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Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction

This study is currently recruiting participants.
Verified April 2014 by Kristene Whitmore, M.D., Pelvic and Sexual Health Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01311479
First Posted: March 9, 2011
Last Update Posted: April 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Interstitial Cystitis Association
Information provided by (Responsible Party):
Kristene Whitmore, M.D., Pelvic and Sexual Health Institute
  Purpose

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.


Condition Intervention
Interstitial Cystitis Sacroiliac Joint Somatic Dysfunction Procedure: Osteopathic Manipulation Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Osteopathic Manipulation as a Therapeutic Intervention for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction

Resource links provided by NLM:


Further study details as provided by Kristene Whitmore, M.D., Pelvic and Sexual Health Institute:

Primary Outcome Measures:
  • Improvement in Scores of Validated questionnaires pertaining to Interstitial Cystitis problems and symptoms [ Time Frame: Biweekly for three months ]
    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.


Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Osteopathic Manipulation

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

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.

Active Comparator: Massage Therapy
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

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.


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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311479


Contacts
Contact: Elizabeth Elias 267-479-2387 elias.pashi@yahoo.com

Locations
United States, Pennsylvania
Pelvic and Sexual Health Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: elizabeth Elias    267-479-2387    elias.pashi@yahoo.com   
Sub-Investigator: Brian Sperling, D.O.         
Sub-Investigator: Allison Bloom, D.O.         
Sub-Investigator: Susan Kellogg-Spadt, Ph.D, CRNP         
Sub-Investigator: Amy Rejba, MSN, CRNP         
Sub-Investigator: Jennifer Fariello, MSN, CRNP         
Sponsors and Collaborators
Pelvic and Sexual Health Institute
Interstitial Cystitis Association
Investigators
Principal Investigator: Kristene E Whitmore, M.D. Pelvic and Sexual Health Institute
  More Information

Responsible Party: Kristene Whitmore, M.D., Medical Director, Pelvic and Sexual Health Institute
ClinicalTrials.gov Identifier: NCT01311479     History of Changes
Other Study ID Numbers: OMT-09
First Submitted: March 7, 2011
First Posted: March 9, 2011
Last Update Posted: April 14, 2014
Last Verified: April 2014

Keywords provided by Kristene Whitmore, M.D., Pelvic and Sexual Health Institute:
Osteopathic Manipulation
Interstitial Cystitis
Sacroiliac Joint Dysfunction

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Joint Diseases
Urinary Bladder Diseases
Urologic Diseases
Musculoskeletal Diseases