Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction

Interstitial Cystitis Clinical Trial

Official title:

Osteopathic Manipulation as a Therapeutic Intervention for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01311479
• Other study ID #: OMT-09
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2011
• Last updated: April 11, 2014
• Start date: November 2009
• Est. completion date: October 2018

Study information

• Verified date: April 2014
• Source: Pelvic and Sexual Health Institute
• Contact: Elizabeth Elias
• Phone: 267-479-2387
• Email: elias.pashi[@]yahoo.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The proposed study will evaluate the effectiveness of Osteopathic manipulation of the sacro-iliac joint (SIJ) and the lumbar spine in symptomatic female interstitial cystitis (IC) patients with sacro-iliac joint dysfunction.

It is predicted that Osteopathic manipulation for a period of 12 weeks will result in subjective indices of increased comfort and objective indices of lower O'Leary-Sant Questionnaire, Pelvic Floor Impact Questionnaire (PIFQ-7), Female Sexual Function Index (FSFI) and SF-12 scores, lower visual analog scores for pain and urgency, decreased frequency on voiding diary and greater variation in resting/contraction perineometry scores.

Description:

Patients will be evaluated and examined by an Osteopathic physician. This examination will consist of full osteopathic structural exam, and a focused examination of the sacroiliac joint and the surrounding musculature.

Subjects will then be treated based on the objective findings of the examination. Since the structural exam includes the whole body, other structural abnormalities will likely be identified and possible require treatment to aid in treatment of SIJD. Subjects will also be taught stretching routines in order to aid in treatment of the dysfunction.

Our control group will receive the same structural exam, and focused examination. Their treatment will involve massage, in an area not associated with the musculature of the SIJ. This will serve to identify a possible placebo effect, associated with simply providing a healing touch without focused treatment.

All of the subjects will be evaluated with standardized IC questionnaires at time of initial visit and subsequently re-evaluated with the same questionnaire in 4 week intervals. The patients will be followed for up to 6 months after treatment and evaluated at this time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female

• At least 18 years of age

• Patients who have osteopathic dysfunction

• Patients with the Diagnosis of IC and Sacroiliac joint dysfunction

• Patients currently stable on or off of a treatment regimen for IC for the past one month

• Patients not currently undergoing physical therapy for pelvic floor dysfunction or SI joint dysfunction

• Patients who have not used narcotics, skeletal muscle relaxants, or bladder instillations for the past month

• Willingness to participate in the trial by signing an informed consent

Exclusion Criteria:

• Pregnancy

• Pelvic Masses

• Patients with an Interstim neuromodulator implant

• Patients requiring narcotics, bladder instillations, or skeletal muscle relaxants

• History of vaginal or abdominal pelvic surgery within the last 3 months

• Having a bladder over-distention within the last 1 month

• Malignancy

• Known spinal arthropathies

• Hip replacements or other surgical stabilization

• Herniated disks

• Spinal stenosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Joint Diseases
• Sacroiliac Joint Somatic Dysfunction

Intervention

Procedure:
• Osteopathic Manipulation Therapy
Subjects will then be treated based on the objective findings of the examination. Since the structural exam includes the whole body, other structural abnormalities will likely be identified and possible require treatment to aid in treatment of SIJ. Subjects will also be taught stretching routines in order to aid in treatment of the dysfunction. Our control group will receive the same structural exam, and focused examination. Their treatment will involve massage, in an area not associated with the musculature of the SIJ. This will serve to identify a possible placebo effect, associated with simply providing a healing touch without focused treatment.

Locations

Country	Name	City	State
United States	Pelvic and Sexual Health Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Pelvic and Sexual Health Institute	Interstitial Cystitis Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Scores of Validated questionnaires pertaining to Interstitial Cystitis problems and symptoms	It is predicted that Osteopathic manipulation for a period of 12 weeks will result in subjective indices of increased comfort and objective indices of lower O'Leary-Sant Questionnaire, Pelvic Floor Impact Questionnaire (PIFQ-7), Female Sexual Function Index (FSFI) and SF-12 scores, lower visual analog scores for pain and urgency, decreased frequency on voiding diary and greater variation in resting/contraction perineometry scores.	Biweekly for three months	No