Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction

Pelvic and Sexual Health Institute

Status

Unknown

Conditions

Interstitial Cystitis

Sacroiliac Joint Somatic Dysfunction

Treatments

Procedure: Osteopathic Manipulation Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01311479

OMT-09

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Osteopathic Manipulation

Active Comparator group

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.

Treatment:

Procedure: Osteopathic Manipulation Therapy

Massage Therapy

Active Comparator group

Description:

Treatment:

Procedure: Osteopathic Manipulation Therapy