Gastrointestinal Biopsychosocial Research Center

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00947180
First received: July 22, 2009
Last updated: March 17, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Chronic Proctalgia (Also Called Levator Ani Syndrome)
Behavioral: Biofeedback
Other: Electrogalvanic stimulation
Behavioral: Digital massage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Biofeedback, Electrogalvanic Stimulation, and Massage for the Treatment of Chronic Proctalgia

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Adequate relief of pain (proctalgia) [ Time Frame: 1, 3, 6, and 12 months following treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective pain improvement (ordinal scale) [ Time Frame: 1, 3, and 6 months follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 157
Study Start Date: October 2000
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947180

Locations
Italy
Division of Gastroenterology at the University of Verona
Verona, Italy
Sponsors and Collaborators
Investigators
Principal Investigator: William E Whitehead, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: William E Whitehead, PhD, University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT00947180     History of Changes
Other Study ID Numbers: R24 DK67674 (completed)
Study First Received: July 22, 2009
Last Updated: March 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Biofeedback
Pelvic floor
Levator ani syndrome
Chronic proctalgia
Electrogalvanic stimulation
Massage

Additional relevant MeSH terms:
Anus Diseases
Pain
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014