Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction (NCT01311479) | Clinical Trial Compass
UnknownNot Applicable
Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction
United States40 participantsStarted 2009-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement in Scores of Validated questionnaires pertaining to Interstitial Cystitis problems and symptoms