Working… Menu

A Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac (SI) Joint Pain

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. Read our disclaimer for details. Identifier: NCT00373724
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : May 9, 2008
Information provided by:
Johns Hopkins University

Brief Summary:
In order to determine whether L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation is effective for sacroiliac (SI) joint pain, we are conducting a randomized, controlled study.

Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: radiofrequency denervation Not Applicable

Detailed Description:
30 subjects with SI joint pain confirmed by SI joint injections will be randomized to receive either L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation or sham denervation. To facilitate patient blinding, in both groups 1 ml of lidocaine will be injected before true (or sham) denervation so patients cannot feel heating. The stimulation will be the same for both groups and blinding assessed after the procedure. Follow-up visits will be at 1,3 and 6-months postprocedure.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : November 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Primary Outcome Measures :
  1. visual analogue scale pain score, Oswestry Disability Index [ Time Frame: 1, 3 and 6 months postprocedure ]

Secondary Outcome Measures :
  1. Medication reduction, global perceived effect, work status

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sacroiliac joint pain
  • Age > 18

Exclusion Criteria:

  • No focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition

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 identifier (NCT number): NCT00373724

Layout table for location information
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Layout table for investigator information
Principal Investigator: Steven P Cohen, MD Johns Hopkins School of Medicine
Study Director: Srinivasa N Raja, MD Johns Hopkins School of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00373724    
Other Study ID Numbers: 05-03-23-05
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008
Keywords provided by Johns Hopkins University:
sacroiliac joint
low back pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Neurologic Manifestations