Gastrointestinal Biopsychosocial Research Center
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|ClinicalTrials.gov Identifier: NCT00947180|
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : October 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Proctalgia (Also Called Levator Ani Syndrome)||Behavioral: Biofeedback Other: Electrogalvanic stimulation Behavioral: Digital massage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||157 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial Comparing Biofeedback, Electrogalvanic Stimulation, and Massage for the Treatment of Chronic Proctalgia|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
Active Comparator: Electrogalvanic stimulation
High voltage electrical stimulation was delivered through an anal plug to induce relaxation of pelvic floor muscles.
Other: Electrogalvanic stimulation
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.
Active Comparator: Digital massage
The therapist massaged the levator ani muscles by applying firm pressure with a gloved finger and rotating from left to right.
Behavioral: Digital massage
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.
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.
- Adequate relief of pain (proctalgia) [ Time Frame: 1, 3, 6, and 12 months following treatment ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947180
|Division of Gastroenterology at the University of Verona|
|Principal Investigator:||William E Whitehead, PhD||University of North Carolina, Chapel Hill|