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 stimulationPercutaneous quadripolar lead implanted under local anesthetic and mild sedation. Permanent neurostimulator implanted; stimulation at frequency of 50 Hz, pulse width 330 to 450 μs, maximum stimulation amplitude 10.5 V.
Sham occipital nerve stimulationAs above, but internal neurostimulator was inactive (turned off)

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainPain (median [IQR], 0 to 10 scale)
  • All Participants
  • first crossover period
ContinuousPainHeadache days/week (median [IQR])
  • All Participants
  • first crossover period

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 (median [IQR], 0 to 10 scale))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Occipital nerve stimulationSham occipital nerve stimulation
first crossover period
Median
Mean Difference (MD)
25th percentile
95% CI low (MD)
75th percentile
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Occipital nerve stimulationSham occipital nerve stimulation

Pain (Headache days/week (median [IQR]))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Occipital nerve stimulationSham occipital nerve stimulation
first crossover period
Median
Mean Difference (MD)
25th percentile
95% CI low (MD)
75th percentile
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Occipital nerve stimulationSham occipital nerve stimulation