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

A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes

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

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis; Painful Bladder Syndrome; Chronic Prostatitis; Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Other: Global Therapeutic Massage (GTM); Other: Myofascial physical therapy (MPT)

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
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events reported by the participants	Number of adverse events reported by the participants	12 weeks
Global response assessment (GRA) Global response assessment	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	12 weeks
Tolerability of treatment measured by number of treatment sessions participants completed	Treatment session completion was tracked and used to measure tolerability of treatment.	12 weeks

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• 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

Publications and helpful links

General Publications

• 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. 2009 Aug;182(2):570-80. doi: 10.1016/j.juro.2009.04.022. Epub 2009 Jun 17.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: February 12, 2007
• First Submitted That Met QC Criteria: February 12, 2007
• First Posted (Estimate): February 13, 2007

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Interstitial Cystitis; Chronic Prostatitis; Painful Bladder Syndrome; Chronic Pelvic Pain Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Pain; Neurologic Manifestations; Disease; Prostatic Diseases; Syndrome; Cystitis; Cystitis, Interstitial; Pelvic Pain; Prostatitis
• Other Study ID Numbers: UPPCRN RCT1 - PT; U01DK065209 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No