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Physical Therapy Trial for Pelvic Pain (UPPCRN-RCT#1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00434343
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : December 12, 2022
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Painful Bladder Syndrome Chronic Prostatitis Chronic Pelvic Pain Syndrome Other: Global Therapeutic Massage (GTM) Other: Myofascial physical therapy (MPT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
Study Start Date : November 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Global Therapeutic Massage (GTM)
Weekly massages consisting of full body Western massage for 1hour.
Other: Global Therapeutic Massage (GTM)
Active Comparator: Myofascial 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
Other: Myofascial 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




Primary Outcome Measures :
  1. Number consenting to join study out of eligible patients approached [ Time Frame: 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).

  2. Number of times therapists adhered to prescribed therapeutic protocol [ Time Frame: 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 Outcome Measures :
  1. Number of adverse events reported by the participants [ Time Frame: 12 weeks ]
    Number of adverse events reported by the participants

  2. Global response assessment (GRA) Global response assessment [ Time Frame: 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

  3. Tolerability of treatment measured by number of treatment sessions participants completed [ Time Frame: 12 weeks ]
    Treatment session completion was tracked and used to measure tolerability of treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434343


Locations
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United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pennsylvania
Investigators
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Study Director: 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
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00434343    
Other Study ID Numbers: UPPCRN RCT1 - PT
U01DK065209 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Interstitial Cystitis
Painful Bladder Syndrome
Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Prostatitis
Syndrome
Pelvic Pain
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Prostatic Diseases