Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Interstitial Cystitis, Sacroiliac Joint Somatic Dysfunction

Intervention / Treatment
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* Procedure: Osteopathic Manipulation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Osteopathic Manipulation<br>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. | Procedure: Osteopathic Manipulation Therapy<br>* 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.<br>|
| Active Comparator: Massage Therapy<br>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. | Procedure: Osteopathic Manipulation Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic Manipulation, Interstitial Cystitis, Sacroiliac Joint Dysfunction