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. 2025 Nov 4;15(11):e105053.
doi: 10.1136/bmjopen-2025-105053.

Prevention of postamputation pain with targeted muscle reinnervation (PreventPAP trial): protocol for a national, multicentre, randomised, sham-controlled trial

Guus A H Tendijck  1   2 , Jan van Schaik  2 , Robert R Dijkman  3 , Marieke Niesters  4 , Erik W van Zwet  5 , Wilbert B van den Hout  5 , Arianne J Ploeg  6 , Willem G van Rijt  7 , Godard C W de Ruiter  8 , J Henk Coert  9 , Liron S Duraku  10 , J Michiel Zuidam  11 , Willemien van de Water  12 , Willem Pondaag  13   14 , Hanneke van der Krogt  15 , Justus L Groen  13   14 ; PreventPAP consortium
Collaborators, Affiliations

Prevention of postamputation pain with targeted muscle reinnervation (PreventPAP trial): protocol for a national, multicentre, randomised, sham-controlled trial

Guus A H Tendijck et al. BMJ Open. .

Abstract

Introduction: In the Netherlands, approximately 2200 major amputations of the lower extremities are performed each year, the majority in vascular patients. Around 61% of these patients will develop postamputation pain (PAP). PAP is a severe, lifelong, disabling condition profoundly affecting quality of life. During amputations, the common practice is to cut the nerves without employing nerve-surgical techniques to prevent chronic pain due to neuroma formation. In recent years, targeted muscle reinnervation (TMR) has been the most frequently studied technique for treating PAP, inhibiting neuroma formation by rerouting the cut mixed nerve to a functional motor nerve. We hypothesise that a primary TMR procedure during major lower limb amputations will result in a lower prevalence of PAP.

Methods and analysis: We propose a national, multicentre, randomised, sham-controlled trial comparing TMR with traction neurectomy in major amputations of the lower extremities in patients with vascular disease. 203 patients will be recruited with an indication for a transfemoral to transtibial amputation as a primary or secondary sequela of vascular disease. The subjects are randomly assigned to the TMR group or the traction neurectomy group. PAP will be evaluated 1 year postoperatively as the primary endpoint. Secondary outcomes include quality of life, mobility, neuropathic pain, hospital anxiety and depression, cost-effectiveness and complications.

Ethics and dissemination: This study has been reviewed and approved by the local ethical review body, 'The Medical Ethics Committee Leiden The Hague Delft', under the reference: P24.073 on 28 November 2024. Results will be published in peer-reviewed journals.

Trial registration number: NCT06719245. Dutch trial registry: NL87196.058.24.

Keywords: Amputation, Surgical; Clinical Protocols; NEUROSURGERY; PAIN MANAGEMENT; Randomized Controlled Trial; Vascular surgery.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1. Nerve coaptation calibre mismatch score. Outer circle: amputated nerve; inner circle: motor nerve.
Figure 2
Figure 2. Consolidated Standards of Reporting Trials (CONSORT) flow diagram of predicted patient inclusion.
See this image and copyright information in PMC

References

    1. Frölke JPM, Rommers GMC, de Boer AW, et al. Epidemiology of Limb Amputations and Prosthetic Use During COVID-19 Pandemic in the Netherlands. Arch Phys Med Rehabil. 2024;105:280–6. doi: 10.1016/j.apmr.2023.07.012. - DOI - PubMed
    1. Ziegler-Graham K, MacKenzie EJ, Ephraim PL, et al. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008;89:422–9. doi: 10.1016/j.apmr.2007.11.005. - DOI - PubMed
    1. Schwingler PM, Moman RN, Hunt C, et al. Prevalence of postamputation pain and its subtypes: a meta-analysis with meta-regression. Pain Rep. 2021;6:e918. doi: 10.1097/PR9.0000000000000918. - DOI - PMC - PubMed
    1. Nederlandse Vereniging van Revalidatieartsen Amputatie en prothesiologie onderste extremiteit. 2020. https://richtlijnendatabase.nl/richtlijn/amputatie_prothesiologie_onders... Available.
    1. Torrance N, Lawson KD, Afolabi E, et al. Estimating the burden of disease in chronic pain with and without neuropathic characteristics: does the choice between the EQ-5D and SF-6D matter? Pain. 2014;155:1996–2004. doi: 10.1016/j.pain.2014.07.001. - DOI - PMC - PubMed

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