Condition category
Musculoskeletal Diseases
Date applied
27/09/2005
Date assigned
17/11/2005
Last edited
13/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 #6

Study information

Scientific title

Acronym

Study hypothesis

To demonstrate that sedation has no effect on the validity of diagnostic lumbar 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 low back pain

Intervention

Intravenous injection of sodium chloride solution, midazolam, or fentanyl prior to lumbar facet joint nerve blocks under fluoroscopy.

Intervention type

Drug

Phase

Not Specified

Drug names

Sodium chloride solution, midazolam, or fentanyl

Primary outcome measures

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 measures

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.

Overall trial start date

02/02/2004

Overall trial end date

30/06/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180 subjects, randomized into 3 groups with equal distribution

Participant 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

Recruitment start date

02/02/2004

Recruitment end date

30/06/2004

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

http://www.thepainmd.com

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

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/16858466

Publication citations

  1. Results

    Manchikanti L, Pampati V, Damron KS, McManus CD, Jackson SD, Barnhill RC, Martin JC, A randomized, prospective, double-blind, placebo-controlled evaluation of the effect of sedation on diagnostic validity of cervical facet joint pain., Pain Physician, 2004, 7, 3, 301-309.

Additional files

Editorial Notes