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 or 13-gauge vertebroplasty needle introduced into the vertebral body with unipedicular or bipedicular technique with fluoroscopic guidance, using an AVAMAX kit (CareFusion Corporation). Aimed to fill vertebral body with PMMA from superior to inferior endplate, mid-pedicle to mid-pedicle in frontal projection, and from anterior cortex to posterior third of vertebral body (mean 7.5 ml [SD 2.8])
Sham vertebroplastySubcutaneous lidocaine but not periosteal numbing. Manual skin pressure and regular tapping on the needle was done, mimicking vertebroplasty needle advanced, with conversation about PMMA mixing and injection to suggest vertebroplasty was being done.

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainPain intensity (mean change from baseline [SD], 0 to 10 NRS)
  • All Participants
  • 2 (weeks)
  • 1 (month)
  • 3 (months)
  • 6 (months)
  • 3 (days)
ContinuousPainPain intensity (mean [SD], 0 to 100 VAS converted to 0 to 10 scale)
  • All Participants
  • 2 (weeks)
  • 6 (months)
ContinuousFunctionRDQ (mean change from baseline [SD], 0 to 24 scale)
  • All Participants
  • 2 (weeks)
  • 1 (month)
  • 3 (months)
  • 6 (months)
  • 3 (days)
CategoricalHarmsMortality
  • All Participants
  • 6 (months)
CategoricalHarmsIncident vertebral compression fracture
  • All Participants
  • 6 (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

Categorical


Harms (Mortality)

All Participants
Descriptive StatisticsBetween Arm Comparisons
VertebroplastySham vertebroplasty
6 (months)
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
6 (months)
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 change from baseline [SD], 0 to 10 NRS))

All Participants
Descriptive StatisticsBetween Arm Comparisons
VertebroplastySham vertebroplasty
2 (weeks)
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)
3 (days)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
VertebroplastySham vertebroplasty

Pain (Pain intensity (mean [SD], 0 to 100 VAS converted to 0 to 10 scale))

All Participants
Descriptive StatisticsBetween Arm Comparisons
VertebroplastySham vertebroplasty
2 (weeks)
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)
Within Arm ComparisonsNet Comparisons
VertebroplastySham vertebroplasty

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

All Participants
Descriptive StatisticsBetween Arm Comparisons
VertebroplastySham vertebroplasty
2 (weeks)
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)
3 (days)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
VertebroplastySham vertebroplasty