Physical Therapy Trial for Pelvic Pain

Interstitial Cystitis Clinical Trial

— UPPCRN-RCT#1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434343
• Other study ID #: UPPCRN RCT1 - PT
• Secondary ID: U01DK065209
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Est. completion date: November 2007

Study information

• Verified date: December 2022
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pelvic Pain Syndrome
• Chronic Prostatitis
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Painful Bladder Syndrome
• Pelvic Pain
• Prostatitis
• Syndrome

Intervention

Other:
• Global Therapeutic Massage (GTM)

• 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

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Loyola University Medical Center	Maywood	Illinois
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, N — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of adverse events reported by the participants	Number of adverse events reported by the participants	12 weeks
Secondary	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
Secondary	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