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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00434343
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : December 12, 2022
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date  ICMJE February 12, 2007
First Posted Date  ICMJE February 13, 2007
Last Update Posted Date December 12, 2022
Study Start Date  ICMJE November 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2022)
  • Number consenting to join study out of eligible patients approached [ Time Frame: 6 months ]
    This study will recruit both female and male patients who have failed to respond to previous therapies for either Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) or male patients who have failed to respond to previous therapies for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS).
  • Number of times therapists adhered to prescribed therapeutic protocol [ Time Frame: 12 weeks ]
    For each therapy session therapy records are reviewed to determine whether the therapist followed the therapeutic protocol. Each therapy session is scored as adherent or non-adherent and the number of adherent sessions are recorded per participant
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2007)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2022)
  • Number of adverse events reported by the participants [ Time Frame: 12 weeks ]
    Number of adverse events reported by the participants
  • Global response assessment (GRA) Global response assessment [ Time Frame: 12 weeks ]
    The global response assessment consists of the following question: "As compared to when you started the study, how would you rate your overall symptoms now?" 1. markedly worse, 2. moderately worse, 3. slightly worse, 4. the same, 5. slightly improved, 6. moderately improved, 7. markedly improved
  • Tolerability of treatment measured by number of treatment sessions participants completed [ Time Frame: 12 weeks ]
    Treatment session completion was tracked and used to measure tolerability of treatment.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Interstitial Cystitis
  • Painful Bladder Syndrome
  • Chronic Prostatitis
  • Chronic Pelvic Pain Syndrome
Intervention  ICMJE
  • Other: Global Therapeutic Massage (GTM)
  • Other: Myofascial physical therapy (MPT)
    Connective tissue manipulation to all body wall tissues of the abdominal wall, back, buttocks and thighs that clinically were found to contain connective tissue abnormalities and/or myofascial trigger point release to painful myofascial trigger points
Study Arms  ICMJE
  • Placebo Comparator: Global Therapeutic Massage (GTM)
    Weekly massages consisting of full body Western massage for 1hour.
    Intervention: Other: Global Therapeutic Massage (GTM)
  • Active Comparator: Myofascial physical therapy (MPT)
    Connective tissue manipulation to all body wall tissues of the abdominal wall, back, buttocks and thighs that clinically were found to contain connective tissue abnormalities and/or myofascial trigger point release to painful myofascial trigger points
    Intervention: Other: Myofascial physical therapy (MPT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2022)
47
Original Enrollment  ICMJE
 (submitted: February 12, 2007)
48
Actual Study Completion Date  ICMJE November 2007
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00434343
Other Study ID Numbers  ICMJE UPPCRN RCT1 - PT
U01DK065209 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Pennsylvania
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
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date December 2022

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