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 | Periosteum 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 vertebroplasty | Periosteum 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
- All Participants
- 1 (week)
- 1 (month)
- 3 (months)
- 6 (months)
- All Participants
- 6 (months)
- All Participants
- 6 (months)
- All Participants
- 1 (week)
- 1 (month)
- 3 (months)
- 6 (months)
| Type | Domain | Specific measurement (i.e., tool/definition/specific outcome) | Populations | Timepoints |
|---|---|---|---|---|
| Continuous | Pain | Overall pain (mean change from baseline [SD], 0 to 10 VAS) | ||
| Categorical | Harms | Incident clinical vertebral fracture | ||
| Categorical | Harms | Mortality | ||
| Continuous | Function | Modified RDQ (mean change from baseline [SD], 0 to 23 scale) |
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)
| Descriptive Statistics | Between Arm Comparisons | ||||
|---|---|---|---|---|---|
| Vertebroplasty | Sham vertebroplasty | ||||
6 (months) | |||||
| Events | Odds Ratio (OR) | ||||
| Percentage | 95% CI low (OR) | ||||
| 95% CI high (OR) | |||||
| p value | |||||
| Within Arm Comparisons | Net Comparisons | ||||
| Vertebroplasty | Sham vertebroplasty | ||||
Harms (Mortality)
| Descriptive Statistics | Between Arm Comparisons | ||||
|---|---|---|---|---|---|
| Vertebroplasty | Sham vertebroplasty | ||||
6 (months) | |||||
| 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 (Overall pain (mean change from baseline [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) | |||||
| Within Arm Comparisons | Net Comparisons | ||||
| Vertebroplasty | Sham vertebroplasty | ||||
Function (Modified RDQ (mean change from baseline [SD], 0 to 23 scale))
| Descriptive Statistics | Between Arm Comparisons | ||||
|---|---|---|---|---|---|
| Vertebroplasty | Sham 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 Comparisons | Net Comparisons | ||||
| Vertebroplasty | Sham vertebroplasty | ||||