|
ISRCTN
|
ISRCTN23482653
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Evaluation of effect of sedation on diagnostic lumbar facet joint nerve blocks
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
Protocol #6
|
|
Study hypothesis
|
To demonstrate that sedation has no effect on the validity of diagnostic lumbar facet joint nerve blocks.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United States of America
|
|
Disease/condition/study domain
|
Chronic low back pain
|
|
Participants - inclusion criteria
|
1. Subjects were between 18 and 90 years of age
2. Subjects with a history of chronic, function limiting, low back pain of at least 6 months duration
3. Subjects 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. Patients who have undergone diagnostic facet joint blocks and the diagnosis of lumbar facet joint pain has been previously confirmed
|
|
Participants - exclusion criteria
|
1. Patients without lumbar facet joint pain
2. Patients with uncontrolled major depression or uncontrolled psychiatric disorders
3. Pregnant or lactating women
4. Patients with multiple complaints involving multiple other problems which have overlapping pain complaints
5. Patients unable to achieve proper positioning or unable to understand informed consent and protocol
6. Patients with a history of adverse reaction to either midazolam or fentanyl
|
|
Anticipated start date
|
02/02/2004
|
|
Anticipated end date
|
30/06/2004
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
180 subjects, randomized into 3 groups with equal distribution
|
|
Interventions
|
Intravenous injection of sodium chloride solution, midazolam, or fentanyl prior to lumbar facet joint nerve blocks under fluoroscopy.
|
|
Primary outcome measure(s)
|
For a small proportion of patients with chronic low back pain, the administration of sedation with midazolam or fentanyl can be a confounding factor in the diagnosis of lumbar facet joint pain. The study shows that an intravenous preoperative sedative dose of a narcotic such as fentanyl or an anxiolytic such as midazolam is no more likely to cause a small proportion of patients to report false positive pain relief with active motion testing than sodium chloride placebo.
|
|
Secondary outcome measure(s)
|
The study suggests that prudent administration of midazolam or fentanyl to patients who are not relaxed may not have any significant adverse effect on the diagnostic validity of controlled comparative local anesthetic blocks.
|
|
Sources of funding
|
Ambulatory Surgery Center and Pain Management Center of Paducah (USA)
|
|
Trial website
|
|
|
Publications
|
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/16858466
|
|
Contact name
|
Dr
Laxmaiah
Manchikanti
|
|
Address
|
2831 Lone Oak Road
|
|
City/town
|
Paducah, KY
|
|
Zip/Postcode
|
42003
|
|
Country
|
United States of America
|
|
Tel
|
+1 270 554 8373
|
|
Fax
|
+1 270 554 8987
|
|
Email
|
drm@asipp.org
|
|
Sponsor
|
Ambulatory Surgery Center and Pain Management Center of Paducah (USA)
|
|
Address
|
2831 Lone Oak Road
|
|
City/town
|
Paducah, KY
|
|
Zip/Postcode
|
42003
|
|
Country
|
United States of America
|
|
Tel
|
+1 270 554 8373
|
|
Fax
|
+1 270 554 8987
|
|
Email
|
drm@asipp.org
|
|
Sponsor website:
|
http://www.thepainmd.com
|
|
Date applied
|
27/09/2005
|
|
Last edited
|
13/10/2008
|
|
Date ISRCTN assigned
|
17/11/2005
|
