Physical Therapy Trial for Pelvic Pain
UPPCRN-RCT#1
A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
2 other identifiers
interventional
47
1 country
5
Brief Summary
The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2006
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 12, 2007
CompletedFirst Posted
Study publicly available on registry
February 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedDecember 12, 2022
December 1, 2022
1 year
February 12, 2007
December 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number consenting to join study out of eligible patients approached
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).
6 months
Number of times therapists adhered to prescribed therapeutic protocol
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
12 weeks
Secondary Outcomes (3)
Number of adverse events reported by the participants
12 weeks
Global response assessment (GRA) Global response assessment
12 weeks
Tolerability of treatment measured by number of treatment sessions participants completed
12 weeks
Study Arms (2)
Global Therapeutic Massage (GTM)
PLACEBO COMPARATORWeekly massages consisting of full body Western massage for 1hour.
Myofascial physical therapy (MPT)
ACTIVE COMPARATORConnective 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- neurologic disorder affecting bladder
- bladder cancer, prostate cancer, or urethral cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Stanford University Medical Center
Stanford, California, 94305, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Related Publications (3)
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.
PMID: 19535099RESULTImamura 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.
PMID: 32734597DERIVEDFitzgerald 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.
PMID: 23234638DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2007
First Posted
February 13, 2007
Study Start
November 1, 2006
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
December 12, 2022
Record last verified: 2022-12