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

• ClinicalTrials.gov Identifier: NCT00434343
• Recruitment Status: Completed
• First Posted: February 13, 2007
• Last Update Posted: December 12, 2022
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: University of Pennsylvania
• Information provided by (Responsible Party): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information

• First Submitted Date: February 12, 2007
• First Posted Date: February 13, 2007
• Last Update Posted Date: December 12, 2022
• Study Start Date: November 2006
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Interstitial Cystitis
• Painful Bladder Syndrome
• Chronic Prostatitis
• Chronic Pelvic Pain Syndrome

Intervention

• 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

• 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 *

• 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. doi: 10.1016/j.juro.2009.04.022. Epub 2009 Jun 17.
• Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
• 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. 2013 Jan;189(1 Suppl):S75-85. doi: 10.1016/j.juro.2012.11.018.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 8, 2022): 47
• Original Enrollment (submitted: February 12, 2007): 48
• Actual Study Completion Date: November 2007
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00434343
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Original Responsible Party: Not Provided
• Current Study Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Original Study Sponsor: Same as current
• Collaborators: University of Pennsylvania

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

• PRS Account: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Verification Date: December 2022