Physical Therapy Trial for Pelvic Pain - Full Text View

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 Prostate Diseases

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

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

Pregnancy Complications

Prostatic Diseases

Urinary Bladder Diseases

Cystitis

Pain

Genital Diseases, Male

Prostatitis

Signs and Symptoms

Cystitis, Interstitial

Pathologic Processes

Pelvic Pain

Urologic Diseases

Chronic Disease

Somatoform Disorders

Additional relevant MeSH terms:

Disease Attributes

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Female Urogenital Diseases

Mental Disorders

Pathological Conditions, Signs and Symptoms

ClinicalTrials.gov processed this record on May 08, 2008

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