Clinical Trials Directory

Trials / Unknown

UnknownNCT01311479

Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Pelvic and Sexual Health Institute · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREOsteopathic Manipulation TherapySubjects 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.

Timeline

Start date
2009-11-01
Primary completion
2017-10-01
Completion
2018-10-01
First posted
2011-03-09
Last updated
2014-04-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01311479. Inclusion in this directory is not an endorsement.