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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN76376497

Enrollment

Registered

2005-06-22

Start date

2004-05-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back pain Musculoskeletal Diseases Back pain

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Not provided at time of registration	—

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026