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
Intradiscal methylene blue1 ml (10 mg/ml) methylene blue + 0.5 ml lidocaine hydrochloride 2%, and 0.5 ml contrast dye injected at 0.02 ml/sec in symptomatic disc(s) and ≥1 adjacent control disc
Sham intradiscal therapy1 ml saline + 0.5 ml lidocaine hydrochloride 2%, and 0.5 ml contrast dye injected as above

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainNRS 0 to 10, mean difference in mean change (95% CI)
  • All Participants
  • 6 (weeks)
  • 3 (months)
  • 6 (months)
ContinuousFunctionODI 0 to 100, mean change (SD)
  • All Participants
  • 6 (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


Pain (NRS 0 to 10, mean difference in mean change (95% CI))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intradiscal methylene blueSham intradiscal therapy
6 (weeks)
mean difference in mean change
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)
mean difference in mean change
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)
mean difference in mean change
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 ComparisonsNet Comparisons
Intradiscal methylene blueSham intradiscal therapy

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

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intradiscal methylene blueSham intradiscal therapy
6 (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
Intradiscal methylene blueSham intradiscal therapy