Physical Therapy Trial for Pelvic Pain - Full Text View

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

This study has been completed.

First Received: February 12, 2007 Last Updated: February 29, 2008 History of Changes

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00434343

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

MedlinePlus related topics: Interstitial Cystitis Pelvic Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes

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
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
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

Study ID Numbers:	DK65209B
Study First Received:	February 12, 2007
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00434343 History of Changes
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

Study placed in the following topic categories:

Cystocele
Prostatic Diseases
Urinary Bladder Diseases
Cystitis
Pain
Genital Diseases, Male
Prostatitis

Signs and Symptoms
Cystitis, Interstitial
Pelvic Pain
Urologic Diseases
Mental Disorders
Chronic Disease
Somatoform Disorders

Additional relevant MeSH terms:

Disease Attributes
Disease
Prostatic Diseases
Urinary Bladder Diseases
Cystitis
Pain
Genital Diseases, Male
Prostatitis
Signs and Symptoms

Cystitis, Interstitial
Pathologic Processes
Pelvic Pain
Urologic Diseases
Mental Disorders
Syndrome
Chronic Disease
Somatoform Disorders

ClinicalTrials.gov processed this record on May 07, 2009