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
VertebroplastyPeriosteum of the posterior lamina infiltrated with local anesthetic, 13-gauge needle was placed posterolaterally relative to the eye of the pedicle and guided into the anterior two-thirds of the fractured vertebral body and approximately 3 ml prepared PMMA slowly injected into the vertebral body (mean 2.8 ml [SD 1.2]); satisfactory infiltration of the vertebral body confirmed radiographically
Sham vertebroplastyPeriosteum of the posterior lamina infiltrated with local anesthetic, 13-gauge needle inserted as for vertebroplasty, then the central sharp stylet was replaced with a blunt stylet; to simulate vertebroplasty, the vertebral body was gently tapped; PMMA was prepared so that its smell permeated the room

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainOverall pain (mean change from baseline [SD], 0 to 10 VAS)
  • All Participants
  • 1 (week)
  • 1 (month)
  • 3 (months)
  • 6 (months)
CategoricalHarmsIncident clinical vertebral fracture
  • All Participants
  • 6 (months)
CategoricalHarmsMortality
  • All Participants
  • 6 (months)
ContinuousFunctionModified RDQ (mean change from baseline [SD], 0 to 23 scale)
  • All Participants
  • 1 (week)
  • 1 (month)
  • 3 (months)
  • 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 (Incident clinical vertebral 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

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

Continuous


Pain (Overall pain (mean change from baseline [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)
Within Arm ComparisonsNet Comparisons
VertebroplastySham vertebroplasty

Function (Modified RDQ (mean change from baseline [SD], 0 to 23 scale))

All Participants
Descriptive StatisticsBetween Arm Comparisons
VertebroplastySham vertebroplasty
1 (week)
adjusted mean difference
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
95% CI low
SD (MD)
95% CI high
p value (MD)
1 (month)
adjusted mean difference
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
95% CI low
SD (MD)
95% CI high
p value (MD)
3 (months)
adjusted mean difference
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
95% CI low
SD (MD)
95% CI high
p value (MD)
6 (months)
adjusted mean difference
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
95% CI low
SD (MD)
95% CI high
p value (MD)
Within Arm ComparisonsNet Comparisons
VertebroplastySham vertebroplasty