Physical Therapy Trial for Pelvic Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.

Detailed Description
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This is a pilot study wherein eligible participants will be randomly assigned to receive either myofascial tissue manipulation or global therapeutic massage. Those receiving myofascial tissue manipulation will have targeted internal and external connective tissue manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen. Those receiving global therapeutic massage will have non-specific somatic treatment with full-body Western massage.

Official Title
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A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes

Conditions
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Interstitial Cystitis, Painful Bladder Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome

Intervention / Treatment
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* Other: Global Therapeutic Massage (GTM)
* Other: Myofascial physical therapy (MPT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female and male patients who have failed to respond to previous therapies for interstitial cystitis/painful bladder syndrome male patients who have failed to respond to previous therapies for chronic prostatitis/chronic pelvic pain syndrome Exclusion Criteria: neurologic disorder affecting bladder bladder cancer, prostate cancer, or urethral cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Global Therapeutic Massage (GTM)<br>Weekly massages consisting of full body Western massage for 1hour. | Other: Global Therapeutic Massage (GTM)<br> <br> |
| Active Comparator: Myofascial physical therapy (MPT)<br>Connective tissue manipulation to all body wall tissues of the abdominal wall, back, buttocks and thighs that clinically were found to contain connective tissue abnormalities and/or myofascial trigger point release to painful myofascial trigger points | Other: Myofascial physical therapy (MPT)<br>* Connective tissue manipulation to all body wall tissues of the abdominal wall, back, buttocks and thighs that clinically were found to contain connective tissue abnormalities and/or myofascial trigger point release to painful myofascial trigger points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number consenting to join study out of eligible patients approached | This study will recruit both female and male patients who have failed to respond to previous therapies for either Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) or male patients who have failed to respond to previous therapies for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS). | 6 months | 
| Number of times therapists adhered to prescribed therapeutic protocol | For each therapy session therapy records are reviewed to determine whether the therapist followed the therapeutic protocol. Each therapy session is scored as adherent or non-adherent and the number of adherent sessions are recorded per participant | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events reported by the participants | Number of adverse events reported by the participants | 12 weeks | 
| Global response assessment (GRA) Global response assessment | The global response assessment consists of the following question: As compared to when you started the study, how would you rate your overall symptoms now? 1. markedly worse, 2. moderately worse, 3. slightly worse, 4. the same, 5. slightly improved, 6. moderately improved, 7. markedly improved | 12 weeks | 
| Tolerability of treatment measured by number of treatment sessions participants completed | Treatment session completion was tracked and used to measure tolerability of treatment. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interstitial Cystitis, Painful Bladder Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome