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 puncture needle placed transpedicularly in the fractured vertebral body under fluoroscopic monitoring; PMMA injected into the fractured vertebra with the fluoroscopic control (mean 4.5 [SD 1.2] ml per vertebral body); CT scan performed to identity cement distribution and leakage. |
| Usual care | Bed rest for 2 weeks, then patients encouraged to stand and walk with brace and assistance. NSAIDs with additional analgesics (e.g. tramadol and morphine) added if needed. Physical therapy initiated 2 weeks after diagnosis. |
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 (week)
- 1 (month)
- 3 (months)
- 6 (months)
- 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) | ||
| Continuous | Function | ODI (mean [SD], 0 to 100 scale) | ||
| Categorical | Harms | Incident vertebral 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 (Incident vertebral fracture)
| 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 | ||||
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) | |||||
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 | 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) | |||||
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) | |||||
| Within Arm Comparisons | Net Comparisons | ||||
| Vertebroplasty | Usual care | ||||