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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 : March 3, 2010
Sponsor:
Information provided by:
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 Procedure: Physical Therapy 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)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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





Primary Outcome Measures :
  1. number consenting to join study out of eligible patients approached
  2. number thought eligible by physician deemed ineligible by PT
  3. adherence to prescribed therapeutic protocol
  4. adverse events
  5. tolerability of treatment as rated by patient
  6. global response assessment


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)
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00434343    
Other Study ID Numbers: DK65209B (IND)
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: March 3, 2010
Last Verified: March 2010
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