Contact information
Type
Scientific
Primary contact
Dr Laxmaiah Manchikanti
ORCID ID
Contact details
2831 Lone Oak Road
Paducah
KY
42003
United States of America
+1 270 554 8373
drm@asipp.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol #5
Study information
Scientific title
Acronym
Study hypothesis
To demonstrate sedation has no effect on the validity of diagnostic cervical facet joint nerve blocks.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic neck pain
Intervention
Intravenous injection of sodium chloride solution, midazolam, or fentanyl prior to cervical facet joint nerve blocks under fluoroscopy.
Intervention type
Drug
Phase
Not Specified
Drug names
Sodium chloride solution, midazolam and fentanyl
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
02/02/2004
Overall trial end date
30/04/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
180 patients, randomized into 3 groups with equal distribution.
Participant exclusion criteria
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
Recruitment start date
02/02/2004
Recruitment end date
30/04/2004
Locations
Countries of recruitment
United States of America
Trial participating centre
2831 Lone Oak Road
Paducah, KY
42003
United States of America
Sponsor information
Organisation
Ambulatory Surgery Center and Pain Management Center of Paducah (USA)
Sponsor details
2831 Lone Oak Road
Paducah
KY
42003
United States of America
+1 270 554 8373
drm@asipp.org
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Ambulatory Surgery Center and Pain Management Center of Paducah (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/16858481
Publication citations
-
Results
Manchikanti L, Damron KS, Rivera JJ, McManus CD, Jackson SD, Barnhill RC, Martin JC, Evaluation of the effect of sedation as a confounding factor in the diagnostic validity of lumbar facet joint pain: a prospective, randomized, double-blind, placebo-controlled evaluation., Pain Physician, 2004, 7, 4, 411-417.