Clinical trial NCT00947180: Gastrointestinal Biopsychosocial Research Center
Official title: Randomized Controlled Trial Comparing Biofeedback, Electrogalvanic Stimulation, and Massage for the Treatment of Chronic Proctalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Proctalgia (Also Called Levator Ani Syndrome)
Keywords: Biofeedback
Pelvic floor
Levator ani syndrome
Chronic proctalgia
Electrogalvanic stimulation
Massage
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2009-07-27
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Adequate relief of pain (proctalgia)
timeFrame: 1, 3, 6, and 12 months following treatment
Secondary outcomes:
measure: Subjective pain improvement (ordinal scale)
timeFrame: 1, 3, and 6 months follow-up
measure: Number of days per month with rectal pain (inferred from 30 day symptom diary)
timeFrame: Baseline, then 1, 3, and 6 months follow-up
measure: Visual analog scale rating of pain averaged across weeks for 30 day diary period
timeFrame: Baseline, then 1, 3, and 6 months follow-up
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Division of Gastroenterology at the University of Verona
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: William E Whitehead, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.