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 Name | Arm Description |
|---|---|
| Vertebroplasty | Bone biopsy needles at vertebral body positioned bilaterally, using standard transpedicular placements with local anesthetic (1% lidocaine into each pedicle followed by 0.25% ropivacaine) unless conscious sedation required (50 μg fentanyl in 22% of patients), PMMA injection stopped when cement leakage was noticed via CT (mean PMMA volume 5.1 ml [SD 1.8]). In participants with multiple fractures, all were treated. |
| Sham vertebroplasty | Stab incisions at level of the vertebral body, local anesthetic as above, PMMA prepared in close proximity to the participants to duplicate mixing sound and smell; simulated procedure using verbal and physical cues. |
Arm Details
N/A
Sample Characteristics
N/A
Outcomes
- All Participants
- 1 (week)
- 1 (month)
- 3 (months)
- 6 (months)
- 1 (year)
- 1 (day)
- All Participants
- 1 (year)
- All Participants
- 1 (year)
| Type | Domain | Specific measurement (i.e., tool/definition/specific outcome) | Populations | Timepoints |
|---|---|---|---|---|
| Continuous | Pain | Pain intensity (mean [SD], 0 to 10 VAS) | ||
| Categorical | Harms | Mortality | ||
| Categorical | Harms | Incident vertebral compression fracture |
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)
| Descriptive Statistics | Between Arm Comparisons | ||||
|---|---|---|---|---|---|
| Vertebroplasty | Sham vertebroplasty | ||||
1 (year) | |||||
| Events | Odds Ratio (OR) | ||||
| Percentage | 95% CI low (OR) | ||||
| 95% CI high (OR) | |||||
| p value | |||||
| Within Arm Comparisons | Net Comparisons | ||||
| Vertebroplasty | Sham vertebroplasty | ||||
Harms (Incident vertebral compression fracture)
| Descriptive Statistics | Between Arm Comparisons | ||||
|---|---|---|---|---|---|
| Vertebroplasty | Sham vertebroplasty | ||||
1 (year) | |||||
| Events | Odds Ratio (OR) | ||||
| Percentage | 95% CI low (OR) | ||||
| 95% CI high (OR) | |||||
| p value | |||||
| Within Arm Comparisons | Net Comparisons | ||||
| Vertebroplasty | Sham vertebroplasty | ||||
Continuous
Pain (Pain intensity (mean [SD], 0 to 10 VAS))
| Descriptive Statistics | Between Arm Comparisons | ||||
|---|---|---|---|---|---|
| Vertebroplasty | Sham 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) | |||||
1 (year) | |||||
| Mean | Mean Difference (MD) | ||||
| SD | 95% CI low (MD) | ||||
| 95% CI high (MD) | |||||
| SD (MD) | |||||
| p value (MD) | |||||
1 (day) | |||||
| Mean | Mean Difference (MD) | ||||
| SD | 95% CI low (MD) | ||||
| 95% CI high (MD) | |||||
| SD (MD) | |||||
| p value (MD) | |||||
| Within Arm Comparisons | Net Comparisons | ||||
| Vertebroplasty | Sham vertebroplasty | ||||