Osteopathic Manipulation Therapy in the Treatment of Interstitial Cystitis

NCT00873171 | Completed

• 1 other identifier: 08-04-2046
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Cystitis

Keywords

Osteopathic Manipulation

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Osteopathic Manipulation therapy over standard of care invasive procedures for the treatment of interstitial cystitis.

  Within 2 weeks of treatment

Secondary Outcomes (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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

James P. Tierney D.O.

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• James P Tierney, D.O.

  CAMC Medical Staff - with admitting privileges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 16, 2010

Record last verified: 2010-04

Locations

US (1)