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

Primary Purpose

Interstitial Cystitis, Painful Bladder Syndrome, Chronic Prostatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Global Therapeutic Massage (GTM)
Myofascial physical therapy (MPT)
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial Cystitis, Painful Bladder Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Medical Center
  • Northwestern University Feinberg School of Medicine
  • Loyola University Medical Center
  • William Beaumont Hospital
  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Global Therapeutic Massage (GTM)

Myofascial physical therapy (MPT)

Arm Description

Weekly massages consisting of full body Western massage for 1hour.

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

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

Number of adverse events reported by the participants
Number of adverse events reported by the participants
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
Tolerability of treatment measured by number of treatment sessions participants completed
Treatment session completion was tracked and used to measure tolerability of treatment.

Full Information

First Posted
February 12, 2007
Last Updated
December 8, 2022
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00434343
Brief Title
Physical Therapy Trial for Pelvic Pain
Acronym
UPPCRN-RCT#1
Official Title
A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Painful Bladder Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome
Keywords
Interstitial Cystitis, Painful Bladder Syndrome, Chronic Prostatitis, Chronic Pelvic Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Global Therapeutic Massage (GTM)
Arm Type
Placebo Comparator
Arm Description
Weekly massages consisting of full body Western massage for 1hour.
Arm Title
Myofascial physical therapy (MPT)
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Global Therapeutic Massage (GTM)
Intervention Type
Other
Intervention Name(s)
Myofascial physical therapy (MPT)
Intervention Description
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
Primary Outcome Measure Information:
Title
Number consenting to join study out of eligible patients approached
Description
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).
Time Frame
6 months
Title
Number of times therapists adhered to prescribed therapeutic protocol
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of adverse events reported by the participants
Description
Number of adverse events reported by the participants
Time Frame
12 weeks
Title
Global response assessment (GRA) Global response assessment
Description
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
Time Frame
12 weeks
Title
Tolerability of treatment measured by number of treatment sessions participants completed
Description
Treatment session completion was tracked and used to measure tolerability of treatment.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kusek, PhD
Organizational Affiliation
National Institute of Diabetes & Digestive & Kidney Diseases/National Institutes of Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Leroy Nyberg, PhD, MD
Organizational Affiliation
National Institute of Diabetes & Digestive & Kidney Diseases/National Institutes of Health
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19535099
Citation
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.
Results Reference
result
PubMed Identifier
32734597
Citation
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.
Results Reference
derived
PubMed Identifier
23234638
Citation
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.
Results Reference
derived

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Physical Therapy Trial for Pelvic Pain

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