Gastrointestinal Biopsychosocial Research Center

Not Applicable

Completed

• Conditions: Chronic Proctalgia (Also Called Levator Ani Syndrome)
• Interventions: Other: Electrogalvanic stimulation; Behavioral: Digital massage; Behavioral: Biofeedback

• Registration Number: NCT00947180
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 Description

Not available

Study Timeline

• Study Start: 2000-10
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Status Verified: 2010-03
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrogalvanic stimulation	Electrogalvanic stimulation	High voltage electrical stimulation was delivered through an anal plug to induce relaxation of pelvic floor muscles.
Digital massage	Digital massage	The therapist massaged the levator ani muscles by applying firm pressure with a gloved finger and rotating from left to right.
Biofeedback	Biofeedback	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.

Primary Outcome Measures

Name	Time	Method
Adequate relief of pain (proctalgia)	1, 3, 6, and 12 months following treatment

Secondary Outcome Measures

Name	Time	Method
Subjective pain improvement (ordinal scale)	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
Number of days per month with rectal pain (inferred from 30 day symptom diary)	Baseline, then 1, 3, and 6 months follow-up

Trial Locations

Locations (1)

Division of Gastroenterology at the University of Verona; 🇮🇹 Verona, Italy