Osteopathic Manipulation Therapy in the Treatment of Interstitial Cystitis

This study has been completed.
Sponsor:
Information provided by:
CAMC Health System
ClinicalTrials.gov Identifier:
NCT00873171
First received: March 31, 2009
Last updated: April 15, 2010
Last verified: April 2010
  Purpose

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
Interstitial Cystitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Osteopathic Manipulation Therapy in the Treatment of Interstitial Cystitis

Resource links provided by NLM:


Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • Effectiveness of Osteopathic Manipulation therapy over standard of care invasive procedures for the treatment of interstitial cystitis. [ Time Frame: Within 2 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Within 2 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

A sample of 60 patients that have a confirmed diagnosis of Interstitial Cystitis as patients of Urological Surgical Associates and Charleston Area Medical Center (CAMC) based on current diagnostic recommendations. The patients will be selected based on their clinical history of interstitial cystitis.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873171

Locations
United States, West Virginia
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
  More Information

No publications provided

Responsible Party: James P. Tierney DO., CAMC Medical Staff - with admitting privileges
ClinicalTrials.gov Identifier: NCT00873171     History of Changes
Other Study ID Numbers: 08-04-2046
Study First Received: March 31, 2009
Last Updated: April 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by CAMC Health System:
Osteopathic Manipulation

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014