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ISRCTN
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ISRCTN52746887
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ClinicalTrials.gov identifier
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Public title
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Evaluation of effect of sedation on diagnostic cervical 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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Protocol #5
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Study hypothesis
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To demonstrate sedation has no effect on the validity of diagnostic cervical facet joint nerve blocks.
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Lay summary
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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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Chronic neck pain
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Participants - inclusion criteria
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1. Subjects were between 18 and 90 years of age
2. Subjects had a history of chronic, function limiting, neck pain of at least 6 months duration
3. Subjects were able to give voluntary, written informed consent to participate in the investigation
4. Subjects who, in the opinion of the investigator, are able to understand the investigation, and/or cooperate with the investigational procedures
5. Subjects who had undergone diagnostic facet joint blocks and the diagnosis of cervical facet joint pain has been confirmed previously
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Participants - exclusion criteria
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1. Subjects without cervical facet joint pain
2. Subjects with uncontrollable major depression or uncontrolled psychiatric disorders
3. Pregnant or lactating women
4. Subjects with multiple complaints involving multiple other problems with overlapping pain complaints
5. Subjects unable to achieve appropriate positioning and inability to understand informed consent and protocol
6. Subjects with a history of adverse reaction to either midazolam or fentanyl
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Anticipated start date
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02/02/2004
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Anticipated end date
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30/04/2004
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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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180 patients, randomized into 3 groups with equal distribution.
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Interventions
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Intravenous injection of sodium chloride solution, midazolam, or fentanyl prior to cervical facet joint nerve blocks under fluoroscopy.
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Primary outcome measure(s)
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The administration of sedation with midazolam or fentanyl could be a confounding factor in the diagnosis of cervical facet joint pain in patients with chronic neck pain. However, if ≥80% pain relief with the ability to perform prior painful movements is used as the diagnostic standard, the effect of sedation on validity may be extremely low. In contrast, a significant number of patients may present as false-positives if ≥50% pain relief with ability to perform prior painful movements is used as the diagnostic criteria.
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Secondary outcome measure(s)
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Prudent administration of midazolam only to patients who are not relaxed may not have significant adverse effect on the diagnostic validity of controlled comparative local anesthetic blocks. On the other hand, fentanyl could confound the diagnosis with false-positive results in a significant proportion of patients.
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Sources of funding
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Ambulatory Surgery Center and Pain Management Center of Paducah (USA)
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Trial website
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Publications
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2004 results in http://www.ncbi.nlm.nih.gov/pubmed/16858481
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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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Ambulatory Surgery Center and Pain Management Center of Paducah (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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+1 270 554 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 website:
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http://www.thepainmd.com
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Date applied
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27/09/2005
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Last edited
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02/10/2008
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Date ISRCTN assigned
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17/11/2005
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