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

March 31, 2009
April 15, 2010
January 2009
November 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00873171 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Osteopathic Manipulation Therapy in the Treatment of Interstitial Cystitis
Osteopathic Manipulation Therapy in the Treatment of Interstitial Cystitis

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

Interstitial Cystitis
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00873171
08-04-2046
No
James P. Tierney DO., CAMC Medical Staff - with admitting privileges
CAMC Health System
Not Provided
Principal Investigator: James P Tierney, D.O. CAMC Medical Staff - with admitting privileges
CAMC Health System
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP