Lizhou Liu1, Margot A Skinner1, Suzanne M McDonough2, G David Baxter1. 1. 1 Centre for Health, Activity, and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand. 2. 2 Centre for Health and Rehabilitation Technologies, Institute of Nursing & Health Research, School of Health Sciences, Ulster University, Belfast, UK.
Abstract
OBJECTIVE: To evaluate the feasibility of a randomized controlled trial investigating the optimal number of treatment sessions of acupuncture, used as an adjunct to usual care, for managing chronic low back pain. METHODS: In total, 45 participants with chronic low back pain were recruited and randomly allocated to receive usual care plus 4, 7, or 10 sessions of acupuncture (15/group). Primary outcomes were recruitment rate, randomization rate, treatment compliance, completion of the outcome measures, and retention rates. Secondary outcomes included back function, pain intensity and bothersomeness, generic health status, activity disability, and participant satisfaction. Data were collected at baseline and discharge, and at 6 and 12 weeks post randomization. RESULTS: The recruitment method was demonstrated to be successful: recruitment rate was 43.7%, and randomization rate was 100%. Compliance with treatment was high among participants (86.7%, 86.7%, and 100% for the 4-, 7-, and 10-session group, respectively). Outcome questionnaires used in this study were found to be appropriate for a future randomized controlled trial. Participant retention rates were 88.9% at discharge and at 6 weeks post randomization and 84.4% at 12 weeks post randomization. Secondary outcomes (except for pain intensity) favored the 10-session acupuncture group at 12 weeks post randomization. Over 90% of participants indicated that they were "very satisfied" and/or "extremely satisfied" with the acupuncture treatment. CONCLUSION: This study demonstrated that a full-scale randomized controlled trial using the methodology described above is feasible, and such a trial is essential to test the dose dependence of acupuncture.
RCT Entities:
OBJECTIVE: To evaluate the feasibility of a randomized controlled trial investigating the optimal number of treatment sessions of acupuncture, used as an adjunct to usual care, for managing chronic low back pain. METHODS: In total, 45 participants with chronic low back pain were recruited and randomly allocated to receive usual care plus 4, 7, or 10 sessions of acupuncture (15/group). Primary outcomes were recruitment rate, randomization rate, treatment compliance, completion of the outcome measures, and retention rates. Secondary outcomes included back function, pain intensity and bothersomeness, generic health status, activity disability, and participant satisfaction. Data were collected at baseline and discharge, and at 6 and 12 weeks post randomization. RESULTS: The recruitment method was demonstrated to be successful: recruitment rate was 43.7%, and randomization rate was 100%. Compliance with treatment was high among participants (86.7%, 86.7%, and 100% for the 4-, 7-, and 10-session group, respectively). Outcome questionnaires used in this study were found to be appropriate for a future randomized controlled trial. Participant retention rates were 88.9% at discharge and at 6 weeks post randomization and 84.4% at 12 weeks post randomization. Secondary outcomes (except for pain intensity) favored the 10-session acupuncture group at 12 weeks post randomization. Over 90% of participants indicated that they were "very satisfied" and/or "extremely satisfied" with the acupuncture treatment. CONCLUSION: This study demonstrated that a full-scale randomized controlled trial using the methodology described above is feasible, and such a trial is essential to test the dose dependence of acupuncture.
Authors: Arya Nielsen; Laura Ocker; Iman Majd; Jeff A Draisin; Katherine Taromina; Marjorie T Maggenti; Jaimie Long; Mark Nolting; Karen J Sherman Journal: Glob Adv Health Med Date: 2021-05-26