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Completed

NCT Number: NCT00434343

Physical Therapy Trial for Pelvic Pain

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

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Key information

Conditions

Interstitial Cystitis Chronic Pelvic Pain Syndrome Chronic Prostatitis Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Painful Bladder Syndrome Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Medical Center, Stanford, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Number consenting to join study out of eligible patients approached

    Time frame: 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).

  2. Number of times therapists adhered to prescribed therapeutic protocol

    Time frame: 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 outcomes

  1. Number of adverse events reported by the participants

    Time frame: 12 weeks

    Number of adverse events reported by the participants

  2. Global response assessment (GRA) Global response assessment

    Time frame: 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

  3. Tolerability of treatment measured by number of treatment sessions participants completed

    Time frame: 12 weeks

    Treatment session completion was tracked and used to measure tolerability of treatment.

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

  • University of Pennsylvania

Registry information

Official study title

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

Acronym: UPPCRN-RCT#1

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 13, 2007
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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