OBJECTIVE: The aim of the study was to compare the clinical outcomes of 2 approaches to chiropractic care for patients with chronic musculoskeletal pain. Included were the approach most commonly used by doctors of chiropractic (diversified technique spinal manipulation) and a nonmanipulative mind-body approach (Bioenergetic Synchronization Technique). This clinical experiment tested the null hypothesis that there is no clinically or statistically significant difference in effect between the 2 approaches. METHODS: The study was conducted in the research clinic of the Parker College of Chiropractic. Patients were initially recruited by contacting a previously developed pool used for studies related to fall prevention in the elderly. Eighty-one patients (74 females; median age, 66 years) were enrolled and 78 (96%) completed the study. The primary end point was the end of a 3-week nontreatment interval after a 4-week treatment period. An intention-to-treat analysis was used; all patients who completed assessments were included whether or not they were compliant with the treatment protocol. A sample size of 55 per group was estimated to be necessary to detect a clinically significant (6-point) between-group difference in the Pain Disability Index (PDI). The primary outcome, the mean between-group difference between PDI scores at visit 1 and the exit visit, was tested with a 2-tailed t test for independent samples. RESULTS: Mean improvements in the PDI from visit 1 to the exit visit were 6.9 points in the Bioenergetic Synchronization Technique group (n = 40) and 6.4 in the diversified technique group (n = 38); the between-groups difference was not statistically or clinically significant (95% confidence interval, -4.7 to 5.8). CONCLUSIONS: For this particular group of patients, both groups demonstrated similar improvement scores on the PDI; the study's null hypothesis was not rejected.
RCT Entities:
OBJECTIVE: The aim of the study was to compare the clinical outcomes of 2 approaches to chiropractic care for patients with chronic musculoskeletal pain. Included were the approach most commonly used by doctors of chiropractic (diversified technique spinal manipulation) and a nonmanipulative mind-body approach (Bioenergetic Synchronization Technique). This clinical experiment tested the null hypothesis that there is no clinically or statistically significant difference in effect between the 2 approaches. METHODS: The study was conducted in the research clinic of the Parker College of Chiropractic. Patients were initially recruited by contacting a previously developed pool used for studies related to fall prevention in the elderly. Eighty-one patients (74 females; median age, 66 years) were enrolled and 78 (96%) completed the study. The primary end point was the end of a 3-week nontreatment interval after a 4-week treatment period. An intention-to-treat analysis was used; all patients who completed assessments were included whether or not they were compliant with the treatment protocol. A sample size of 55 per group was estimated to be necessary to detect a clinically significant (6-point) between-group difference in the Pain Disability Index (PDI). The primary outcome, the mean between-group difference between PDI scores at visit 1 and the exit visit, was tested with a 2-tailed t test for independent samples. RESULTS: Mean improvements in the PDI from visit 1 to the exit visit were 6.9 points in the Bioenergetic Synchronization Technique group (n = 40) and 6.4 in the diversified technique group (n = 38); the between-groups difference was not statistically or clinically significant (95% confidence interval, -4.7 to 5.8). CONCLUSIONS: For this particular group of patients, both groups demonstrated similar improvement scores on the PDI; the study's null hypothesis was not rejected.