Extraction form for project: Interventional Treatments for Acute and Chronic Pain: Systematic Review
Design Details
1. Trial Intervention
Input which intervention is being studied
Single Choice Vertebroplasty Kyphoplasty Cooled radiofrequency ablation Pulsed radiofrequency ablation Platelet-rich plasma Intradiscal stem cell Intradiscal methylene blue Intradiscal ozone Sphenopalatine block Occipital nerve stimulation Piriformis injection Peripheral nerve stimulation |
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)
Single Choice Mean Median ND |
9. Pain Duration (Weeks)
10. Duration of Followup (Months)
Arm Details
N/A
Sample Characteristics
N/A
Outcome Details
N/A
Risk of Bias Assessment
1. What kind of study is this?
Single Choice RCT |
2. Randomization adequate?
Single Choice Yes No Unclear |
3. Allocation concealment adequate?
Single Choice Yes No Unclear |
4. Groups similar at baseline?
Single Choice Yes No Unclear No (pai No (pain) No (ODI) No (pain, EQ-5D) No (% female) |
5. Outcome assessors masked?
Single Choice Yes No Unclear No (except for safety) |
6. Care provider masked?
Single Choice Yes No Unclear |
7. Patient masked?
Single Choice Yes No Unclear |
8. Acceptable levels of overall attrition and between-group differences in attrition?
9. Intention-to-Treat (ITT) analysis?
Single Choice Yes No Unclear No (at 3 months and beyond, due to high crossover) |
10. Avoidance of selective outcomes reporting
Single Choice Yes No Unclear |
11. Quality rating
Single Choice Good Fair Poor |
Suggested Arms
Name | Description |
---|---|
Interventions and Comparisons | Add labels for the interventions and comparisons (typically Intervention A (treatment) and Intervention B (control)). |
Total | All Arms combined |
Please see downloadable data for more
Suggested Outcomes
Type | Domain | Specific measurement (i.e., tool/definition/specific outcome) |
---|---|---|
Categorical | Function | RDQ improvement >=30% |
Categorical | Harms | |
Categorical | Pain | NRS <4 (0 to 10 scale) |
Categorical | Pain | Pain improvement >=30% |
Categorical | Pain | Perceived pain moderately or a great deal better |
Categorical | Pain | Successful outcome defined as ≥50% improvement in pain, positive Global Perceived Effect, and ≥10-point improvement in ODI or ≥4 point improvement in ODI and >20% reduction in opioid use or complete cessation of nonopioid analgesic |
Categorical | Pain | Vertebral pain <4 on 0 to 10 VAS |
Continuous | Function | |
Continuous | Function | FRI 0 to 100, mean difference (95% CI) |
Continuous | Function | Modified RDQ (mean [SD], 0 to 23 scale) |
Continuous | Function | Modified RDQ (mean change from baseline [SD], 0 to 23 scale) |
Continuous | Function | ODI (mean [SD], 0 to 100 scale) |
Continuous | Function | ODI (mean change from baseline [SD], 0 to 100 scale) |
Continuous | Function | ODI LSM (95% CI) |
Continuous | Function | RDQ (mean [SD], 0 to 24 scale) |
Continuous | Function | RDQ (mean change from baseline [SD], 0 to 24 scale) |
Continuous | Function (Change) | |
Continuous | Pain | |
Continuous | Pain | Dallas Pain Questionnaire, anxiety and depression (mean [SD], 0 to 100 scale) |
Continuous | Pain | Dallas Pain Questionnaire, daily activities (mean [SD], 0 to 100 scale) |
Continuous | Pain | NRS 0 to 10 worst pain, mean difference (95% CI) |
Continuous | Pain | Overall pain (mean change from baseline [SD], 0 to 10 VAS) |
Continuous | Pain | Pain (mean [SD] improvement from baseline, 0 to 10 VAS) |
Continuous | Pain | Pain at rest (mean [SD], 0 to 10 VAS) |
Continuous | Pain | Pain intensity (mean [SD], 0 to 10 NRS) |
Continuous | Pain | Pain intensity (mean [SD], 0 to 10 VAS) |
Continuous | Pain | Pain intensity (mean [SD], 0 to 100 VAS converted to 0 to 10 scale) |
Continuous | Pain | Pain intensity (mean change from baseline [SD], 0 to 10 NRS) |
Continuous | Pain | VAS LSM (95% CI) |
Continuous | Pain (Change) |
Please see downloadable data for more