Back to resultsA Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac (SI) Joint Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
radiofrequency denervation
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring sacroiliac joint, low back pain, radiofrequency
Eligibility Criteria
Inclusion Criteria:
- Sacroiliac joint pain
- Age > 18
Exclusion Criteria:
- No focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition
Sites / Locations
- Walter Reed Army Medical Center
- Johns Hopkins School of Medicine
Outcomes
Primary Outcome Measures
visual analogue scale pain score, Oswestry Disability Index
Secondary Outcome Measures
Medication reduction, global perceived effect, work status
Full Information
NCT ID
NCT00373724
First Posted
September 7, 2006
Last Updated
May 7, 2008
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT00373724
Brief Title
A Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac (SI) Joint Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
sacroiliac joint, low back pain, radiofrequency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
radiofrequency denervation
Primary Outcome Measure Information:
Title
visual analogue scale pain score, Oswestry Disability Index
Time Frame
1, 3 and 6 months postprocedure
Secondary Outcome Measure Information:
Title
Medication reduction, global perceived effect, work status
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sacroiliac joint pain
Age > 18
Exclusion Criteria:
No focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven P Cohen, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Srinivasa N Raja, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12677621
Citation
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.
Results Reference
background
PubMed Identifier
14560094
Citation
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.
Results Reference
background
PubMed Identifier
16244008
Citation
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.
Results Reference
background
PubMed Identifier
18648237
Citation
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.
Results Reference
derived
Learn more about this trial
A Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac (SI) Joint Pain
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