Comparison of Biofeedback vs. Botox Injection to Treat Levator Ani Syndrome
|ClinicalTrials.gov Identifier: NCT00564707|
Recruitment Status : Unknown
Verified November 2007 by Walter Reed Army Medical Center.
Recruitment status was: Recruiting
First Posted : November 28, 2007
Last Update Posted : November 28, 2007
|First Submitted Date ICMJE||November 26, 2007|
|First Posted Date ICMJE||November 28, 2007|
|Last Update Posted Date||November 28, 2007|
|Start Date ICMJE||August 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Pain reduction from treatment with either Biofeedback, Botox injection, or both [ Time Frame: Two years ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Comparison of Biofeedback vs. Botox Injection to Treat Levator Ani Syndrome|
|Official Title ICMJE||Comparison of Biofeedback Therapy and Botulinum Toxin Type A Injections for Treatment of Painful Levator Ani Syndrome in Women: A Randomized, Prospective Trial|
Purpose: To assess whether EMG directed biofeedback therapy or Botulinum toxin type A injection of the levator ani muscles has any effect on pain from the levator ani syndrome, and, in addition, to what extent either treatment is superior to the other in terms of anorectal physiologic measurements, and quality of life.
Study Design: Randomized, prospective, unblinded double-armed study with crossover.
Methodology: Female subjects, aged 18 and over, with painful levator ani muscle spasm for at least one month duration will be randomized to receive either biofeedback therapy or Botulinum toxin type A injection. After randomization they will all undergo visual analog pain scoring, anorectal manometry, colonoscopy (if clinically indicated), and self-reported SF-36 quality of life measurement. Each patient will also complete numerical pain scale scoring, an SF-36, and a satisfaction questionnaire at each treatment visit and follow-up visit. Patients will submit these by mail. Identification numbers will be assigned to each subject for use on the SF-36 and Satisfaction Questionnaires throughout the study. Subjects will again undergo anorectal manometry at the end of their treatment arms. In the biofeedback arm patients will be treated biweekly for up to eight treatments and be provided exercises to practice at home based on their muscle function noted during the biofeedback training session. Subjects will keep a treatment diary of the exercises they do at home to help ensure compliance with the protocol. In the Botulinum toxin injection arm patients will be treated with scheduled injections of the levator ani muscles every six weeks for up to three total injections of 100U each. These injections will be directed to the painful areas of the levator muscles as guided by physical exam and EMG measurements. Should any patient fail their initial randomized treatment assignment (failure defined as "very dissatisfied" or "dissatisfied" on the satisfaction questionnaire), they will then be allowed to cross over to the other study arm. In addition to numerical pain scale scoring, an SF-36 questionnaire and anorectal manometry will also be repeated at the time of crossover. We intend to include all randomized patients in the final data analysis (according to their originally assigned treatment arm), regardless of outcome or reason for dropout, thus making this an "intent-to-treat" analysis.
Pivotal Study Definitions: The definition of adequate pain reduction, for the purposes of data analysis, will be a reduction in a subject's mean pain score of two on a numerical pain scale (0-10). Failure of either therapy will be defined as a response of "very dissatisfied" or "dissatisfied" on the satisfaction questionnaire at the end of either biofeedback (eight treatment visits) or Botulinum toxin (three injections) both before and after crossover.
Outcomes: We will determine the following for biofeedback therapy and Botulinum toxin type A injection: mean pain reduction, any differences in anorectal physiologic measurements (such as mean resting anal sphincter pressure), any changes in self-reported quality of life, and overall patient satisfaction.
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Levator Ani Syndrome With Pain and/or Constipation Symptoms.|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||84|
|Estimated Completion Date||August 2009|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00564707|
|Other Study ID Numbers ICMJE||07-20034|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Walter Reed Army Medical Center|
|Collaborators ICMJE||Not Provided|
|PRS Account||Walter Reed Army Medical Center|
|Verification Date||November 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP