J Y Maigne1, G Chatellier. 1. Department of Physical Medicine, Hotel-Dieu University Hospital, Paris, France. jy.maigne@htd.ap-hop-paris.fr
Abstract
STUDY DESIGN: A prospective pilot study with independent assessment and a 2-year follow-up period was conducted. OBJECTIVES: To compare and assess the efficacy of three manual coccydynia treatments, and to identify factors predictive of a good outcome. SUMMARY OF BACKGROUND DATA: Various manual medicine treatments have been described in the literature. In an open study, the addition of manipulation to injection treatment produced a 25% increase in satisfactory results. Dynamic radiographs of the coccyx allow breakdown of coccydynia into four etiologic groups based on coccygeal mobility: luxation, hypermobility, immobility, and normal mobility. These groups may respond differently to manual treatments. METHODS: The patients were randomized into three groups, each of which received three to four sessions of a different treatment: levator anus massage, joint mobilization, or mild levator stretch. Assessment with a visual analog scale was performed by an independent observer at 7 days, 30 days, 6 months, and 2 years. RESULTS: The results of the manual treatments were satisfactory for 25.7% of the cases at 6 months, and for 24.3% of the cases at 2 years. The results varied with the cause of the coccydynia. The patients with an immobile coccyx had the poorest results, whereas those with a normally mobile coccyx fared the best. The patients with luxation or hypermobility had results somewhere between these two rates. Levator anus massage and stretch were more effective than joint mobilization, which worked only for patients with a normally mobile coccyx. Pain when patients stood up from sitting and excessive levator tone were associated with a good outcome. However, none of the results was significant because of the low success rate associated with manual treatment. CONCLUSIONS: There is a need for a placebo-controlled study to establish conclusively whether manual treatments are effective. This placebo must be an external treatment. A sample size of 190 patients would be required for 80% confidence in detecting a difference.
RCT Entities:
STUDY DESIGN: A prospective pilot study with independent assessment and a 2-year follow-up period was conducted. OBJECTIVES: To compare and assess the efficacy of three manual coccydynia treatments, and to identify factors predictive of a good outcome. SUMMARY OF BACKGROUND DATA: Various manual medicine treatments have been described in the literature. In an open study, the addition of manipulation to injection treatment produced a 25% increase in satisfactory results. Dynamic radiographs of the coccyx allow breakdown of coccydynia into four etiologic groups based on coccygeal mobility: luxation, hypermobility, immobility, and normal mobility. These groups may respond differently to manual treatments. METHODS: The patients were randomized into three groups, each of which received three to four sessions of a different treatment: levator anus massage, joint mobilization, or mild levator stretch. Assessment with a visual analog scale was performed by an independent observer at 7 days, 30 days, 6 months, and 2 years. RESULTS: The results of the manual treatments were satisfactory for 25.7% of the cases at 6 months, and for 24.3% of the cases at 2 years. The results varied with the cause of the coccydynia. The patients with an immobile coccyx had the poorest results, whereas those with a normally mobile coccyx fared the best. The patients with luxation or hypermobility had results somewhere between these two rates. Levator anus massage and stretch were more effective than joint mobilization, which worked only for patients with a normally mobile coccyx. Pain when patients stood up from sitting and excessive levator tone were associated with a good outcome. However, none of the results was significant because of the low success rate associated with manual treatment. CONCLUSIONS: There is a need for a placebo-controlled study to establish conclusively whether manual treatments are effective. This placebo must be an external treatment. A sample size of 190 patients would be required for 80% confidence in detecting a difference.