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
Occipital nerve stimulation, adjustableor 2 leads implanted subcutaneously superficial to the fascia and muscle layer at C1 level; pulse frequency 3 to 130 Hz, pulse width 60 to 450 μs, pulse amplitude 0 to 10.5 V; parameters adjustable by patient to minimize pain
Occipital nerve stimulation, presetAs above, but stimulator preset to 1 minute per day stimulation
Usual careND

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainPain (mean change from baseline [SD], 0 to 10 scale)
  • All Participants
  • 3 (months)
ContinuousFunctionFunctional disability (mean change from baseline [SD], scale not reported)
  • 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 change from baseline [SD], 0 to 10 scale))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Occipital nerve stimulation, adjustableOccipital nerve stimulation, presetUsual care
3 (months)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Occipital nerve stimulation, adjustableOccipital nerve stimulation, presetUsual care

Function (Functional disability (mean change from baseline [SD], scale not reported))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Occipital nerve stimulation, adjustableOccipital nerve stimulation, presetUsual care
3 (months)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Occipital nerve stimulation, adjustableOccipital nerve stimulation, presetUsual care