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 needle inserted into the vertebral body via a unilateral parapedicular approach in 35 patients (87.5%) and via a bilateral transpedicular approach in 5 patients (12.5%). A bilateral transpedicular approach was used only if there was inadequate instillation of cement with the unilateral approach under fluoroscopy. A PMMA mixture was injected into the vertebral body (mean 3.5 ml for 1 level fracture and 5 ml for multilevel fractures)
Usual careAcetaminophen 250 mg with codeine twice daily, ibuprofen 400 mg twice daily, calcium 1000 mg daily, vitamin D 400 IU daily, alendronate 70 mg orally once weekly, and calcitonin 200 IU daily

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)
  • 2 (months)
  • 6 (months)
  • 1 (year)
  • 2 (years)
  • 3 (years)
ContinuousFunctionODI (mean [SD], 0 to 100 scale)
  • All Participants
  • 1 (week)
  • 2 (months)
  • 6 (months)
  • 1 (year)
  • 2 (years)
  • 3 (years)
CategoricalHarmsMortality
  • All Participants
  • 1 (year)
CategoricalHarmsNew fracture
  • All Participants
  • 2 (years)

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
VertebroplastyUsual care
1 (year)
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
VertebroplastyUsual care

Harms (New fracture)

All Participants
Descriptive StatisticsBetween Arm Comparisons
VertebroplastyUsual care
2 (years)
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
VertebroplastyUsual care

Continuous


Pain (Pain intensity (mean [SD], 0 to 10 VAS))

All Participants
Descriptive StatisticsBetween Arm Comparisons
VertebroplastyUsual care
1 (week)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
2 (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)
2 (years)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 (years)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
VertebroplastyUsual care

Function (ODI (mean [SD], 0 to 100 scale))

All Participants
Descriptive StatisticsBetween Arm Comparisons
VertebroplastyUsual care
1 (week)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
2 (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)
2 (years)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 (years)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
VertebroplastyUsual care