Comparison of Biofeedback vs. Botox Injection to Treat Levator Ani Syndrome
Recruitment status was: Recruiting
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.
|Levator Ani Syndrome With Pain and/or Constipation Symptoms.||Behavioral: Biofeedback therapy Procedure: Botulinum Toxin Type A Injection|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Biofeedback Therapy and Botulinum Toxin Type A Injections for Treatment of Painful Levator Ani Syndrome in Women: A Randomized, Prospective Trial|
- Pain reduction from treatment with either Biofeedback, Botox injection, or both [ Time Frame: Two years ]
- Anorectal physiologic changes - increase or decrease in anal sphincter pressures [ Time Frame: Two years ]
- Overall patient satisfaction [ Time Frame: Two years ]
- Patient quality of life [ Time Frame: Two years ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||August 2009|
Active Comparator: 1
Standard biofeedback therapy will be given for painful levator ani syndrome over a course of eight weeks.
Behavioral: Biofeedback therapy
EMG guided biofeedback therapy using standard biofeedback computer software
Active Comparator: 2
Botulinum toxin type A will be injected under EMG guidance into spastic and painful levator ani muscles. This may be repeated only twice on separate visits.
Procedure: Botulinum Toxin Type A Injection
Under EMG guidance Botox is injected directly into the painful levator ani muscle.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564707
|Contact: Jeffery M Nelson, MD||202-782-9691||Jeffery.Nelson@us.army.mil|
|Contact: Todd Albright, MD||202-782-8518||Todd.Albright@na.amedd.army.mil|
|United States, District of Columbia|
|Walter Reed Army Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20307|
|Principal Investigator: Jeffery M Nelson, MD|
|Sub-Investigator: Todd S Albright, MD|
|Sub-Investigator: Kendra L Harrington, DPT|
|Principal Investigator:||Jeffery M Nelson, MD||Walter Reed Army Medical Center|