A randomized, prospective, double-blind, placebo-controlled evaluation of the effect of sedation on combined diagnostic cervical and lumbar facet joint nerve blocks
- Conditions
- Musculoskeletal DiseasesBack pain
- Registration Number
- ISRCTN76376497
- Lead Sponsor
- Institutional Review Board of Ambulatory Surgery Center (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1. Subjects between 18 and 90 years of age
2. Subjects with a history of chronic, function limiting, low back and neck pain of at least 6 months in duration
3. Subjects who are able to give voluntary, written informed consent to participate in this investigation
4. Subjects who, in the opinion of the investigator, are able to understand this investigation, and/or co-operate with the investigational procedures
5. Subjects should have undergone diagnostic facet joint blocks and the combined diagnostic cervical and lumbar facet joint pain has been confirmed previously
1. Absence of combined cervical and lumbar facet joint pain
2. Uncontrolled major depression or uncontrolled psychiatric disorders
3. Women who are pregnant or lactating
4. Patients with multiple complaints involving multiple other problems which have overlapping pain complaints
5. Inability to achieve appropriate positioning and inability to understand informed consent and protocol
6. History of adverse reaction to either midazolam or fentanyl
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Comparison of midazolam and fentanyl with placebo (sodium chloride injection)<br>2. To demonstrate a lack of clinically significant difference in the treatment groups after 10 minutes post-treatment in the:<br>2.1 Numeric pain scale in neck and low back<br>2.2 Ability to perform the painful movements in neck and low back, which were painful prior to intravenous administration of sedation
- Secondary Outcome Measures
Name Time Method ot provided at time of registration