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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK065209 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Global Therapeutic Massage (GTM) | Placebo Comparator | Weekly massages consisting of full body Western massage for 1hour. |
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| Myofascial physical therapy (MPT) | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Global Therapeutic Massage (GTM) | Other |
| ||
| Myofascial physical therapy (MPT) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Kusek, PhD | National Institute of Diabetes & Digestive & Kidney Diseases/National Institutes of Health | Study Director |
| Leroy Nyberg, PhD, MD | National Institute of Diabetes & Digestive & Kidney Diseases/National Institutes of Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States | ||
| Northwestern University Feinberg School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19535099 | Result | FitzGerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2009 Aug;182(2):570-80. doi: 10.1016/j.juro.2009.04.022. Epub 2009 Jun 17. | |
| 32734597 |
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| Other |
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 |
|
| 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 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Derived |
| Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2. |
| 23234638 | Derived | Fitzgerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2013 Jan;189(1 Suppl):S75-85. doi: 10.1016/j.juro.2012.11.018. |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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