Neuromusculoskeletal Clinical Research, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. AD - Department of Osteopathic Manipulative Medicine, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. FAU - Francisco, Timothy J AU - Francisco TJ AD - Center for Neuromusculoskeletal Clinical Research, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. AD - Department of Osteopathic Manipulative Medicine, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. FAU - Prokop, Lawrence L AU - Prokop LL AD - Center for Neuromusculoskeletal Clinical Research, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. AD - Department of Physical Medicine & Rehabilitation, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. FAU - Zatkin, Mathew A AU - Zatkin MA AD - Center for Neuromusculoskeletal Clinical Research, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. AD - Department of Osteopathic Manipulative Medicine, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. FAU - Lee, Angela S AU - Lee AS AD - Center for Neuromusculoskeletal Clinical Research, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. AD - Department of Osteopathic Manipulative Medicine, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. FAU - Sikorskii, Alla AU - Sikorskii A AD - Department of Psychiatry Osteopathic Medicine, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA. FAU - Pathak, Pramod K AU - Pathak PK AD - Department of Statistics and Probability, College of Natural Science, Michigan State University, East Lansing, MI, USA. FAU - Choi, Jongeun AU - Choi J AD - School of Mechanical Engineering, Yonsei University, Seoul, South Korea. FAU - Radcliffe, Clark J AU - Radcliffe CJ AD - Department of Mechanical Engineering, College of Engineering, Michigan State University, East Lansing, MI, USA. FAU - Ramadan, Ahmed AU - Ramadan A AD - Department of Biomedical Engineering, College of Science and Engineering, University of Minnesota, Minneapolis, MN, USA. LA - eng PT - Journal Article DEP - 20240111 PL - Germany TA - J Osteopath Med JT - Journal of osteopathic medicine JID - 101776472 SB - IM OTO - NOTNLM OT - disability OT - low back pain OT - osteopathic manipulative medicine EDAT- 2024/01/10 06:41 MHDA- 2024/01/10 06:41 CRDT- 2024/01/10 05:42 PHST- 2022/06/16 00:00 [received] PHST- 2023/10/30 00:00 [accepted] PHST- 2024/01/10 06:41 [pubmed] PHST- 2024/01/10 06:41 [medline] PHST- 2024/01/10 05:42 [entrez] AID - jom-2022-0124 [pii] AID - 10.1515/jom-2022-0124 [doi] PST - epublish SO - J Osteopath Med. 2024 Jan 11;124(5):219-230. doi: 10.1515/jom-2022-0124. eCollection 2024 May 1.