Gastrointestinal Biopsychosocial Research Center

NACompletedINTERVENTIONAL
Enrollment

157

Participants

Timeline

Start Date

October 31, 2000

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Chronic Proctalgia (Also Called Levator Ani Syndrome)
Interventions
BEHAVIORAL

Biofeedback

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.

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.

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.

Trial Locations (1)

Unknown

Division of Gastroenterology at the University of Verona, Verona

All Listed Sponsors
collaborator

University of North Carolina, Chapel Hill

OTHER

lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

NCT00947180 - Gastrointestinal Biopsychosocial Research Center | Biotech Hunter | Biotech Hunter