Clinical trial NCT00873171: Osteopathic Manipulation Therapy in the Treatment of Interstitial Cystitis
Official title: Osteopathic Manipulation Therapy in the Treatment of Interstitial Cystitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Cystitis
Keywords: Osteopathic Manipulation
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2009-04-01
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Effectiveness of Osteopathic Manipulation therapy over standard of care invasive procedures for the treatment of interstitial cystitis.
timeFrame: Within 2 weeks of treatment
Secondary outcomes:
measure: 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.
timeFrame: Within 2 weeks of treatment
Other outcomes:
Locations:
city: Charleston
country: United States
facility: James P. Tierney D.O.
state: West Virginia
Study officials:
affiliation: CAMC Medical Staff - with admitting privileges
name: James P Tierney, D.O.
role: PRINCIPAL_INVESTIGATOR
References: