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
Pulsed radiofrequency denervation of dorsal root gangliaThermocouple electrode (CSK, 20 cm length with 10 mm active tip) placed perpendicular to the dorsal root ganglion under fluoroscopy. Motor and sensory stimulation at 2 and 50 Hz to confirmed electrode tip proximity to dorsal root ganglia with presence of ipsilateral lower limb muscle contractions and paraesthesia at <0.5 V. Pulsed radiofrequency (NeuroTherm NT1100, St. Jude Medical, Inc., Saint Paul, MN, United States) of the dorsal root ganglia L4, L5, and S1 administered with 4 2 minute cycles using 2 Hz stimulation at 45 V unilaterally or bilaterally, with the cannulae tip temperature not exceeding 42°C.
Continuous radiofrequency denervation of medial branchAs for pulsed radiofrequency, except electrode was placed parallel to the medial dorsal branch (junction of the superior articular process and the transverse process where the medial dorsal branch is, without the electrode tip projecting past the ventral border of the facet column); absence of ipsilateral lower limb muscle contractions and paresthesia on stimulation; and continuous radiofrequency performed at L3 to 4, L4 to 5 and L5-S1 levels at 85°C for 90 seconds with 3 lesions at each level (2 mm intervals between lesions)
Sham radiofrequency denervationAs above, except radiofrequency generator switched on but did not delivering current to the thermocouple electrode.

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainVAS 0 to 10, mean change (SD)
  • All Participants
  • 3 (months)
  • 6 (months)
  • 1 (year)
  • 2 (years)
  • 3 (years)
ContinuousFunctionODI 0 to 100, mean change (SD)
  • All Participants
  • 3 (months)
  • 6 (months)
  • 1 (year)
  • 2 (years)
  • 3 (years)

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 (VAS 0 to 10, mean change (SD))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Pulsed radiofrequency denervation of dorsal root gangliaContinuous radiofrequency denervation of medial branchSham radiofrequency denervation
3 (months)
Mean
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
6 (months)
Mean
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
1 (year)
Mean
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
2 (years)
Mean
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 (years)
Mean
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Pulsed radiofrequency denervation of dorsal root gangliaContinuous radiofrequency denervation of medial branchSham radiofrequency denervation

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

All Participants
Descriptive StatisticsBetween Arm Comparisons
Pulsed radiofrequency denervation of dorsal root gangliaContinuous radiofrequency denervation of medial branchSham radiofrequency denervation
3 (months)
Mean
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
6 (months)
Mean
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
1 (year)
Mean
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
2 (years)
Mean
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 (years)
Mean
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Pulsed radiofrequency denervation of dorsal root gangliaContinuous radiofrequency denervation of medial branchSham radiofrequency denervation