Physical Therapy Trial for Pelvic Pain

Not Applicable

Completed

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

• Registration Number: NCT00434343
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-02-12
• Study First Submitted QC: 2007-02-12
• Study First Posted: 2007-02-13
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Global Therapeutic Massage (GTM)	Global Therapeutic Massage (GTM)	Weekly massages consisting of full body Western massage for 1hour.
Myofascial physical therapy (MPT)	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

Primary Outcome Measures

Name	Time	Method
Number consenting to join study out of eligible patients approached	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	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

Name	Time	Method
Global response assessment (GRA) Global response assessment	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	12 weeks	Treatment session completion was tracked and used to measure tolerability of treatment.
Number of adverse events reported by the participants	12 weeks	Number of adverse events reported by the participants

Trial Locations

Locations (5)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States