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 | 11-gauge needle inserted into the vertebral body via a unilateral parapedicular approach in 35 patients (87.5%) and via a bilateral transpedicular approach in 5 patients (12.5%). A bilateral transpedicular approach was used only if there was inadequate instillation of cement with the unilateral approach under fluoroscopy. A PMMA mixture was injected into the vertebral body (mean 3.5 ml for 1 level fracture and 5 ml for multilevel fractures) |
| Usual care | Acetaminophen 250 mg with codeine twice daily, ibuprofen 400 mg twice daily, calcium 1000 mg daily, vitamin D 400 IU daily, alendronate 70 mg orally once weekly, and calcitonin 200 IU daily |
Arm Details
N/A
Sample Characteristics
N/A
Outcomes
- All Participants
- 1 (week)
- 2 (months)
- 6 (months)
- 1 (year)
- 2 (years)
- 3 (years)
- All Participants
- 1 (week)
- 2 (months)
- 6 (months)
- 1 (year)
- 2 (years)
- 3 (years)
- All Participants
- 1 (year)
- All Participants
- 2 (years)
| Type | Domain | Specific measurement (i.e., tool/definition/specific outcome) | Populations | Timepoints |
|---|---|---|---|---|
| Continuous | Pain | Pain intensity (mean [SD], 0 to 10 VAS) | ||
| Continuous | Function | ODI (mean [SD], 0 to 100 scale) | ||
| Categorical | Harms | Mortality | ||
| Categorical | Harms | New 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 | Usual care | ||||
1 (year) | |||||
| Events | Odds Ratio (OR) | ||||
| Percentage | 95% CI low (OR) | ||||
| 95% CI high (OR) | |||||
| p value | |||||
| Within Arm Comparisons | Net Comparisons | ||||
| Vertebroplasty | Usual care | ||||
Harms (New fracture)
| Descriptive Statistics | Between Arm Comparisons | ||||
|---|---|---|---|---|---|
| Vertebroplasty | Usual care | ||||
2 (years) | |||||
| Events | Odds Ratio (OR) | ||||
| Percentage | 95% CI low (OR) | ||||
| 95% CI high (OR) | |||||
| p value | |||||
| Within Arm Comparisons | Net Comparisons | ||||
| Vertebroplasty | Usual care | ||||
Continuous
Pain (Pain intensity (mean [SD], 0 to 10 VAS))
| Descriptive Statistics | Between Arm Comparisons | ||||
|---|---|---|---|---|---|
| Vertebroplasty | Usual care | ||||
1 (week) | |||||
| Mean | Mean Difference (MD) | ||||
| SD | 95% CI low (MD) | ||||
| 95% CI high (MD) | |||||
| SD (MD) | |||||
| p value (MD) | |||||
2 (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) | |||||
2 (years) | |||||
| Mean | Mean Difference (MD) | ||||
| SD | 95% CI low (MD) | ||||
| 95% CI high (MD) | |||||
| SD (MD) | |||||
| p value (MD) | |||||
3 (years) | |||||
| Mean | Mean Difference (MD) | ||||
| SD | 95% CI low (MD) | ||||
| 95% CI high (MD) | |||||
| SD (MD) | |||||
| p value (MD) | |||||
| Within Arm Comparisons | Net Comparisons | ||||
| Vertebroplasty | Usual care | ||||
Function (ODI (mean [SD], 0 to 100 scale))
| Descriptive Statistics | Between Arm Comparisons | ||||
|---|---|---|---|---|---|
| Vertebroplasty | Usual care | ||||
1 (week) | |||||
| Mean | Mean Difference (MD) | ||||
| SD | 95% CI low (MD) | ||||
| 95% CI high (MD) | |||||
| SD (MD) | |||||
| p value (MD) | |||||
2 (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) | |||||
2 (years) | |||||
| Mean | Mean Difference (MD) | ||||
| SD | 95% CI low (MD) | ||||
| 95% CI high (MD) | |||||
| SD (MD) | |||||
| p value (MD) | |||||
3 (years) | |||||
| Mean | Mean Difference (MD) | ||||
| SD | 95% CI low (MD) | ||||
| 95% CI high (MD) | |||||
| SD (MD) | |||||
| p value (MD) | |||||
| Within Arm Comparisons | Net Comparisons | ||||
| Vertebroplasty | Usual care | ||||