Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction

Not Applicable

• Conditions: Interstitial Cystitis; Sacroiliac Joint Somatic Dysfunction
• Interventions: Procedure: Osteopathic Manipulation Therapy

• Registration Number: NCT01311479
• Lead Sponsor: Pelvic and Sexual Health Institute

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-09
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-11
• Last Update Posted: 2014-04-14
• Primary Completion: 2017-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteopathic Manipulation	Osteopathic Manipulation Therapy	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 SIJ. Subjects will also be taught stretching routines in order to aid in treatment of the dysfunction.
Massage Therapy	Osteopathic Manipulation Therapy	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.

Primary Outcome Measures

Name	Time	Method
Improvement in Scores of Validated questionnaires pertaining to Interstitial Cystitis problems and symptoms	Biweekly for three months	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.

Trial Locations

Locations (1)

Pelvic and Sexual Health Institute; 🇺🇸 Philadelphia, Pennsylvania, United States