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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00434343
First received: February 12, 2007
Last updated: March 2, 2010
Last verified: March 2010
History of Changes
  Purpose

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


Condition Intervention
Interstitial Cystitis
Painful Bladder Syndrome
Chronic Prostatitis
Chronic Pelvic Pain Syndrome
 Procedure: Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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

Estimated Enrollment: 48
Study Start Date: November 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434343

Locations
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
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
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00434343     History of Changes
Other Study ID Numbers: DK65209B (IND)
Study First Received: February 12, 2007
Last Updated: March 2, 2010
Health Authority: United States: Federal Government

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:
Cystitis
Pain
Pelvic Pain
Prostatitis
Chronic Disease
Cystitis, Interstitial
Somatoform Disorders
Urinary Bladder Diseases
Urologic Diseases
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease Attributes
Pathologic Processes
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013