Status:
COMPLETED
Effect of Nitrous Oxide in Treating Neuropathic Pain: A Study in Chronic Low Back Pain Patients
Lead Sponsor:
The Cleveland Clinic
Conditions:
Low Back Pain
Radiating Pain
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Epidural injection will be completed under fluoroscopy and all patients will receive 1-4 mg of Midazolam for relaxation before procedure and, if needed, 50-100 mcg of Fentanyl intravenous (IV). Radiop...
Eligibility Criteria
Inclusion
- 18 to 80 years old at time of the first procedure
- Male or female
- History of chronic low back pain for longer than 6 months due to radiculopathy, symptomatic spinal canal stenosis, disc prolapse, postlaminectomy syndrome
- magnetic resonance imaging or electromyographic evidence of nerve root damage
- Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score of \>12
- No or minimal evidence of facet joint pathology
Exclusion
- Known contraindications for epidural injection
- Patients with ongoing workers' compensation claims
- unstable or heavy opioid use (400 mg of morphine equivalents daily),
- psychiatric disorders
- medical illness, including conditions that could interfere with the interpretation of the outcome assessments
- pregnant or lactating women
- Current or recent drug abuse (within past 6 months).
- Patient refuses regional analgesia.
- Alcohol or drug abuse
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01172600
Start Date
January 1 2011
End Date
March 1 2013
Last Update
October 17 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195