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Osteopathic Manipulation Therapy in the Treatment of Interstitial Cystitis

Sponsor
CAMC Health System (Other)
Overall Status
Completed
CT.gov ID
NCT00873171
Collaborator
(none)
24
Enrollment
1
Location
10
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

As a safe and noninvasive method of treatment, the intent of the study is to show that Osteopathic manipulation therapy is a beneficial treatment for the aggravating bladder symptoms seen in all patients with interstitial cystitis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The management of interstitial cystitis is predominantly based on the reduction of the symptoms of frequency, urgency, and pain.In addition to Osteopathic manipulation Other conservative treatments frequently include dietary modification, pharmaceuticals, bladder training, neuromodulation, and stress reduction. The goal of Osteopathic manipulation is to relax the pelvic muscles used by the bladder and improve the flow of blood and lymph fluid to this region, which may result in easing pain and discomfort associated with cystitis.Some physicians have found that Osteopathic Manipulation works for some people as an alternative to surgery. A secondary objective will be to determine if the increased attention and power of touch are as effective as OMT in treating patients with interstitial cystitis based on the results of using attention control treatment in some patients.Thus, this is a pilot study comparing OMT to an attention control arm and standard of care arm of treatment.We will review palpatory visceromatic reflex changes as documented by tissue texture changes, asymmetry, restriction of motion and tenderness pre and post treatment.Physical examination including detailed musculoskeletal examination of the lumbosacral region will be performed pre and post and then compared the results.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    24 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Osteopathic Manipulation Therapy in the Treatment of Interstitial Cystitis
    Study Start Date :
    Jan 1, 2009
    Actual Primary Completion Date :
    Nov 1, 2009
    Actual Study Completion Date :
    Nov 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    1. OMT

    This procedure consist of Sacral rocking is performed by placing the heel of the practitioner's hand over the sacrum and by using the palpatory skills of an osteopathic physician; rock the sacrum into a position with no restriction. Myofascial release will utilize various physical motions to place the patients lumbosacral region in a position of maximal comfort and tissue release.
    2. Attention control OMT

    The procedure consist of light pressure applied to certain painful areas of the body and back to decrease pain and help patient relax. The physician will look for areas of the body that hurt, lay his/her hands on the those places, and apply light pressure.
    3. Standard of Care

    This procedure consists of various conservative treatments that can help reduce stress. Those include dietary modifications, pharmaceuticals, bladder training, and neuromodulation. If these treatments are not successful, minimally invasive surgical procedures is performed.

    Outcome Measures

    Primary Outcome Measures

    1. Effectiveness of Osteopathic Manipulation therapy over standard of care invasive procedures for the treatment of interstitial cystitis. [Within 2 weeks of treatment]

    Secondary Outcome Measures

    1. To determine if the increased attention and power of touch are as effective as OMT in treating patients with IC based on the results of using attention control treatment in some patients. [Within 2 weeks of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • The criteria for treatment is that the patient must exhibit symptoms of IC for at least one year and have a known diagnosis based on history and clinical findings including glomerulations of the bladder wall seen on cystoscopic examination.
    Exclusion Criteria:
    • Patients who are not eligible are those who have contraindications to OMT such as hypersensitivity to palpation, indurations or mass/tumor, adenopathy, cancer, or local infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 James P. Tierney D.O. Charleston West Virginia United States 25304

    Sponsors and Collaborators

    • CAMC Health System

    Investigators

    • Principal Investigator: James P Tierney, D.O., CAMC Medical Staff - with admitting privileges

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00873171
    Other Study ID Numbers:
    • 08-04-2046
    First Posted:
    Apr 1, 2009
    Last Update Posted:
    Apr 16, 2010
    Last Verified:
    Apr 1, 2010
    Keywords provided by , ,
    Osteopathic Manipulation
    Additional relevant MeSH terms:
    Cystitis
    Cystitis, Interstitial

    Study Results

    No Results Posted as of Apr 16, 2010