Clinical Trial: Gastrointestinal Biopsychosocial Research Center
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized Controlled Trial Comparing Biofeedback, Electrogalvanic Stimulation, and Massage for the Treatment of Chronic Proctalgia
Brief Summary:
This study has been completed. The following is a brief description of the aims, methods, and results of the study:
Previous small studies suggest that chronic proctalgia (chronic recurring pain in the anal canal or rectum), which is also called levator ani syndrome, can be treated with biofeedback to teach relaxation of pelvic floor muscles, or electrogalvanic stimulation (electrical stimulation to relax muscles), or massage of pelvic floor muscles. The aim of this study was to compare the effectiveness of these three treatments, to determine how they work physiologically, and to identify which patients are most likely to benefit.
Methods: Subjects had to meet the diagnostic criteria for chronic proctalgia and to report pain at least once a week. They had to also be free of medical or psychiatric disorders that could explain their chronic proctalgia. Patients qualified to enter the study were separated into two groups based on whether they reported tenderness when the examining physician pressed on the levator ani muscles of the pelvic floor. All 157 patients who were enrolled received 9 sessions of psychological counseling plus biofeedback or electrogalvanic stimulation or massage. The results of treatment were assessed at 1, 3, 6, and 12 months after the end of treatment.
Detailed Summary:
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Current Primary Outcome: Adequate relief of pain (proctalgia) [ Time Frame: 1, 3, 6, and 12 months following treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Subjective pain improvement (ordinal scale) [ Time Frame: 1, 3, and 6 months follow-up ]
- Number of days per month with rectal pain (inferred from 30 day symptom diary) [ Time Frame: Baseline, then 1, 3, and 6 months follow-up ]
- Visual analog scale rating of pain averaged across weeks for 30 day diary period [ Time Frame: Baseline, then 1, 3, and 6 months follow-up ]
Original Secondary Outcome: Same as current
Information By: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Dates:
Date Received: July 22, 2009
Date Started: October 2000
Date Completion:
Last Updated: March 17, 2010
Last Verified: March 2010
