Gastrointestinal Biopsychosocial Research Center

Randomized Controlled Trial Comparing Biofeedback, Electrogalvanic Stimulation, and Massage for the Treatment of Chronic Proctalgia

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.

Study Overview

• Status: Completed
• Conditions: Chronic Proctalgia (Also Called Levator Ani Syndrome)
• Intervention / Treatment: Other: Electrogalvanic stimulation; Behavioral: Digital massage; Behavioral: Biofeedback

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy
    • Division of Gastroenterology at the University of Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adequate relief of pain (proctalgia)	1, 3, 6, and 12 months following treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborators: University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2000
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 24, 2009
• First Posted (Estimate): July 27, 2009

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Biofeedback; Massage; Pelvic floor; Levator ani syndrome; Chronic proctalgia; Electrogalvanic stimulation
• Other Study ID Numbers: R24 DK67674 (completed); R24DK067674 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No