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 stimulationLeads placed on either side of midline caudally along the nerve or, more commonly, perpendicular to the course of the occipital nerves at the level of the craniocervical junction. Stimulation parameters not reported ("programmed for appropriate stimulation").
Sham occipital nerve stimulationLeads placed as above, but no stimulation administered. Mekhail, 2017 (single center from Silberstein 2012) RCT 12 weeks Single center from the Silberstein, 2012 study Leads placed as above, but no stimulation administered.

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainHeadache days, mean change (SD)
  • All Participants
  • 3 (months)
ContinuousPainMIDAS score (>20=severe disability), mean (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 (Headache days, mean change (SD))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Occipital nerve stimulationSham occipital nerve stimulation
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 stimulationSham occipital nerve stimulation

Pain (MIDAS score (>20=severe disability), mean (SD))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Occipital nerve stimulationSham occipital nerve stimulation
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 stimulationSham occipital nerve stimulation