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
VertebroplastySubcutaneous tissues overlying pedicle infiltrated with 1% lidocaine and periosteum of pedicles infiltrated with 0.25% bupivacaine. 11- or 13-gauge needles passed into the central aspect of the target vertebra or vertebrae. Barium opacified PMMA was prepared on the bench and infused under constant lateral fluoroscopy into the vertebral body. Infusion stopped when the PMMA reached to the posterior aspect of the vertebral body or entered an extra osseous space (mean PMMA volume 2.6 ml).
Sham vertebroplastySubcutaneous tissues overlying pedicle infiltrated with 1% lidocaine and periosteum of pedicles infiltrated with 0.25% bupivacaine. Verbal and physical cues, such as pressure on the patient’s back, then methacrylate monomer opened to simulate the odor associated with mixing of PMMA, but needle not placed and PMMA not infused

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
  • 2 (weeks)
  • 1 (month)
  • 3 (months)
  • 6 (months)
  • 1 (year)
  • 3 (days)
ContinuousFunctionModified RDQ (mean [SD], 0 to 23 scale)
  • All Participants
  • 2 (weeks)
  • 1 (month)
  • 3 (months)
  • 6 (months)
  • 1 (year)
  • 3 (days)

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

Continuous


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

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)
1 (year)
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

Function (Modified RDQ (mean [SD], 0 to 23 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)
1 (year)
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