Status:
COMPLETED
Effect of Sedation on Diagnostic Injections
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Walter Reed National Military Medical Center
Conditions:
Sacroiliac Joint Pain
Sympathetically Maintained Pain
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Interventional pain procedures have diagnostic, prognostic and therapeutic value. It is well-documented that the reference standard for identifying a pain generator is a low-volume block performed wit...
Detailed Description
Sixty-eight patients with sacroiliac (SI) joint or sympathetically-maintained pain will be randomized in a crossover fashion to receive diagnostic nerve blocks either with or without intravenous sedat...
Eligibility Criteria
Inclusion
- Chronic pain \> 4 weeks but \< 10 years in duration
- Suspected SI joint or sympathetically-maintained pain based on history and physical exam
- May benefit from a sacroiliac joint or sympathetic block
- Pain on 0-10 NRS scale \> 3/10 in intensity
Exclusion
- No previous interventional pain-alleviating injections for the same condition within the past 3 years
- Uncontrolled coagulopathy
- Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age
- Allergy to contrast dye or amide local anesthetics
- Unstable medical or psychiatric condition (e.g. unstable angina, congestive heart failure or severe depression) that could preclude an optimal treatment response
- Systemic infection
- Age \< 18 or \> 75 years
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01472835
Start Date
March 1 2011
End Date
February 1 2013
Last Update
December 15 2016
Active Locations (1)
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1
Johns Hopkins Blaustein Pain Treatment Center
Baltimore, Maryland, United States, 21205