Background context: There have been no full-scale trials of the optimal number of visits for the care of any condition with spinal manipulation.
Purpose: To identify the dose-response relationship between visits to a chiropractor for spinal manipulation and chronic low back pain (cLBP) outcomes and to determine the efficacy of manipulation by comparison with a light massage control.
Study design/setting: Practice-based randomized controlled trial.
Patient sample: Four hundred participants with cLBP.
Outcome measures: The primary cLBP outcomes were the 100-point modified Von Korff pain intensity and functional disability scales evaluated at the 12- and 24-week primary end points. Secondary outcomes included days with pain and functional disability, pain unpleasantness, global perceived improvement, medication use, and general health status.
Methods: One hundred participants with cLBP were randomized to each of four dose levels of care: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for 6 weeks. At sessions when manipulation was not assigned, they received a focused light massage control. Covariate-adjusted linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 18, 24, 39, and 52 weeks.
Results: For the primary outcomes, mean pain and disability improvement in the manipulation groups were 20 points by 12 weeks and sustainable to 52 weeks. Linear dose-response effects were small, reaching about two points per six manipulation sessions at 12 and 52 weeks for both variables (p<.025). At 12 weeks, the greatest differences from the no-manipulation control were found for 12 sessions (8.6 pain and 7.6 disability points, p<.025); at 24 weeks, differences were negligible; and at 52 weeks, the greatest group differences were seen for 18 visits (5.9 pain and 8.8 disability points, p<.025).
Conclusions: The number of spinal manipulation visits had modest effects on cLBP outcomes above those of 18 hands-on visits to a chiropractor. Overall, 12 visits yielded the most favorable results but was not well distinguished from other dose levels.
Trial registration: ClinicalTrials.gov NCT00376350.
Keywords: Chiropractic; Chronic low back pain; Dose-response; Randomized controlled trial; Spinal manipulation.
Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.