Blasco 2012.

Methods	Design: single‐centre parallel group, two‐arm open‐label randomised controlled trial Setting: patients recruited from primary care centres, Spain Timing: April 2006 to Jan 2010 Intervention: percutaneous vertebroplasty and usual care versus usual care alone Sample size: 64 patients required per group to have 80% power to detect a difference of at least 1.5 units on a 0‐10 VAS between groups in primary pain endpoint; overall type‐1 error rate was set at 5% Analysis: intention‐to‐treat analysis
Participants	Number of participants 219 patients screened for eligibility 94 excluded (55 did not meet inclusion criteria, 14 declined participation and 25 had other reasons) 125 randomised (64 to vertebroplasty and 61 to usual care) Data for 110 (54 (84%) for vertebroplasty and 56 (92%) for usual care) available at the 2‐month follow‐up Data for 95 (47 (73%) for vertebroplasty and 48 (79% for usual care) available at the final 12‐month follow‐up Inclusion criteria Acute, painful osteoporotic vertebral fracture from T4 to L5 with clinical onset < 12 months confirmed by spine radiograph and oedema present on MRI or positive bone scan if MRI contraindicated Pain at least 4 on a 0‐10 VAS where higher scores indicated worse pain Exclusion criteria Untreatable coagulopathy Active local or systemic infection Current malignancy Vertebral canal occupation by a fragment of the vertebral body Non‐osteoporotic vertebral fracture Active associated disorders such as fibromyalgia or spondyloarthropathies Other disorders (such as dementia) that affect quality of life or pain assessment Baseline characteristics Vertebroplasty group (64 participants): Mean (SD) age: 71.33 (9.95); 47 female, 17 male Mean (SD) duration of back pain: 140.3 (96.09) days Number (%) participants with symptom onset < 6 weeks: 2 (3%) Number (%) participants with symptom onset < 4 months: 32 (50%) Mean (SD) number of vertebral fractures at baseline: 3.55 (2.82) Mean (SD) baseline pain score 7.21 (0.33) on a 0‐10 VAS (higher score indicates worse pain) Mean (SD) QUALEFFO‐41 score: 65.19 (2.23) on a 0 to 100 scale (higher score indicates worse quality of life) Usual care group (61 participants): Mean (SD) age: 75.27 (8.53); 50 female, 11 male Mean (SD) duration of back pain: 143.1 (130.33) days Number (%) participants with symptom onset < 6 weeks: 4 (7%) Number (%) participants with symptom onset < 4 months: 32 (52.5%) Mean (SD) number of vertebral fractures at baseline: 3.02 (2.14) Mean (SD) baseline pain score: 6.31 (0.35) Mean (SD) QUALEFFO‐41 score: 59.17 (2.17)
Interventions	Vertebroplasty group Percutaneous vertebroplasty was performed by an experienced interventional neuroradiologist. A 25‐gauge needle was used to infiltrate the skin overlying the pedicle and to infiltrate the periosteum of the posterior lamina. Using a bilateral transpedicular approach a 10‐ or 13‐gauge needle was inserted posterolaterally relative to the eye of the pedicle, and through gentle tapping the needle penetrated the pedicle into the anterior two‐thirds of the fractured vertebrae and polymethylmethacrylate cement was injected. Following the procedure, participants were strictly rested in bed for 6 hours. Standardised analgesics were given as necessary and nasal calcitonin was given for the first month. Usual care group All participants received analgesics with a standardised format and nasal calcitonin for the first month. In case of no improvement in pain, the participant was considered for vertebroplasty (timing of decision not specified). Both groups When treatment in either group was ineffective (defined as pain 7 or more out of 10) or there was an intolerance to drug therapy, participants were offered rescue therapy consisting of an intrathecal infusion of 25 μg fentanyl and 1.5 mg bupivacaine. After one month, both treatment groups began or continued treatment with bisphosphonates (or teriparatide or strontium ranelate if there was an intolerance to bisphosphonates), prescribed by the attending physician.
Outcomes	Participants were assessed at baseline, 2 weeks, and at 2, 6 and 12 months. Outcomes Pain measured on a 0 to 10 VAS (0 indicates no pain and 10 is maximum pain) Number of participants with moderate (pain ≥ 4) or severe (pain ≥ 7) pain at 12 months Quality of life questionnaire of the European Foundation for Osteoporosis (QUALEFFO‐41), scores range from 0 to 100, with lower scores indicating a better quality of life Analgesic consumption (nil, minor analgesics and/or NSAIDs, minor opioid derivatives, major opioid derivatives) Radiologically apparent incident vertebral fractures measured at 6 and 12 months, defined as a reduction of 20% or more in the anterior, middle or posterior height of the vertebral body compared with adjacent undeformed vertebrae Clinically apparent incident vertebral fractures confirmed on MRI at any time during follow‐up Bone densitometry (dual X‐ray absorptiometry [DXA] measured at baseline and 12 months Number of participants who received rescue therapy (intrathecal infusion with 25 μg and 1.5 mg bupivacaine) Height Weight (not reported in the paper) Cement leakage during procedure Development of chronic back pain Outcomes included in this review Pain QUALEFFO Incident vertebral fractures
Source of funding	Fundacio La Marato de TV3, the Spanish Society of Medical Radiology and the Catalan Society of Rheumatology
Notes	Trial registered on 13 Oct 2009 at ClinicalTrials.gov, registration number NCT00994032. We extracted pain and quality of life data at 2 weeks, 2 months (pooled with the 3‐month outcome data from other trials), 6 and 12 months. These outcomes were reported in graphical format only; we extracted the mean and 95% confidence intervals from the graphs (http://plotdigitizer.sourceforge.net/) and converted 95% CI to SD. Adverse events were only reported for vertebroplasty. It is not reported if any adverse events occurred with usual care.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Performed using a computer‐generated random list.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Neither participants nor personnel were blinded.
Blinding of outcome assessment (detection bias) Self‐reported outcomes (e.g., pain, disability)	High risk	Participants assessed their pain and quality of life and were not blinded.
Blinding of outcome assessment (detection bias) Objective outcomes (e.g., radiographic outcomes)	High risk	Rheumatologists who assessed radiographs and MRIs were not blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The proportion lost to follow‐up was similar between groups at the 12‐month follow‐up (17/64 or 27% from vertebroplasty and 13/61 or 21% from usual care), although the authors report that the losses may not have been random, but related to worse pain in the usual care group.
Selective reporting (reporting bias)	Unclear risk	Adverse events reported for vertebroplasty group; it is unclear if any adverse events occurred in the usual care group; mean pain and quality of life and confidence intervals were reported graphically only.
Other bias	Low risk	None apparent.