Chronic Pelvic Pain Syndrome, Chronic Prostatitis, Interstitial Cystitis, Painful Bladder Syndrome
Conditions
Keywords
Interstitial Cystitis, Painful Bladder Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome
Brief summary
The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.
Detailed description
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.
Interventions
OTHERGlobal Therapeutic Massage (GTM)
OTHERMyofascial physical therapy (MPT)
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
Sponsors
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number consenting to join study out of eligible patients approached | 6 months | 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). |
| Number of times therapists adhered to prescribed therapeutic protocol | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events reported by the participants | 12 weeks | Number of adverse events reported by the participants |
| Global response assessment (GRA) Global response assessment | 12 weeks | 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 |
| Tolerability of treatment measured by number of treatment sessions participants completed | 12 weeks | Treatment session completion was tracked and used to measure tolerability of treatment. |
Countries
United States
Outcome results
None listed