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
KyphoplastyUse of introducer instruments, inflatable bone tamps, and PMMA by a percutaneous, bilateral, transpedicular, or extrapedicular approach (mean PMMA volume not reported).
Usual careAnalgesics, bed rest, back braces, physiotherapy, rehabilitation programs, and walking aids according to standard practices of participating hospitals.

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)
ContinuousFunctionRDQ (mean [SD], 0 to 24 scale)
  • All Participants
  • 1 (month)
  • 3 (months)
  • 6 (months)
  • 1 (year)
CategoricalHarmsMortality
  • All Participants
  • 1 (year)
CategoricalHarmsNew or worsening 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
KyphoplastyUsual care
1 (year)
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
KyphoplastyUsual care

Harms (New or worsening fracture)

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

Continuous


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

All Participants
Descriptive StatisticsBetween Arm Comparisons
KyphoplastyUsual care
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)
Within Arm ComparisonsNet Comparisons
KyphoplastyUsual care

Function (RDQ (mean [SD], 0 to 24 scale))

All Participants
Descriptive StatisticsBetween Arm Comparisons
KyphoplastyUsual care
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)
Within Arm ComparisonsNet Comparisons
KyphoplastyUsual care