Santilli V, et al. Chiropractic Manipulation in the Treatment of Acute Back Pain and Sciatica with Disc Protrusion: A Randomized Double-Blind Clinical Trial of Active and Simulated Spinal Manipulation. The Spine Journal March-April 2006; 6(2):131-137.
ABSTRACT: Background Context: Acute back pain and sciatica are major sources of disability. many medical interventions are available, including manipulations, with conflicting results. Purpose: To assess the short- and long-term effects of spinal manipulations on acute back pain and sciatica with disc protrusion. Study Design/Setting: Randomized double-blind trial comparing active and simulated manipulations in rehabilitation medical centers in Rome and suburbs. Patient Sample: 102 ambulatory patients with at least moderate pain on a visual analog scale for local pain (VAS1) and/or radiating pain (VAS2). Outcome Measures: Pain-free patients at end of treatment; treatment failure (proportion of patients stopping the assigned treatment for lack of effect on pain); number of days with no, mild, moderate, or severe pain; quality of life; number of days on nonsteroidal anti-inflammatory drugs; number of drug prescriptions; VAS1 and VAS2 scores; quality of life and psychosocial findings; and reduction of disc protrusion on magnetic resonance imaging. Methods: Manipulation or simulated manipulations were done 5 days per week by experienced chiropractors, with a number of sessions which depended on pain relief or up to a maximum of 20, using rapid thrust technique. Patients were assessed at admission and at 15, 30, 45, 90, and 180 days. At each visit, all indicators of pain relief were used. Results: A total of 64 men and 38 women aged 19-63 years were randomized to manipulations (53) or simulated manipulations (49). Manipulations appeared more effective on the basis of the percentage of pain-free cases (local pain 28 vs. 6%; p<.005; radiating pain 55 vs. 20%; p<.0001), number of days with pain (23.6 vs. 27.4; p<.0005), and number of days with moderate or severe pain (13.9 vs. 17.9; p<.05). Patients receiving manipulations had lower mean VAS1 (p<.0001) and VAS2 (p<.001). A significant interaction was found between therapeutic arm and time. There were no significant differences in quality of life and psychosocial scores.
There were only two treatment failures (manipulation 1; simulated manipulation 1) and no adverse events. Conclusions: Active manipulations have more effect than simulated manipulations on pain relief for acute back pain and sciatica with disc protrusion.
COMMENTS: Although the three study authors are Italian MDs, the chiropractic care was provided by two U.S.-trained chiropractors who worked in Italian clinics. From a pool of 485 patients, 102 were chosen and randomized into two groups as noted in the abstract. After 180 days, data was collected on 96. They noted that the active manipulation group had significantly greater relief from both local and radiating acute lower back pain, had fewer days with moderate-to-severe pain, and took fewer pain control drugs. MRI findings were similar from pre- and post-care.