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

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ClinicalTrials.gov Identifier: NCT00373724
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : May 9, 2008
Sponsor:
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.

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


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

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 ClinicalTrials.gov identifier (NCT number): NCT00373724


Locations
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
Investigators
Principal Investigator: Steven P Cohen, MD Johns Hopkins School of Medicine
Study Director: Srinivasa N Raja, MD Johns Hopkins School of Medicine