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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Collaborator: |
University of Pennsylvania |
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00733603 |
Purpose
There are many different treatments that doctors recommend for patients with IC/PBS. Only a few research studies have been done to evaluate treatments given to patients. Treatment choices can be of two types: drug therapy and non-drug therapy. The two treatments used in this study will be of the non-drug therapy type. One of the treatments being used in this study is called Myofascial Tissue Manipulation. This is a kind of physical therapy that is designed to work on specific muscles and tissue layers in a particular part of the body. In this study, this treatment will focus on the areas around the pelvis and the pelvic floor. The treatment will involve the physical therapist's use of hands and fingers to target specific muscles and tissues located within your pelvis, rectum, and/or vagina (the pelvic floor) as well as muscles and layers of tissue in your abdomen and legs. The other treatment being used in this study is Global Therapeutic Massage. This treatment involves the physical therapist's use of classic Western body massage techniques on the muscles of your arms, legs, hands, neck, shoulders, back, stomach, buttocks, and feet to create an overall feeling of well being.
The purpose of this research study is to find out if Pelvic Physical Therapy is safe and effective on treating symptoms in women with interstitial cystitis as compared to a full body therapeutic massage. This study will also measure the lasting effects of the treatment up to 3 months after your last study treatment.
| Condition | Intervention |
|---|---|
|
Interstitial Cystitis Painful Bladder Syndrome |
Other: Global Therapeutic Massages (GTM) Other: Myofascial Tissue Manipulation (MTM) |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Single-Blinded Randomized Multi-Center Trial to Evaluate the Efficacy and Durability of Myofascial Tissue Manipulation in Women With Interstitial Cystitis/Painful Bladder Syndrome |
| Estimated Enrollment: | 88 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Sham Comparator
Global Therapeutic Massage (GTM)
|
Other: Global Therapeutic Massages (GTM)
Non-specific somatic treatment with full-body Western massage.
|
|
2: Active Comparator
Myofascial Tissue Manipulation (MTM)
|
Other: Myofascial Tissue Manipulation (MTM)
Targeted internal and external Connective Tissue Manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Stanford University Medical center | |
| Stanford, California, United States, 94305 | |
| Univeristy of California San Diego | |
| San Diego, California, United States, 92093 | |
| United States, Illinois | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinic | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Pennsylvania | |
| University of Pennsylvania Health System | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Canada, Ontario | |
| Queen's University | |
| Kingston, Ontario, Canada, K7L2V7 | |
| Study Director: | LeRoy M Nyberg, MD, PhD | NIDDK/NIH |
| Study Chair: | Mary P Fitzgerald, MD | Loyola University |
| Principal Investigator: | Richard Landis, PhD | University of Pennsylvania |
| Principal Investigator: | Robert Mayer, MD | University of Rochester |
| Principal Investigator: | Emily Lukacz, MD | University of California, San Diego |
| Principal Investigator: | Kenneth Peters, MD | William Beaumont Hospital, Royal Oak, MI |
| Principal Investigator: | Toby Chai, MD | University of Maryland |
| Principal Investigator: | Christopher Payne, MD | Stanford University |
| Principal Investigator: | Claire Yang, MD | University of Washington |
| Principal Investigator: | Phillip Hanno, MD | University of Pennsylvania |
| Principal Investigator: | Karl Kreder, MD | University of Iowa |
| Principal Investigator: | David Burks, MD | Henry Ford Hospital, Detroit |
| Principal Investigator: | Curtis Nickel, MD | Queen's University, Ontario, Canada |
| Study Chair: | Harris Foster, MD | Yale University |
More Information
| Responsible Party: | NIDDK ( LeRoy M. Nyberg, MD, PhD ) |
| Study ID Numbers: | ICCRN RCT#3, U01-DK065209 |
| Study First Received: | August 12, 2008 |
| Last Updated: | September 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00733603 History of Changes |
| Health Authority: | United States: NIDDK, NIH; United States: Institutional Review Board; United States: Federal Government; Canada: Research Ethics Board |
|
Interstitial Cystitis IC Painful Bladder Syndrome |
PBS Bladder Pain Pelvic Pain |
|
Cystitis, Interstitial Cystitis Signs and Symptoms Pathologic Processes Disease Urologic Diseases |
Syndrome Nervous System Diseases Urinary Bladder Diseases Neurologic Manifestations Pain |