NCT00947180|Completed
Gastrointestinal Biopsychosocial Research Center
Randomized Controlled Trial Comparing Biofeedback, Electrogalvanic Stimulation, and Massage for the Treatment of Chronic Proctalgia
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Randomized Controlled Trial Comparing Biofeedback, Electrogalvanic Stimulation, and Massage for the Treatment of Chronic Proctalgia
Sponsor study identifier
Secondary identifiers
NIH
interventional
157
1 country
1
Study Start
October 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2007
Actual (reported)Study Completion
December 2007
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2000
Date type not reportedThis date has not been verified as actual or estimated.
December 2007
Actual (reported)December 2007
Actual (reported)July 22, 2009
Actual (reported)July 27, 2009
Actual (reported)Adequate relief of pain (proctalgia)
1, 3, 6, and 12 months following treatment
Subjective pain improvement (ordinal scale)
1, 3, and 6 months follow-up
Number of days per month with rectal pain (inferred from 30 day symptom diary)
Baseline, then 1, 3, and 6 months follow-up
Visual analog scale rating of pain averaged across weeks for 30 day diary period
Baseline, then 1, 3, and 6 months follow-up
High voltage electrical stimulation was delivered through an anal plug to induce relaxation of pelvic floor muscles.
The therapist massaged the levator ani muscles by applying firm pressure with a gloved finger and rotating from left to right.
Electromyographic (EMG) activity was recorded from a probe in the anal canal, averaged and displayed to patients to help them learn to relax pelvic floor muscles during straining.
Electromyographic (EMG) activity was recorded from sensors placed in the anal canal, averaged, and displayed to patients to help them learn to relax the pelvic floor muscles during straining.
Electrical stimulation was applied to pelvic floor muscles through an anal plug. Frequency was 80 pulses per sec, and voltage was slowly increased from 0 to 150-350 volts as tolerated.
Contact the study team to confirm eligibility.
Division of Gastroenterology at the University of Verona
Verona, Italy
Chiarioni G, Nardo A, Vantini I, Romito A, Whitehead WE. Biofeedback is superior to electrogalvanic stimulation and massage for treatment of levator ani syndrome. Gastroenterology. 2010 Apr;138(4):1321-9. doi: 10.1053/j.gastro.2009.12.040. Epub 2010 Jan 4.
William E Whitehead, PhD
University of North Carolina, Chapel Hill
157 participants (actual enrollment reported by the registry).
First Submitted
July 22, 2009
First Posted
July 27, 2009
Study Start
October 2000
Date type not reportedThis date has not been verified as actual or estimated.
Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia
Using a gloved finger, the therapist pressed on the levator ani as firmly as tolerated and moved the finger from side to side 3-4 times.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Primary Completion
December 2007
Actual (reported)Study Completion
December 2007
Actual (reported)Last Updated
October 18, 2017
Record last verified: 2010-03
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Source: ClinicalTrials.gov.
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