A Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac (SI) Joint Pain
1 other identifier
interventional
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable low-back-pain
Started Nov 2005
Typical duration for not_applicable low-back-pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2006
CompletedFirst Posted
Study publicly available on registry
September 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedMay 9, 2008
May 1, 2008
1.7 years
September 7, 2006
May 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
visual analogue scale pain score, Oswestry Disability Index
1, 3 and 6 months postprocedure
Secondary Outcomes (1)
Medication reduction, global perceived effect, work status
Interventions
Eligibility Criteria
You may qualify if:
- Sacroiliac joint pain
- Age \> 18
You may not qualify if:
- No focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205, United States
Related Publications (4)
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.
PMID: 12677621BACKGROUNDYin 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.
PMID: 14560094BACKGROUNDCohen 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.
PMID: 16244008BACKGROUNDCohen 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.
PMID: 18648237DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven P Cohen, MD
Johns Hopkins School of Medicine
- STUDY DIRECTOR
Srinivasa N Raja, MD
Johns Hopkins School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2006
First Posted
September 8, 2006
Study Start
November 1, 2005
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
May 9, 2008
Record last verified: 2008-05