Chronic Proctalgia (Also Called Levator Ani Syndrome) Clinical Trial
Official title:
Randomized Controlled Trial Comparing Biofeedback, Electrogalvanic Stimulation, and Massage for the Treatment of Chronic Proctalgia
| Verified date | March 2010 |
| Source | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 157 |
| Est. completion date | December 2007 |
| Est. primary completion date | December 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Division of Gastroenterology at the University of Verona | Verona |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | University of North Carolina, Chapel Hill |
Italy,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adequate relief of pain (proctalgia) | 1, 3, 6, and 12 months following treatment | ||
| Secondary | Subjective pain improvement (ordinal scale) | 1, 3, and 6 months follow-up | ||
| Secondary | Number of days per month with rectal pain (inferred from 30 day symptom diary) | Baseline, then 1, 3, and 6 months follow-up | ||
| Secondary | Visual analog scale rating of pain averaged across weeks for 30 day diary period | Baseline, then 1, 3, and 6 months follow-up |