Valter Santilli1, Ettore Beghi, Stefano Finucci. 1. Direttore Cattedra Medicina Fisica e Riabilitativa, Università di Roma La Sapienza, P.le Aldo Moro 5, Roma, Rome, 00185, Italy.
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: 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<.005; radiating pain 55 vs. 20%; p<.0001), number of days with pain (23.6 vs. 27.4; p<.005), 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 scores (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.
RCT Entities:
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-freepatients 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<.005; radiating pain 55 vs. 20%; p<.0001), number of days with pain (23.6 vs. 27.4; p<.005), 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 scores (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.
Authors: Elizabeth Anderson-Peacock; Roland Bryans; Normand Danis; Andrea Furlan; Henri Marcoux; Brock Potter; Rick Ruegg; Eleanor White Journal: J Can Chiropr Assoc Date: 2007-03
Authors: Joel E Bialosky; Steven Z George; Maggie E Horn; Donald D Price; Roland Staud; Michael E Robinson Journal: J Pain Date: 2013-10-27 Impact factor: 5.820