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ISRCTN
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ISRCTN76376497
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ClinicalTrials.gov identifier
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Public title
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A randomized, prospective, double-blind, placebo-controlled evaluation of the effect of sedation on combined diagnostic cervical and lumbar facet joint nerve blocks
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Scientific title
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Acronym
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N/A
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Serial number at source
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7
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Study hypothesis
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To demonstrate the lack of effect of sedation on the validity of diagnostic cervical and lumbar facet joint nerve blocks.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Back pain
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/05/2004
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Anticipated end date
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31/10/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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A total of 60 patients, randomized into 3 groups with equal size
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Interventions
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Patients with combined chronic neck and low back pain of facet joint origin identified with controlled, comparative local anesthetic nerve blocks will receive intravenous injection of sodium chloride solution, midazolam, or fentanyl prior to lumbar facet joint nerve blocks under fluoroscopy.
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Primary outcome measure(s)
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1. Comparison of midazolam and fentanyl with placebo (sodium chloride injection)
2. To demonstrate a lack of clinically significant difference in the treatment groups after 10 minutes post-treatment in the:
2.1 Numeric pain scale in neck and low back
2.2 Ability to perform the painful movements in neck and low back, which were painful prior to intravenous administration of sedation
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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No other external support or funding were received in completion of this study.
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16700280
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Contact name
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Dr
Laxmaiah
Manchikanti
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Address
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2831 Lone Oak Road
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City/town
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Paducah, KY
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Zip/Postcode
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42003
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Country
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United States of America
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Tel
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+1 270 554 8373
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Fax
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+1 270 554 8987
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Email
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drm@asipp.org
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Sponsor
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Institutional Review Board of Ambulatory Surgery Center (USA)
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Address
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2831 Lone Oak Road
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City/town
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Paducah, KY
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Zip/Postcode
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42003
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Country
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United States of America
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Tel
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+1 270 775 8373
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Fax
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+1 270 554 8987
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Email
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painmgmt@apex.net
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Date applied
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21/06/2005
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Last edited
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16/08/2011
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Date ISRCTN assigned
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22/06/2005
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