UPPCRN-RCT#1: Physical Therapy Trial for Pelvic Pain

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Overall Status

Completed

CT.gov ID

NCT00434343

Collaborator

(none)

Enrollment

Locations

Duration (Months)

9.6

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2006

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Medical Center	Stanford	California	United States	94305
2	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611
3	Loyola University Medical Center	Maywood	Illinois	United States	60153
4	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
5	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