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
VertebroplastyBone biopsy needles at vertebral body positioned bilaterally, using standard transpedicular placements with local anesthetic (1% lidocaine into each pedicle followed by 0.25% ropivacaine) unless conscious sedation required (50 μg fentanyl in 22% of patients), PMMA injection stopped when cement leakage was noticed via CT (mean PMMA volume 5.1 ml [SD 1.8]). In participants with multiple fractures, all were treated.
Sham vertebroplastyStab incisions at level of the vertebral body, local anesthetic as above, PMMA prepared in close proximity to the participants to duplicate mixing sound and smell; simulated procedure using verbal and physical cues.

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainPain intensity (mean [SD], 0 to 10 VAS)
  • All Participants
  • 1 (week)
  • 1 (month)
  • 3 (months)
  • 6 (months)
  • 1 (year)
  • 1 (day)
CategoricalHarmsMortality
  • All Participants
  • 1 (year)
CategoricalHarmsIncident vertebral compression fracture
  • All Participants
  • 1 (year)

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

Categorical


Harms (Mortality)

All Participants
Descriptive StatisticsBetween Arm Comparisons
VertebroplastySham vertebroplasty
1 (year)
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
VertebroplastySham vertebroplasty

Harms (Incident vertebral compression fracture)

All Participants
Descriptive StatisticsBetween Arm Comparisons
VertebroplastySham vertebroplasty
1 (year)
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
VertebroplastySham vertebroplasty

Continuous


Pain (Pain intensity (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)
1 (month)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 (months)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
6 (months)
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)
1 (day)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
VertebroplastySham vertebroplasty