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 manipulations

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: Manipulations 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 a 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