Cargando…

Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial

BACKGROUND: About 69% of Americans living with spinal cord injury (SCI) suffer from long-term debilitating neuropathic pain, interfering with the quality of daily life. Neuropathic pain is refractory to many available treatments—some carrying a risk for opioid addiction—highlighting an urgent need f...

Descripción completa

Detalles Bibliográficos
Autores principales: Van de Winckel, Ann, Carpentier, Sydney, Deng, Wei, Zhang, Lin, Battaglino, Ricardo, Morse, Leslie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10464017/
https://www.ncbi.nlm.nih.gov/pubmed/37608389
http://dx.doi.org/10.1186/s40814-023-01374-3
_version_ 1785098369230700544
author Van de Winckel, Ann
Carpentier, Sydney
Deng, Wei
Zhang, Lin
Battaglino, Ricardo
Morse, Leslie
author_facet Van de Winckel, Ann
Carpentier, Sydney
Deng, Wei
Zhang, Lin
Battaglino, Ricardo
Morse, Leslie
author_sort Van de Winckel, Ann
collection PubMed
description BACKGROUND: About 69% of Americans living with spinal cord injury (SCI) suffer from long-term debilitating neuropathic pain, interfering with the quality of daily life. Neuropathic pain is refractory to many available treatments—some carrying a risk for opioid addiction—highlighting an urgent need for new treatments. In this study, we will test our hypothesis that Spring Forest Qigong™ will reduce SCI-related neuropathic pain by improving body awareness. We will determine whether remotely delivered Qigong is feasible and we will collect data on neuropathic pain, and other reported associations with pain such as spasms frequency and/or severity, functional performance, mood, and body awareness. METHODS: In this quasi-experimental pilot clinical trial study, adults with SCI will practice Qigong at home with a 45-min video, at least 3 × /week for 12 weeks. The Qigong practice includes movements with guided breathing and is individualized based on functional abilities, i.e., the participants follow along with the Qigong movements to the level of their ability, with guided breathing, and perform kinesthetic imagery by focusing on the feeling in the whole body as if doing the whole-body Qigong movement while standing. The highest, average, and lowest neuropathic pain ratings perceived in the prior week will be recorded weekly until the 6-week follow-up. The other outcomes will be collected at 5 time points: at baseline, midway during the Qigong intervention (6 weeks), after the Qigong intervention (12 weeks), after a 6-week and 1-year follow-up. Rate parameters for the feasibility markers will be estimated based on the participants who achieved each benchmark. DISCUSSION: The University of Minnesota (UMN)’s Institutional Review Board (IRB) approved the study (IRB #STUDY00011997). All participants will sign electronic informed consent on the secure UMN REDCap platform. The results will be presented at academic conferences and published in peer-reviewed publications. TRIAL REGISTRATION: ClinicalTrial.gov registration number: NCT04917107, (this protocol paper refers to the substudy), first registered 6/8/2021.
format Online
Article
Text
id pubmed-10464017
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-104640172023-08-30 Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial Van de Winckel, Ann Carpentier, Sydney Deng, Wei Zhang, Lin Battaglino, Ricardo Morse, Leslie Pilot Feasibility Stud Study Protocol BACKGROUND: About 69% of Americans living with spinal cord injury (SCI) suffer from long-term debilitating neuropathic pain, interfering with the quality of daily life. Neuropathic pain is refractory to many available treatments—some carrying a risk for opioid addiction—highlighting an urgent need for new treatments. In this study, we will test our hypothesis that Spring Forest Qigong™ will reduce SCI-related neuropathic pain by improving body awareness. We will determine whether remotely delivered Qigong is feasible and we will collect data on neuropathic pain, and other reported associations with pain such as spasms frequency and/or severity, functional performance, mood, and body awareness. METHODS: In this quasi-experimental pilot clinical trial study, adults with SCI will practice Qigong at home with a 45-min video, at least 3 × /week for 12 weeks. The Qigong practice includes movements with guided breathing and is individualized based on functional abilities, i.e., the participants follow along with the Qigong movements to the level of their ability, with guided breathing, and perform kinesthetic imagery by focusing on the feeling in the whole body as if doing the whole-body Qigong movement while standing. The highest, average, and lowest neuropathic pain ratings perceived in the prior week will be recorded weekly until the 6-week follow-up. The other outcomes will be collected at 5 time points: at baseline, midway during the Qigong intervention (6 weeks), after the Qigong intervention (12 weeks), after a 6-week and 1-year follow-up. Rate parameters for the feasibility markers will be estimated based on the participants who achieved each benchmark. DISCUSSION: The University of Minnesota (UMN)’s Institutional Review Board (IRB) approved the study (IRB #STUDY00011997). All participants will sign electronic informed consent on the secure UMN REDCap platform. The results will be presented at academic conferences and published in peer-reviewed publications. TRIAL REGISTRATION: ClinicalTrial.gov registration number: NCT04917107, (this protocol paper refers to the substudy), first registered 6/8/2021. BioMed Central 2023-08-22 /pmc/articles/PMC10464017/ /pubmed/37608389 http://dx.doi.org/10.1186/s40814-023-01374-3 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Van de Winckel, Ann
Carpentier, Sydney
Deng, Wei
Zhang, Lin
Battaglino, Ricardo
Morse, Leslie
Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial
title Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial
title_full Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial
title_fullStr Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial
title_full_unstemmed Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial
title_short Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial
title_sort using remotely delivered spring forest qigong™ to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10464017/
https://www.ncbi.nlm.nih.gov/pubmed/37608389
http://dx.doi.org/10.1186/s40814-023-01374-3
work_keys_str_mv AT vandewinckelann usingremotelydeliveredspringforestqigongtoreduceneuropathicpaininadultswithspinalcordinjuryprotocolofaquasiexperimentalfeasibilityclinicaltrial
AT carpentiersydney usingremotelydeliveredspringforestqigongtoreduceneuropathicpaininadultswithspinalcordinjuryprotocolofaquasiexperimentalfeasibilityclinicaltrial
AT dengwei usingremotelydeliveredspringforestqigongtoreduceneuropathicpaininadultswithspinalcordinjuryprotocolofaquasiexperimentalfeasibilityclinicaltrial
AT zhanglin usingremotelydeliveredspringforestqigongtoreduceneuropathicpaininadultswithspinalcordinjuryprotocolofaquasiexperimentalfeasibilityclinicaltrial
AT battaglinoricardo usingremotelydeliveredspringforestqigongtoreduceneuropathicpaininadultswithspinalcordinjuryprotocolofaquasiexperimentalfeasibilityclinicaltrial
AT morseleslie usingremotelydeliveredspringforestqigongtoreduceneuropathicpaininadultswithspinalcordinjuryprotocolofaquasiexperimentalfeasibilityclinicaltrial