Extraction form for project: Interventional Treatments for Acute and Chronic Pain: Systematic Review

Design Details

1. Trial Intervention
Input which intervention is being studied
2. Trial Name
3. Setting
Country
4. Study Design
5. Mean Age (Years)
Input the mean age for the entire sample
6. Percent Female
Input the whole number here for the entire study sample - no need to add %
7. Number Randomized
8. Pain Duration Measure (Mean, Median)
9. Pain Duration (Weeks)
10. Duration of Followup (Months)

Arms

Arm NameArm Description
Cooled radiofrequency denervation17-gauge cooled radiofrequency ablation introducer needle placed at medial branch nerve targets, 18-gauge cooled radiofrequency ablation probe with a 4 mm active tip (Coolief Cooled Radiofrequency Kit, Halyard Health, Alpharetta, Georgia) with 2 mm gap between the electrode tip and the base of the superior articular process. Motor testing (2.0 V, 2 Hz) performed at each target site. Administered 1 ml of 2% lidocaine through the introducer needle, followed by cooled radiofrequency ablation lesioning for 165 seconds at each site, generator temperature set to 60°C (intralesional temperature >80°C). Administered 0.5 ml 0.5% bupivacaine following procedure
Conventional radiofrequency denervation20-gauge traditional radiofrequency ablation probes with 10 mm active tips (Baylis Medical, Montreal, Canada) placed at medial branch nerve targets using parallel technique. Motor testing and local anesthetic as described for cooled radiofrequency. Radiofrequency lesioning performed for 90 seconds at 80°C at each target site.

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainNRS 0 to 10, mean change (SD)
  • All Participants
  • 6 (months)
ContinuousFunctionODI 0 to 100, mean change (SD)
  • All Participants
  • 6 (months)

Outcome Details

N/A

Risk of Bias Assessment

1. What kind of study is this?
2. Randomization adequate?
3. Allocation concealment adequate?
4. Groups similar at baseline?
5. Outcome assessors masked?
6. Care provider masked?
7. Patient masked?
8. Acceptable levels of overall attrition and between-group differences in attrition?
9. Intention-to-Treat (ITT) analysis?
10. Avoidance of selective outcomes reporting
11. Quality rating

Results

Continuous


Pain (NRS 0 to 10, mean change (SD))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Cooled radiofrequency denervationConventional radiofrequency denervation
6 (months)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Cooled radiofrequency denervationConventional radiofrequency denervation

Function (ODI 0 to 100, mean change (SD))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Cooled radiofrequency denervationConventional radiofrequency denervation
6 (months)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Cooled radiofrequency denervationConventional radiofrequency denervation