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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedApril 14, 2014
April 1, 2014
7.9 years
March 7, 2011
April 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Osteopathic Manipulation
ACTIVE COMPARATORPatients 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
ACTIVE COMPARATOROur 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pelvic and Sexual Health Institute
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristene E Whitmore, M.D.
Pelvic and Sexual Health Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
March 7, 2011
First Posted
March 9, 2011
Study Start
November 1, 2009
Primary Completion
October 1, 2017
Study Completion
October 1, 2018
Last Updated
April 14, 2014
Record last verified: 2014-04