Condition category
Musculoskeletal Diseases
Date applied
21/06/2005
Date assigned
22/06/2005
Last edited
16/08/2011
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

7

Study information

Scientific title

Acronym

Study hypothesis

To demonstrate the lack of effect of sedation on the validity of diagnostic cervical and 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

Diagnostic

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Sodium chloride solution, midazolam and fentanyl

Primary outcome measures

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 trial start date

01/05/2004

Overall trial end date

31/10/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total of 60 patients, randomized into 3 groups with equal size

Participant 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

Recruitment start date

01/05/2004

Recruitment end date

31/10/2005

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

Institutional Review Board of Ambulatory Surgery Center (USA)

Sponsor details

2831 Lone Oak Road
Paducah
KY
42003
United States of America
+1 270 775 8373
painmgmt@apex.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

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

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16700280

Publication citations

  1. Results

    Manchikanti L, Pampati V, Damron KS, McManus CD, Jackson SD, Barnhill RC, Martin JC, The effect of sedation on diagnostic validity of facet joint nerve blocks: an evaluation to assess similarities in population with involvement in cervical and lumbar regions (ISRCTNo: 76376497)., Pain Physician, 2006, 9, 1, 47-51.

Additional files

Editorial Notes