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


	VERTOS IV

3. Setting

Country


	the Netherlands

4. Study Design


	RCT

5. Mean Age (Years)

Input the mean age for the entire sample


	75.8

6. Percent Female

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


	75

7. Number Randomized


	180

8. Pain Duration Measure (Mean, Median)


	Mean Median ND

9. Pain Duration (Weeks)


	6 vs. 5

10. Duration of Followup (Months)


	12

Arms

Arm Name	Arm Description
Vertebroplasty	Bone biopsy needles at vertebral body positioned bilaterally, using standard transpedicular placements with local anesthetic (1% lidocaine into each pedicle followed by 0.25% ropivacaine) unless conscious sedation required (50 μg fentanyl in 22% of patients), PMMA injection stopped when cement leakage was noticed via CT (mean PMMA volume 5.1 ml [SD 1.8]). In participants with multiple fractures, all were treated.
Sham vertebroplasty	Stab incisions at level of the vertebral body, local anesthetic as above, PMMA prepared in close proximity to the participants to duplicate mixing sound and smell; simulated procedure using verbal and physical cues.

Arm Name

Arm Description

Vertebroplasty

Bone biopsy needles at vertebral body positioned bilaterally, using standard transpedicular placements with local anesthetic (1% lidocaine into each pedicle followed by 0.25% ropivacaine) unless conscious sedation required (50 μg fentanyl in 22% of patients), PMMA injection stopped when cement leakage was noticed via CT (mean PMMA volume 5.1 ml [SD 1.8]). In participants with multiple fractures, all were treated.

Sham vertebroplasty

Stab incisions at level of the vertebral body, local anesthetic as above, PMMA prepared in close proximity to the participants to duplicate mixing sound and smell; simulated procedure using verbal and physical cues.

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Continuous	Pain	Pain intensity (mean [SD], 0 to 10 VAS)	All Participants	1 (week) 1 (month) 3 (months) 6 (months) 1 (year) 1 (Day)
Categorical	Harms	Mortality	All Participants	1 (year)
Categorical	Harms	Incident vertebral compression fracture	All Participants	1 (year)

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

Categorical

Harms (Mortality)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Vertebroplasty	Sham vertebroplasty
1 (year)
	Events			Odds Ratio (OR)
	Percentage			95% CI low (OR)
				95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Vertebroplasty	Sham vertebroplasty

Harms (Incident vertebral compression fracture)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Vertebroplasty	Sham vertebroplasty
1 (year)
	Events			Odds Ratio (OR)
	Percentage			95% CI low (OR)
				95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Vertebroplasty	Sham vertebroplasty

Continuous

Pain (Pain intensity (mean [SD], 0 to 10 VAS))

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Vertebroplasty	Sham vertebroplasty
1 (week)
	Mean			Mean Difference (MD)
	SD			95% CI low (MD)
				95% CI high (MD)
				SD (MD)
				p value (MD)
1 (month)
	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)
1 (year)
	Mean			Mean Difference (MD)
	SD			95% CI low (MD)
				95% CI high (MD)
				SD (MD)
				p value (MD)
1 (Day)
	Mean			Mean Difference (MD)
	SD			95% CI low (MD)
				95% CI high (MD)
				SD (MD)
				p value (MD)
		Within Arm Comparisons			Net Comparisons
		Vertebroplasty	Sham vertebroplasty

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