Physical Therapy Trial for Pelvic Pain

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)47 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Interstitial Cystitis Painful Bladder Syndrome Chronic Prostatitis Chronic Pelvic Pain Syndrome

Interventions

Global Therapeutic Massage (GTM)OTHER

Myofascial physical therapy (MPT)OTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: 12 weeks

Secondary Outcomes

Number of adverse events reported by the participants

Time frame: 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

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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