Interstitial Cystitis Clinical Trial
Official title:
Osteopathic Manipulation as a Therapeutic Intervention for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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