Recruiting

Osteopathic Manipulation

Sponsor:

Pelvic and Sexual Health Institute

Code:

NCT01311479

Conditions

Interstitial Cystitis

Sacroiliac Joint Somatic Dysfunction

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Osteopathic Manipulation Therapy

Study Details

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.

Conditions

Interstitial Cystitis

Sacroiliac Joint Somatic Dysfunction

Study ID

NCT01311479

Start date

Nov, 2009

Status verified date

Apr, 2014

Completion date

Oct, 2018

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Elizabeth Elias

267-479-2387elias.pashi@yahoo.com

Locations

Pelvic and Sexual Health Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

elizabeth Elias

267-479-2387elias.pashi@yahoo.com

More Information

Sponsor

Pelvic and Sexual Health Institute

Last update posted

Apr 14, 2014

Last verified

Apr, 2014

Keywords

  • Osteopathic Manipulation
  • Interstitial Cystitis
  • Sacroiliac Joint Dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pelvic and Sexual Health Institute on 2014-04-14.