Abstract
Study design
Descriptive case series.
Objective
The aim of the study is to investigate the pain associated with magnetically controlled growing rod (MCGR) lengthening procedures.
Summary of background data
MCGRs have gained popularity because they offer non-surgical lengthening procedures in early-onset scoliosis (EOS) instead of semi-annual open surgery elongations with traditional growing rods. Many aspects of MCGR treatment have been investigated, but pain in conjunction with distraction is only sparsely described in the literature.
Methods
Pain intensity was assessed in 25 EOS patients before, during and after MCGR lengthening procedures in an outpatient setup. They underwent at least two (range 2–16) lengthening procedures prior to this study. The pain intensity was estimated using patient-reported Faces Pain Scale (FPS-R), caregiver-reported pain numeric rating scale (NRS), and NRS and revised Face, Legs, Activity, Cry, Consolability scale (r-FLACC) by two medically trained observers. The inter-rater reliability and correlation between instruments were analyzed.
Results
23 of 25 EOS patients (8- to 16-year old) with mixed etiology were able to self-report pain. The average pain intensity was mild: median 1 (range 0–6) on all four instruments on a 0-to-10 scale. Afterward, 22/25 patients (88%) were completely pain free and the remaining 3 patients had a pain score of 1. MCGR stalling (i.e. clunking) was encountered in 14/25 (56%) of the patients without impact on the pain intensity.
Conclusions
The average maximum pain intensities during the lengthening procedures were mild and pain ceased within few minutes. The inter-rater reliability was good to excellent for NRS and r-FLACC, and there were high correlations between all the four pain instruments, indicating high criterion validity.
Level of evidence
Level IV, case series.
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Acknowledgements
We express our appreciation to the patients and their parents for participating, and to Ebbe Stender Hansen, Kristian Høy, Kestutis Valancius and Peter Helmig for their contribution in the treatment of the patients.
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No external funding was received for the study.
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STS, CB, HL, JDR: Conception and design, STS, HL, MVL: Acquisition, STS, JDR: Analysis, STS, CB, JDR: Interpretation of data, STS, JDR: Drafting of the manuscript, STS, CB, HL, MVL, JDR: Critical revision of the manuscript for important intellectual content, STS, CB, HL, MVL, JDR: Final approval.
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Professor Cody Bünger holds patents for early-onset scoliosis treatment but not in relation to the CB concept or the magnetic-controlled growing rods. The remaining authors certify that they have no financial conflicts of interest in relation to this study.
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The local regional Committee on Biomedical Research Ethics (Ref. 126/2014) and the Danish Data Protection Agency (1-16-02-92-14).
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The revised Faces Pain Scale is reproduced with permission from IASP, www.iasp-pain.org/fpsr, and may NOT be reproduced for any other purpose without permission.
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Skov, S.T., Bünger, C., Li, H. et al. Lengthening of magnetically controlled growing rods caused minimal pain in 25 children: pain assessment with FPS-R, NRS, and r-FLACC. Spine Deform 8, 763–770 (2020). https://doi.org/10.1007/s43390-020-00096-3
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DOI: https://doi.org/10.1007/s43390-020-00096-3