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
Vertebroplasty11-gauge needles inserted into the fractured vertebral body via the pedicles under fluoroscopic guidance and a biopsy specimen was taken, then 2 to 4 ml of bone cement was injected into fracture vertebral body.
Sham vertebroplastySame procedure, with bone cement mixed to create the odor similar to a PVP-procedure; lidocaine 2 ml (10 mg/ml) injected into fractured vertebral body.

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainPain at rest (mean [SD], 0 to 10 VAS)
  • All Participants
  • 1 (week)
  • 4 (weeks)
  • 1 (year)
  • 12 (weeks)

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 at rest (mean [SD], 0 to 10 VAS))

All Participants
Descriptive StatisticsBetween Arm Comparisons
VertebroplastySham vertebroplasty
1 (week)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
4 (weeks)
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)
12 (weeks)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
VertebroplastySham vertebroplasty