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Vertebroplasty for acute painful osteoporotic fractures (VAPOUR): study protocol for a randomized controlled trial.

ABSTRACT: With increasing human longevity there is increasing prevalence of osteoporosis and of osteoporotic vertebral fractures. Most vertebral fractures do not require medical therapy for pain, but a minority are associated with severe pain and disability. Vertebroplasty has been used increasingly for painful acute osteoporotic fractures. The best available evidence for vertebroplasty is provided by two placebo controlled trials which showed no significant clinical benefit of vertebroplasty over placebo. These were not acute fracture trials with the majority of fractures in both trials being well beyond the acute time frame of 6 weeks. There is evidence from an open label randomized controlled trial of vertebroplasty versus conservative therapy in acute fractures suggesting clinical efficacy in acute vertebral fractures.This is a blinded trial of Vertebroplasty for Acute Painful Osteoporotic fractURes - the VAPOUR trial. Patients greater than 60 years in age with new severe onset of back pain and osteoporotic vertebral fractures of less than 6 weeks duration will be enrolled. They will be randomized to receive either vertebroplasty or a placebo procedure. Data regarding pain, disability, and quality of life will be collected over a 6-month period. The enrolled patients and the outcome assessors will remain blinded for the duration of the trial.The VAPOUR trial will apply similar methodology to the previous blinded trials but in a patient group with exclusively acute fractures and the most severe pain.ClinicalTrials.gov trial identifier: NCT01482793 registered on 28 November 2011.

SUBMITTER: Clark W

PROVIDER: S-EPMC4399105 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Vertebroplasty for acute painful osteoporotic fractures (VAPOUR): study protocol for a randomized controlled trial.

Clark William W Bird Paul P Diamond Terrence T Gonski Peter P

Trials 20150412

<h4>Background</h4>With increasing human longevity there is increasing prevalence of osteoporosis and of osteoporotic vertebral fractures. Most vertebral fractures do not require medical therapy for pain, but a minority are associated with severe pain and disability. Vertebroplasty has been used increasingly for painful acute osteoporotic fractures. The best available evidence for vertebroplasty is provided by two placebo controlled trials which showed no significant clinical benefit of vertebro ...[more]

PMID: 25873274

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Project description:OBJECTIVE:To assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body. DESIGN:Randomised, double blind, sham controlled clinical trial. SETTING:Four community hospitals in the Netherlands, 2011-15. PARTICIPANTS:180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89). INTERVENTIONS:Participants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group. MAIN OUTCOME MEASURES:Main outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months' follow-up. RESULTS:The mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval -0.53 to 0.94) at baseline, -0.43 (-1.17 to 0.31) at one day, -0.11 (-0.85 to 0.63) at one week, 0.41 (-0.33 to 1.15) at one month, 0.21 (-0.54 to 0.96) at three months, 0.39 (-0.37 to 1.15) at six months, and 0.45 (-0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months' follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction. CONCLUSIONS:Percutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months' follow-up among patients with acute osteoporotic vertebral compression fractures. TRIAL REGISTRATION:ClinicalTrials.gov NCT01200277.

Project description:IntroductionMultiple myeloma (MM) is a plasma cell cancer where about 1/3 of the patients present with pathological fractures at the time of diagnosis. Despite treatment, the majority of the patients will develop additional fractures. Because survival and prognosis has improved significantly over the last two decades for patients with MM, there is an increased need to focus on optimal fracture treatment. Traditionally, fracture pain is treated conservatively with opioids, bisphosphonates, bracing and radiation therapy. Vertebral augmentation has been used for the last three decades as a minimally invasive treatment option for vertebral compression fractures, but the evidence base for the efficacy is weak. We describe a trial assessing the impact of vertebroplasty on clinical outcome in the treatment of patients with MM with painful vertebral fractures.Methods100 patients with MM with painful vertebral fractures will be randomised in a prospective, single-blinded, multicentre, clinical trial where patients are randomised to either usual care or usual care supplemented with vertebroplasty with a possibility of crossover 4 weeks after randomisation. The primary outcome will be change in Oswestry Disability Index at 4 weeks.AnalysisPrimary and secondary outcomes are assessed at baseline and at 4, 8, 26 and 52 weeks. Categorical data will be presented by means of frequencies and related percentages; continuous data will be displayed by means of descriptive statistics.Ethics and disseminationThe study has been evaluated by the Regional Committees on Health Research for Southern Denmark (S-20200075) and notified and approved by the Region of Southern Denmark and listed in the internal record, journal no. 20/22355. All participants provide consent. The protocol will follow the SPIRIT (Standard Protocol Items for Randomized Trials) statement. The Danish Myeloma Patient Organization supports the study. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences.Trial registration numberNCT04533217.

Dataset Information

Vertebroplasty for acute painful osteoporotic fractures (VAPOUR): study protocol for a randomized controlled trial.

Publications

Vertebroplasty for acute painful osteoporotic fractures (VAPOUR): study protocol for a randomized controlled trial.

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