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Completed

NCT Number: NCT00947180

Gastrointestinal Biopsychosocial Research Center

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.

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Key information

Conditions

Chronic Proctalgia (Also Called Levator Ani Syndrome) Levator syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Gastroenterology at the University of Verona

Verona, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biofeedback

Behavioral

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.

Electrogalvanic stimulation

Other

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.

Digital massage

Behavioral

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.

Primary outcomes

  1. Adequate relief of pain (proctalgia)

    Time frame: 1, 3, 6, and 12 months following treatment

Secondary outcomes

  1. Subjective pain improvement (ordinal scale)

    Time frame: 1, 3, and 6 months follow-up

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Jul 27, 2009
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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