Mitchell Haas1, Darcy Vavrek2, David Peterson3, Nayak Polissar4, Moni B Neradilek4. 1. Center for Outcomes Studies, University of Western States, 2700 NE 132nd Ave., Portland, OR 97230, USA. Electronic address: haasmitch@comcast.net. 2. Center for Outcomes Studies, University of Western States, 2700 NE 132nd Ave., Portland, OR 97230, USA. 3. Division of Chiropractic Sciences, University of Western States, 2700 NE 132nd Ave., Portland, OR 97230, USA. 4. The Mountain-Whisper-Light Statistics, 1827 23rd Ave. E., Seattle, WA 98122, USA.
Abstract
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.
RCT Entities:
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.
Authors: Daniel C Cherkin; Richard A Deyo; Karen J Sherman; L Gary Hart; Janet H Street; Andrea Hrbek; Roger B Davis; Elaine Cramer; Bruce Milliman; Jennifer Booker; Robert Mootz; James Barassi; Janet R Kahn; Ted J Kaptchuk; David M Eisenberg Journal: J Am Board Fam Pract Date: 2002 Nov-Dec
Authors: James Donovan; J David Cassidy; Carol Cancelliere; Erik Poulsen; Mette Jensen Stochkendahl; Jørgen Kilsgaard; Marc-André Blanchette; Jan Hartvigsen Journal: J Can Chiropr Assoc Date: 2015-03
Authors: Cynthia R Long; Anthony J Lisi; Robert D Vining; Robert B Wallace; Stacie A Salsbury; Zacariah K Shannon; Stephanie Halloran; Amy L Minkalis; Lance Corber; Paul G Shekelle; Erin E Krebs; Thad E Abrams; Jon D Lurie; Christine M Goertz Journal: Pain Med Date: 2020-12-12 Impact factor: 3.750