Design Details

1. Trial Intervention

Input which intervention is being studied


	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


	ND

3. Setting

Country


	U.S.

4. Study Design


	RCT

5. Mean Age (Years)

Input the mean age for the entire sample


	55.8

6. Percent Female

Input the whole number here for the entire study sample - no need to add %


	59

7. Number Randomized


	43

8. Pain Duration Measure (Mean, Median)


	Mean Median ND

9. Pain Duration (Weeks)


	ND

10. Duration of Followup (Months)


	6

Arms

Arm Name	Arm Description
Cooled radiofrequency denervation	17-gauge cooled radiofrequency ablation introducer needle placed at medial branch nerve targets, 18-gauge cooled radiofrequency ablation probe with a 4 mm active tip (Coolief Cooled Radiofrequency Kit, Halyard Health, Alpharetta, Georgia) with 2 mm gap between the electrode tip and the base of the superior articular process. Motor testing (2.0 V, 2 Hz) performed at each target site. Administered 1 ml of 2% lidocaine through the introducer needle, followed by cooled radiofrequency ablation lesioning for 165 seconds at each site, generator temperature set to 60°C (intralesional temperature >80°C). Administered 0.5 ml 0.5% bupivacaine following procedure
Conventional radiofrequency denervation	20-gauge traditional radiofrequency ablation probes with 10 mm active tips (Baylis Medical, Montreal, Canada) placed at medial branch nerve targets using parallel technique. Motor testing and local anesthetic as described for cooled radiofrequency. Radiofrequency lesioning performed for 90 seconds at 80°C at each target site.

Arm Name

Arm Description

Cooled radiofrequency denervation

17-gauge cooled radiofrequency ablation introducer needle placed at medial branch nerve targets, 18-gauge cooled radiofrequency ablation probe with a 4 mm active tip (Coolief Cooled Radiofrequency Kit, Halyard Health, Alpharetta, Georgia) with 2 mm gap between the electrode tip and the base of the superior articular process. Motor testing (2.0 V, 2 Hz) performed at each target site. Administered 1 ml of 2% lidocaine through the introducer needle, followed by cooled radiofrequency ablation lesioning for 165 seconds at each site, generator temperature set to 60°C (intralesional temperature >80°C). Administered 0.5 ml 0.5% bupivacaine following procedure

Conventional radiofrequency denervation

20-gauge traditional radiofrequency ablation probes with 10 mm active tips (Baylis Medical, Montreal, Canada) placed at medial branch nerve targets using parallel technique. Motor testing and local anesthetic as described for cooled radiofrequency. Radiofrequency lesioning performed for 90 seconds at 80°C at each target site.

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Continuous	Pain	NRS 0 to 10, mean change (SD)	All Participants	6 (months)
Continuous	Function	ODI 0 to 100, mean change (SD)	All Participants	6 (months)

Outcome Details

N/A

Risk of Bias Assessment

1. What kind of study is this?


	RCT

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?


	Yes/Yes

9. Intention-to-Treat (ITT) analysis?

10. Avoidance of selective outcomes reporting

11. Quality rating

Results

Continuous

Pain (NRS 0 to 10, mean change (SD))

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Cooled radiofrequency denervation	Conventional radiofrequency denervation
6 (months)
	Mean			Mean Difference (MD)
	SD			95% CI low (MD)
				95% CI high (MD)
				SD (MD)
				p value (MD)
		Within Arm Comparisons			Net Comparisons
		Cooled radiofrequency denervation	Conventional radiofrequency denervation

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

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Cooled radiofrequency denervation	Conventional radiofrequency denervation
6 (months)
	Mean			Mean Difference (MD)
	SD			95% CI low (MD)
				95% CI high (MD)
				SD (MD)
				p value (MD)
		Within Arm Comparisons			Net Comparisons
		Cooled radiofrequency denervation	Conventional radiofrequency denervation

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Extraction form for project: Interventional Treatments for Acute and Chronic Pain: Systematic Review