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Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction

Primary Purpose

Interstitial Cystitis, Sacroiliac Joint Somatic Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulation Therapy
Sponsored by
Pelvic and Sexual Health Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Osteopathic Manipulation, Interstitial Cystitis, Sacroiliac Joint Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pelvic and Sexual Health InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Osteopathic Manipulation

Massage Therapy

Arm 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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2011
Last Updated
April 11, 2014
Sponsor
Pelvic and Sexual Health Institute
Collaborators
Interstitial Cystitis Association
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1. Study Identification

Unique Protocol Identification Number
NCT01311479
Brief Title
Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction
Official Title
Osteopathic Manipulation as a Therapeutic Intervention for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pelvic and Sexual Health Institute
Collaborators
Interstitial Cystitis Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Sacroiliac Joint Somatic Dysfunction
Keywords
Osteopathic Manipulation, Interstitial Cystitis, Sacroiliac Joint Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic Manipulation
Arm Type
Active Comparator
Arm 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 SIJ. Subjects will also be taught stretching routines in order to aid in treatment of the dysfunction.
Arm Title
Massage Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulation Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in Scores of Validated questionnaires pertaining to Interstitial Cystitis problems and symptoms
Description
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.
Time Frame
Biweekly for three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Elias
Phone
267-479-2387
Email
elias.pashi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristene E Whitmore, M.D.
Organizational Affiliation
Pelvic and Sexual Health Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pelvic and Sexual Health Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
elizabeth Elias
Phone
267-479-2387
Email
elias.pashi@yahoo.com
First Name & Middle Initial & Last Name & Degree
Brian Sperling, D.O.
First Name & Middle Initial & Last Name & Degree
Allison Bloom, D.O.
First Name & Middle Initial & Last Name & Degree
Susan Kellogg-Spadt, Ph.D, CRNP
First Name & Middle Initial & Last Name & Degree
Amy Rejba, MSN, CRNP
First Name & Middle Initial & Last Name & Degree
Jennifer Fariello, MSN, CRNP

12. IPD Sharing Statement

Learn more about this trial

Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction

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