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
Pulsed radiofrequency denervation22-gauge 10 cm SMK-C10 electrode, 2-mm active tip placed at angle between the superior articular process and transverse process for the segmental medial branches of lumbar nerve roots. Impedance verified at 300 to 700 Ohms and sensory stimulation (50 Hz) reproduced pain at <0.5 V and did not result in leg contractions at 1 V; contractions of the multifidus muscle observed between 0.3 and 0.5 V L1 to L3 or L3 to L5 treated; 0.5 ml 2% prilocaine followed with 2 Hz pulsed radiofrequency waves for 4 minutes (45 V) to a temperature of 42 degrees C.
Continuous radiofrequency denervationAs above, except used an electrode with 10-mm active tip and treated continuously for 90 seconds to 80 degrees C
Sham radiofrequency denervationElectrodes and thermocouple probes positioned similarly without switching on radiofrequency current, only 0.3 ml 0.5% bupivacaine injected

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainPain intensity (mean [SD], 0 to 10 VAS)
  • All Participants
  • 6 (months)
  • 1 (year)
ContinuousFunctionODI (mean [SD], 0 to 100 scale)
  • All Participants
  • 6 (months)
  • 1 (year)

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 (Pain intensity (mean [SD], 0 to 10 VAS))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Pulsed radiofrequency denervationContinuous radiofrequency denervationSham radiofrequency denervation
6 (months)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
1 (year)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Pulsed radiofrequency denervationContinuous radiofrequency denervationSham radiofrequency denervation

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

All Participants
Descriptive StatisticsBetween Arm Comparisons
Pulsed radiofrequency denervationContinuous radiofrequency denervationSham radiofrequency denervation
6 (months)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
1 (year)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Pulsed radiofrequency denervationContinuous radiofrequency denervationSham radiofrequency denervation