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 denervationFor S1 to S3 lateral branches, 17-gauge, 75-mm cooled electrodes with 4 mm active tips (Baylis Medical, Montreal, Quebec, Canada) placed between 3 and 5 mm from the lateral border of the sacral foramina at predesignated positions. Placement confirmed with electrostimulation (concordant sensation at 0.5 V or less). Administered 0.5 ml 2% lidocaine, followed by water-cooled radiofrequency heating system (Pain Management SInergy System; Baylis Medical) and generator (PMG-115-TD, V2.0A; Baylis Medical) applied for 2 minutes at 60°C, with target tissue heated to 75°C (resulting lesion diameter 8 to 10 mm). -For L4 and L5 dorsal rami, conventional radiofrequency with 22-gauge SMK-C10 cannula with 5-mm active tips inserted parallel to the course of the nerve until bone contacted. Placement confirmed with electrostimulation at 50 Hz, with concordant sensation achieved at ≤0.5 V; absence of leg contractions verified with stimulation at 2 Hz up to ≤2 V. Administered 0.5 ml 2% lidocaine followed by 90 second, 80°C radiofrequency lesion
Sham radiofrequencyElectrodes positioned similarly and electrostimulation performed in identical manner. Administered 0.5 2% lidocaine but no current administered (procedure time similar to active treatment). Offered crossover to conventional (non-cooled) radiofrequency denervation as described above.

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainNRS 0 to 10, mean (SD)
  • All Participants
  • 1 (month)
  • 3 (months)
ContinuousFunctionODI (mean [SD], 0 to 100 scale)
  • All Participants
  • 1 (month)
  • 3 (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 (SD))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Cooled radiofrequency denervationSham radiofrequency
1 (month)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 (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 denervationSham radiofrequency

Function (ODI (mean [SD], 0 to 100 scale))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Cooled radiofrequency denervationSham radiofrequency
1 (month)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 (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 denervationSham radiofrequency