Dataset Information

Vertebroplasty in patients with multiple myeloma with vertebral compression fractures: protocol for a single-blind randomised controlled trial.

ABSTRACT:

Introduction

Multiple 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.

Methods

100 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.

Analysis

Primary 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 dissemination

The 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 number

NCT04533217.

SUBMITTER: Wickstroem LA

PROVIDER: S-EPMC8422322 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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.

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