Dose-response and Efficacy of Spinal Manipulation for Care of Chronic Low Back Pain: A Randomized Controlled Trial
SOURCE: Spine J. 2014 (Jul 1); 14 (7): 1106–1116
Mitchell Haas, DC, Darcy Vavrek, ND, David Peterson, DC,
Nayak Polissar, PhD, Moni B. Neradilek, MS
Center for Outcomes Studies,
University of Western States,
2700 NE 132nd Ave., Portland, OR 97230, USA.
haasmitch@comcast.net
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.
That’s a very difficult study to design. Since each one of those chronic low back patients might have a different cause of low back pain, it is almost impossible to make a blanket statement about how many visits are necessary for optimal benefit. Chronic low back pain is not a single-cause condition. Perhaps that’s why there have been no full-scale trials for this “problem”. It would be much more beneficial to gather patients who all have exactly the same condition, and then run this study, for example, “Dose-response and Efficacy of Spinal Manipulation for Care of L5 Right Disc Bulge With MRI-Confirmed Pressure on S1 Nerve and Radiculopathy to the Right Leg”. Obviously it would be difficult to gather so many patients with the exact same condition in order to run a trial, which is probably why such a trial hasn’t existed.
This current paper looks to be of minimal value to practitioners, but of extremely great value to insurers who are looking for any excuse to cut short any treatment plans they deem “excessive”.