Chronic Proctalgia (Also Called Levator Ani Syndrome)NCT00947180
Gastrointestinal Biopsychosocial Research Center
A study testing Biofeedback, Electrogalvanic stimulation and Digital massage in people with Chronic Proctalgia (Also Called Levator Ani Syndrome), run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Proctalgia (Also Called Levator Ani Syndrome)
- What is being tested?
- Biofeedback, Electrogalvanic stimulation and Digital massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2000to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Biofeedback, Electrogalvanic stimulation, Digital massage
- Keywords
- Biofeedback, Pelvic floor, Levator ani syndrome, Chronic proctalgia, Electrogalvanic stimulation, Massage
- Medical subject headings
- Levator syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
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 stimulationOther
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 massageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrogalvanic stimulation | Active comparator | High voltage electrical stimulation was delivered through an anal plug to induce relaxation of pelvic floor muscles. Receives: Other: Electrogalvanic stimulation |
| Digital massage | Active comparator | The therapist massaged the levator ani muscles by applying firm pressure with a gloved finger and rotating from left to right. Receives: Behavioral: Digital massage |
| Biofeedback | Experimental | 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. Receives: Behavioral: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate relief of pain (proctalgia)
Measured: 1, 3, 6, and 12 months following treatment
Secondary outcomes (3)
Subjective pain improvement (ordinal scale)
Measured: 1, 3, and 6 months follow-up
Number of days per month with rectal pain (inferred from 30 day symptom diary)
Measured: Baseline, then 1, 3, and 6 months follow-up
Visual analog scale rating of pain averaged across weeks for 30 day diary period
Measured: Baseline, then 1, 3, and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startOct 2000
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Proctalgia (Also Called Levator Ani Syndrome)Studies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- William E Whitehead, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947180
- Sponsor's protocol ID
- R24 DK67674 (completed)
- Other IDs
- R24DK067674
- Status last verified
- Mar 2010
- First submitted
- 22 Jul 2009
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 20044997
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Biofeedback, Electrogalvanic Stimulation, and Massage for the Treatment of Chronic Proctalgia
- ClinicalTrials.gov ID
- NCT00947180
- Acronym / sponsor ID
- R24 DK67674 (completed)
- Keywords
- Biofeedback, Pelvic floor, Levator ani syndrome, Chronic proctalgia, Electrogalvanic stimulation, Massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- Oct 2000
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electrogalvanic stimulation | Active comparator | Other: Electrogalvanic stimulationHigh voltage electrical stimulation was delivered through an anal plug to induce relaxation of pelvic floor muscles. |
| Digital massage | Active comparator | Behavioral: Digital massageThe therapist massaged the levator ani muscles by applying firm pressure with a gloved finger and rotating from left to right. |
| Biofeedback | Experimental | Behavioral: BiofeedbackElectromyographic (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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofeedbackElectromyographic (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. | Behavioural | Biofeedback |
| Electrogalvanic stimulationElectrical 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. | Other | Electrogalvanic stimulation |
| Digital massageUsing 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. | Behavioural | Digital massage |
Primary outcome
Adequate relief of pain (proctalgia)
Time frame: 1, 3, 6, and 12 months following treatment
3 secondary outcomes
Subjective pain improvement (ordinal scale)
Time frame: 1, 3, and 6 months follow-up
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Results publication: PubMed 20044997Chiarioni 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William E Whitehead, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback, Electrogalvanic stimulation and Digital massage in people with Chronic Proctalgia (Also Called Levator Ani Syndrome), run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate relief of pain (proctalgia) (time frame: 1, 3, 6, and 12 months following treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00947180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.