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)

Study Description

Brief Summary:

The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.

Condition or disease	Intervention/treatment	Phase
Interstitial Cystitis; Painful Bladder Syndrome; Chronic Prostatitis; Chronic Pelvic Pain Syndrome	Other: Global Therapeutic Massage (GTM); Other: Myofascial physical therapy (MPT)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
• Study Start Date: November 2006
• Actual Primary Completion Date: November 2007
• Actual Study Completion Date: November 2007

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Global Therapeutic Massage (GTM); Weekly massages consisting of full body Western massage for 1hour.	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	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

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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

Secondary Outcome Measures :

1. Number of adverse events reported by the participants [ Time Frame: 12 weeks ]
   Number of adverse events reported by the participants
2. 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
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Stanford University Medical Center

Stanford, California, United States, 94305

United States, Illinois

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611

Loyola University Medical Center

Maywood, Illinois, United States, 60153

United States, Michigan

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• ClinicalTrials.gov Identifier: NCT00434343
• Other Study ID Numbers: UPPCRN RCT1 - PT; U01DK065209 ( U.S. NIH Grant/Contract )
• First Posted: February 13, 2007
• Last Update Posted: December 12, 2022
• Last Verified: December 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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

Additional relevant MeSH terms:

Cystitis; Cystitis, Interstitial; Prostatitis; Syndrome; Pelvic Pain; Disease; Pathologic Processes; Pain; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Prostatic Diseases