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 | Subcutaneous 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 vertebroplasty | Subcutaneous 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
- All Participants
- 2 (weeks)
- 1 (month)
- 3 (months)
- 6 (months)
- 1 (year)
- 3 (days)
- All Participants
- 2 (weeks)
- 1 (month)
- 3 (months)
- 6 (months)
- 1 (year)
- 3 (days)
| Type | Domain | Specific measurement (i.e., tool/definition/specific outcome) | Populations | Timepoints |
|---|---|---|---|---|
| Continuous | Pain | Pain intensity (mean [SD], 0 to 10 VAS) | ||
| Continuous | Function | Modified RDQ (mean [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
Continuous
Pain (Pain intensity (mean [SD], 0 to 10 VAS))
| Descriptive Statistics | Between Arm Comparisons | ||||
|---|---|---|---|---|---|
| Vertebroplasty | Sham 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 Comparisons | Net Comparisons | ||||
| Vertebroplasty | Sham vertebroplasty | ||||
Function (Modified RDQ (mean [SD], 0 to 23 scale))
| Descriptive Statistics | Between Arm Comparisons | ||||
|---|---|---|---|---|---|
| Vertebroplasty | Sham 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 Comparisons | Net Comparisons | ||||
| Vertebroplasty | Sham vertebroplasty | ||||