Condition category
Musculoskeletal Diseases
Date applied
27/09/2005
Date assigned
17/11/2005
Last edited
02/10/2008
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 #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 measures

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

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

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/16858481

Publication citations

  1. 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.

Additional files

Editorial Notes