Wang 2016

Methods	Design: two‐arm single‐centre parallel‐group randomised controlled trial Setting: China Timing: January 2009 to January 2013 Interventions: percutaneous vertebroplasty or facet joint injection with steroid and local anaesthetic Sample size:a priori sample size calculation not reported Analysis: intention‐to‐treat analysis
Participants	Number of participants 384 screened for eligibility 167 excluded (71 did not meet inclusion criteria, 42 declined to participate, 54 requested vertebroplasty) 217 patients were randomised (108 to vertebroplasty and 109 to facet joint injection) Data were available for 100 (92%) in vertebroplasty group and 106 (97%) in facet joint injection at 12‐month follow‐up Inclusion criteria Severe pain caused by acute (fracture occurred within 2 weeks) or subacute (fracture occurred within 2–8 weeks) osteoporotic vertebral fracture. Exclusion criteria Age < 55 years Posterior margin body or spinal cord damage Long‐term use of anti‐coagulant drugs Senile dementia Cognitive damage or other cerebral disease Malignant disease Spinal infection or skin disease Metabolic bone disease Tubular bone fractures Allergy to radiopaque agents Baseline characteristics Percutaneous vertebroplasty Mean (SD) age (years): 63.7 (5.7) No. male/female: 19/81 No. acute fractures: 87 No. Subacute fractures: 13 Mean (SD) Bone density T score: ‐3.06 (0.38) No. (%) use of osteoporotic drugs: 23 (23) No. (%) new fracture patients: 13 (13) Facet joint injection Mean (SD) age (years): 62.9 (5.3) No. male/female: 22/84 No. acute fractures: 90 No. Subacute fractures: 16 Mean (SD) Bone density T score: ‐3.03 (0.41) No. (%) use of osteoporotic drugs: 19 (18) No. (%) new fracture patients: 11 (10.4)
Interventions	Both vertebroplasty and facet joint injection were performed under local anaesthesia using a plane angiography system under fluoroscopic guidance by spine surgeons in the hospital. Postural reduction was performed before surgery. Percutaneous vertebroplasty Vertebroplasty was performed using a bilateral or unilateral transpedicular approach. The patient was placed in the prone position on the table. After positioning of the fractured vertebrae and administration of local anaesthesia, an incision (approximately 5 mm long) was made using a scalpel. A bone puncture needle was then placed in the fractured vertebral body, transpedicularly. After removal of the inner needle, 3 mL to 9 mL of a poly methyl methacrylate (PMMA) bone cement was injected into the fractured vertebrae under continuous fluoroscopic visualization via lateral and antero‐posterior projections in order to ensure adequate filling and to avoid cement extravasation posteriorly into the spinal canal or migration into the venous system to prevent pulmonary embolism, which is a significant complication. The injection was stopped when the surgeon met substantial resistance or when the cement reached the cortical edge of the fractured vertebral body; the injection was also stopped if cement was near the spinal canal or leaked into extraosseous structures. Facet joint injection Injection was performed using a bilateral posterior approach with the participant in the prone position. After positioning of the fractured vertebral body and administration of local anaesthesia, a spinal needle was inserted into the facet joint capsule of the fractured vertebral body. Thereafter, a mixture of prednisolone (125 mg:5 mL) and lidocaine (100 mg:5 mL) was injected under fluoroscopic monitoring. Follow‐up care Participants in both groups wore a brace for 3 months after treatment.
Outcomes	Outcomes were reported at 1 day, 1 week, 1, 3, 6, and 12 months after treatment A primary outcome was not specified. Outcomes reported VAS scale measuring pain relief (scores range from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable Oswestry Disability Index (ODI) Roland‐Morris Disability Questionnaire (RMDQ) SF‐36 (measured only at 1, 3, 6 and 12 months) Incident radiographic vertebral fractures detected on antero‐posterior and lateral spinal radiograph examinations (3, 6, and 12 months) Mean operation time Postoperative hospitalisation time Outcomes included in this review Pain (VAS) Disability (RMDQ) Quality of life (SF‐36 MCS) Incident radiographic vertebral fractures
Source of funding	The authors reported that no funds were received in support of this study.
Notes	Clinicaltrials.gov trial identifier, or other trial registration record: none found. Protocol publication not found.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation schedule.
Allocation concealment (selection bias)	Low risk	Not clearly reported, but as allocation was performed by an independent observer, bias may have been minimised.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not reported, appears unblinded.
Blinding of outcome assessment (detection bias) Self‐reported outcomes (e.g., pain, disability)	High risk	The article did not report blinding of participants. The primary and secondary outcomes were self‐reported questionnaires, hence there is risk of bias in measurement of pain, physical functioning and quality of life.
Blinding of outcome assessment (detection bias) Objective outcomes (e.g., radiographic outcomes)	High risk	Outcome assessors were unblinded thus there is a risk of bias in the assessment of incident radiographic vertebral fractures.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	8/108 (7.4%) in the vertebroplasty group and 3/109 (2.7%) in the facet joint injection group were lost to follow‐up.
Selective reporting (reporting bias)	Unclear risk	The results of all study outcomes were reported. Study protocol was not found.
Other bias	Low risk	No other biases apparent.