A randomized, prospective, double-blind, placebo-controlled evaluation of the effect of sedation on combined diagnostic cervical and lumbar facet joint nerve blocks

ISRCTN	ISRCTN76376497
DOI	https://doi.org/10.1186/ISRCTN76376497
Secondary identifying numbers	7

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Laxmaiah Manchikanti
Scientific

2831 Lone Oak Road
Paducah, KY
42003
United States of America

Phone	+1 270 554 8373
Email	drm@asipp.org

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title
Study objectives	To demonstrate the lack of effect of sedation on the validity of diagnostic cervical and lumbar facet joint nerve blocks.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Back pain
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Sodium chloride solution, midazolam and fentanyl
Primary outcome measure	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
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2004
Completion date	31/10/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	A total of 60 patients, randomized into 3 groups with equal size
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/05/2004
Date of final enrolment	31/10/2005

2831 Lone Oak Road

Paducah, KY
42003
United States of America

Institutional Review Board of Ambulatory Surgery Center (USA)
Hospital/treatment centre

2831 Lone Oak Road
Paducah, KY
42003
United States of America

Not defined

No other external support or funding were received in completion of this study.

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2006		Yes	No