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
Peripheral nerve stimulationLead placement under fluoroscopic or ultrasound guidance, placement confirmed with test stimulation; stimulation parameters phase duration 70 to 500 m/sec, pulse rate 1 to 200 Hz, time on ranged from 10 minutes to 12 hours (mean 6 hours per day at 3-month study visit). Typical settings were 200 m/sec; 100 Hz; amplitude set for paresthesia
Sham stimulationStimulator placed but no therapeutic stimulation provided

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainPain (mean % reduction [SD])
  • All Participants
  • 12 (months)
ContinuousFunctionSF-12 0 to 100, mean change (SD)
  • All Participants
  • 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 (Pain (mean % reduction [SD]))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Peripheral nerve stimulationSham stimulation
12 (months)
mean change
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Peripheral nerve stimulationSham stimulation

Function (SF-12 0 to 100, mean change (SD))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Peripheral nerve stimulationSham stimulation
3 (months)
mean change
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Peripheral nerve stimulationSham stimulation