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 L5 dorsal ramus, introducer needle placed under fluoroscopy to junction of S1 superior articular process and sacral ala; stylet replaced with SInergy Probe (Kimberly Clark Health Care). Accurate electrode placement confirmed and 0.5 cc 2% lidocaine and 0.75% bupivacaine injected, then radiofrequency energy delivered for 150 seconds at 60°C. For S1 to S3 lateral branch sites, 27-gauge needle placed under fluoroscopy 7 mm lateral to S1 posterior sacral foramen for localization. Introducer advanced and 17-gauge, 75-mm cooled electrode with 4 mm active tip (Kimberly Clark Health Care) inserted 2 mm from surface of the sacrum. Impedance confirmed at 100 to 500 W. Radiofrequency lesioning performed as described for L5 dorsal ramus. To form an arc-shaped treated area lateral to the S1 posterior sacral foramen, 2 additional lesions were created at that level. Similar technique used for S2 and S3 sites (2 lesions at S3). Post-lesioning, 1 cc of a 1:1 mixture of 2% lidocaine and 0.75% bupivacaine administered.
Sham radiofrequencyNeedle placement as described for A, but no cooled radiofrequency lesioning performed

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
  • 1 (month)
  • 3 (months)
ContinuousPainODI 0 to 100, mean change (SD)
  • 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 change (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

Pain (ODI 0 to 100, mean change (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