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

This study has been completed.
Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Descriptive Information Fields
Brief Title  Physical Therapy Trial for Pelvic Pain
Official Title  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  Interventional
Study Design  Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  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
Secondary Outcome Measure 
Condition  Interstitial Cystitis
Painful Bladder Syndrome
Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Intervention  Procedure: Physical Therapy
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  48
Start Date  November 2006
Completion Date November 2007
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00434343
Organization ID DK65209B
Secondary IDs ††
Study Sponsor  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ††
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    
Information Provided By National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date February 2008
First Received Date  February 12, 2007
Last Updated Date February 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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