A Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac (SI) Joint Pain
May 7, 2008 updated by: Johns Hopkins University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
District of Columbia
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Washington, District of Columbia, United States, 20307
- Walter Reed Army Medical Center
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Sacroiliac joint pain
- Age > 18
Exclusion Criteria:
- No focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
visual analogue scale pain score, Oswestry Disability Index
Time Frame: 1, 3 and 6 months postprocedure
|
1, 3 and 6 months postprocedure
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Medication reduction, global perceived effect, work status
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven P Cohen, MD, Johns Hopkins School of Medicine
- Study Director: Srinivasa N Raja, MD, Johns Hopkins School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cohen SP, Abdi S. Lateral branch blocks as a treatment for sacroiliac joint pain: A pilot study. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):113-9. doi: 10.1053/rapm.2003.50029.
- Yin W, Willard F, Carreiro J, Dreyfuss P. Sensory stimulation-guided sacroiliac joint radiofrequency neurotomy: technique based on neuroanatomy of the dorsal sacral plexus. Spine (Phila Pa 1976). 2003 Oct 15;28(20):2419-25. doi: 10.1097/01.BRS.0000085360.03758.C3.
- Cohen SP. Sacroiliac joint pain: a comprehensive review of anatomy, diagnosis, and treatment. Anesth Analg. 2005 Nov;101(5):1440-1453. doi: 10.1213/01.ANE.0000180831.60169.EA.
- Cohen SP, Hurley RW, Buckenmaier CC 3rd, Kurihara C, Morlando B, Dragovich A. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. 2008 Aug;109(2):279-88. doi: 10.1097/ALN.0b013e31817f4c7c.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (ACTUAL)
August 1, 2007
Study Completion (ACTUAL)
August 1, 2007
Study Registration Dates
First Submitted
September 7, 2006
First Submitted That Met QC Criteria
September 7, 2006
First Posted (ESTIMATE)
September 8, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
May 9, 2008
Last Update Submitted That Met QC Criteria
May 7, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-03-23-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.