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 NameArm Description
Oxygen-ozone, corticosteroid, and local anesthetic injectionUnder fluoroscopic guidance via posterolateral extrapedicular approach, 5 to 7 ml O2 to O3 (ozone concentration 28 μg/ml) intradiscal (mean 5.8 ml) and 5 to 7 ml O2 to O3 intraforaminal (mean 6.5 ml) + 2 ml 40 mg/ml triamcinolone acetonide (1 ml intradiscal and 1 ml intraforaminal) + 2 to 4 ml 2% ropivacaine intraforaminal and intradiscal injection
Corticosteroid and local anesthetic injectionAs above, without O2 to O3
Sham injection1.5 ml 1% lidocaine alone

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousFunctionODI 0 to 100, mean change (SD)
  • All Participants
  • 2 (weeks)
  • 3 (months)
  • 6 (months)

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


Function (ODI 0 to 100, mean change (SD))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Oxygen-ozone, corticosteroid, and local anesthetic injectionCorticosteroid and local anesthetic injectionSham injection
2 (weeks)
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 ComparisonsNet Comparisons
Oxygen-ozone, corticosteroid, and local anesthetic injectionCorticosteroid and local anesthetic injectionSham injection