Gastrointestinal Biopsychosocial Research Center

National Institutes of Health (NIH)

Status: Completed

Conditions: Chronic Proctalgia (Also Called Levator Ani Syndrome)

Treatments: Other: Electrogalvanic stimulation; Behavioral: Digital massage; Behavioral: Biofeedback

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00947180

R24DK067674 (U.S. NIH Grant/Contract)

R24 DK67674 (completed)

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Recurring episodes of pain or aching in the anal canal or rectum for at least 12 weeks in the previous year. Episodes last at least 20 minutes. Pain must occur at least weekly during a 4-week run-in.

Exclusion Criteria: Other medical or psychiatric diagnoses that could explain recurring rectal pain. Daily use of psychotropic medications. Meets diagnostic criteria for irritable bowel syndrome or functional constipation. Screening studies included physical examination by a gastroenterologist, colonoscopy, pelvic ultrasound, and surgical consult in all patients and referral to a gynecologist or urologist if indicated by history.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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157 participants in 3 patient groups

Electrogalvanic stimulation

Active Comparator group

Description:

High voltage electrical stimulation was delivered through an anal plug to induce relaxation of pelvic floor muscles.

Treatment:

Other: Electrogalvanic stimulation

Digital massage

Active Comparator group

Description:

The therapist massaged the levator ani muscles by applying firm pressure with a gloved finger and rotating from left to right.

Treatment:

Behavioral: Digital massage

Biofeedback

Experimental group

Description:

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.

Treatment:

Behavioral: Biofeedback