Physical Therapy Trial for Pelvic Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

February 12, 2007

Last Updated Date

February 29, 2008

Start Date ^ICMJE

November 2006

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00434343 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Physical Therapy Trial for Pelvic Pain

Official Title ^ICMJE

A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes

Brief Summary

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

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Interstitial Cystitis
Painful Bladder Syndrome
Chronic Prostatitis
Chronic Pelvic Pain Syndrome

Intervention ^ICMJE

Procedure: Physical Therapy

Study Arms / Comparison Groups

Publications *

FitzGerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2009 Aug;182(2):570-80. Epub 2009 Jun 17.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00434343

Responsible Party

Study ID Numbers ^ICMJE

DK65209B

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

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

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP