Osteopathic Manipulation Therapy in the Treatment of Interstitial Cystitis

NCT ID: NCT00873171

Last Updated: 2010-04-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-11-30

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.

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.

Conditions

Interstitial Cystitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

CAMC Health System

OTHER

Sponsor Role: lead

Responsible Party

CAMC Medical Staff - with admitting privileges

Principal Investigators

James P Tierney, D.O.

Role: PRINCIPAL_INVESTIGATOR

CAMC Medical Staff - with admitting privileges

Locations

James P. Tierney D.O.

Charleston, West Virginia, United States

Countries

United States

Other Identifiers

08-04-2046

Identifier Type: -

Identifier Source: org_study_id