TY - JOUR
T1 - Electrical stimulation to prevent recurring pressure ulcers in individuals with a spinal cord injury compared to usual care
T2 - the Spinal Cord Injury PREssure VOLTage (SCI PREVOLT) study protocol
AU - Wijker, Boas J.
AU - de Groot, Sonja
AU - van Dongen, Johanna M.
AU - van Nassau, Femke
AU - Adriaansen, Jacinthe J. E.
AU - Achterberg-Warmer, Wendy J.
AU - Anema, Johan R.
AU - Riedstra, Andries T.
AU - van Tulder, Maurits W.
AU - Janssen, Thomas W. J.
N1 - Funding Information: The authors would like to like to thank the following members and involved researchers of the SCI-PREVOLT project group: Ludwine van Orsouw PA, Suzanne Romviel MSc, Guido van Werven MSc, Ralph Scholten?PT, Anne Marie Ter Steeg?MD, Amber Wighman MSc. TJ conceived the study in collaboration with WA, JA, SG, AR, AS, FvN, JAn and MvT. BW, TJ, MvT, JD, SG and FvN have made the largest contributions to setting up the protocol in collaboration with JA, WA and AW. BW, TJ, MvT, JD, SG and FvN will all play an important role in the processing of the data and the performance of the statistical analysis. All authors approved the drafts before the submission of the article. SCI-PREVOLT is sponsored by ZonMw (the Netherlands Organisation for Health Research and Development Project), Project number 853001111. The ultrasound and the pressure distribution mat are Funded by the Reade Foundation. After study publication, the data will be kept for a maximum of 1 year with the research group. After this year, the research group intend to make the data accessible for further research in the same line as this study (same kind of goals, aims and purposes. However, access to the data set will be limited and access can only be allowed under certain conditions and with the approval of the original research team. Funding Information: SCI-PREVOLT is sponsored by ZonMw (the Netherlands Organisation for Health Research and Development Project), Project number 853001111. The ultrasound and the pressure distribution mat are Funded by the Reade Foundation. Publisher Copyright: © 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - BACKGROUND: Pressure ulcers (PUs) on the buttocks are among the most common secondary complications in individuals with chronic spinal cord injury (SCI). PUs can result from sitting for extended periods, disuse atrophy, increased sitting pressure and reduced circulation. Compared with usual care, activation of paralysed muscles using electrical stimulation (ES) has been shown to markedly increase paralysed muscle mass, improve circulation of skin and muscle and improve sitting pressure distribution. ES might therefore be a useful method to reduce PU incidence. METHODS: A multicentre randomized controlled trial (SCI PREVOLT) will be conducted with an economic and process evaluation alongside. One hundred participants with a SCI in the chronic phase and a minimal incidence of 1 PU in the last 5 years will be recruited from rehabilitation centres across the Netherlands. Participants will be stratified by centre and age and randomized to the intervention or control group. The intervention group will use ES at least 1 h/day during at least 4 times a week for 1 year next to usual care. The control group will only receive usual care. The primary outcome is the incidence of PUs, measured by a blinded person assessing the presence or absence of a PU on the buttocks on a photo made by the participant or his/her caregiver. The incidence of a PU will be evaluated every 2 weeks. Secondary outcomes include interface pressure distribution, blood flow in the profunda femoris artery, muscle thickness of the hamstrings and gluteal muscles and questionnaires about different dimensions of life, e.g. participation and quality of life. Secondary outcomes will be measured at baseline and 3, 6, 9 and 12 months after randomization. DISCUSSION: This study will assess if electrical stimulation is a (cost-)effective method to prevent PUs and reduce the risk factors of getting PUs. If ES is effective and cost-effective compared with usual care, ES could be implemented in daily treatment of individuals with a SCI. TRIAL REGISTRATION: Netherlands Trials Register NTR NL9469 . Registered on 26 May 2021.
AB - BACKGROUND: Pressure ulcers (PUs) on the buttocks are among the most common secondary complications in individuals with chronic spinal cord injury (SCI). PUs can result from sitting for extended periods, disuse atrophy, increased sitting pressure and reduced circulation. Compared with usual care, activation of paralysed muscles using electrical stimulation (ES) has been shown to markedly increase paralysed muscle mass, improve circulation of skin and muscle and improve sitting pressure distribution. ES might therefore be a useful method to reduce PU incidence. METHODS: A multicentre randomized controlled trial (SCI PREVOLT) will be conducted with an economic and process evaluation alongside. One hundred participants with a SCI in the chronic phase and a minimal incidence of 1 PU in the last 5 years will be recruited from rehabilitation centres across the Netherlands. Participants will be stratified by centre and age and randomized to the intervention or control group. The intervention group will use ES at least 1 h/day during at least 4 times a week for 1 year next to usual care. The control group will only receive usual care. The primary outcome is the incidence of PUs, measured by a blinded person assessing the presence or absence of a PU on the buttocks on a photo made by the participant or his/her caregiver. The incidence of a PU will be evaluated every 2 weeks. Secondary outcomes include interface pressure distribution, blood flow in the profunda femoris artery, muscle thickness of the hamstrings and gluteal muscles and questionnaires about different dimensions of life, e.g. participation and quality of life. Secondary outcomes will be measured at baseline and 3, 6, 9 and 12 months after randomization. DISCUSSION: This study will assess if electrical stimulation is a (cost-)effective method to prevent PUs and reduce the risk factors of getting PUs. If ES is effective and cost-effective compared with usual care, ES could be implemented in daily treatment of individuals with a SCI. TRIAL REGISTRATION: Netherlands Trials Register NTR NL9469 . Registered on 26 May 2021.
KW - Cost-benefit analysis
KW - Electrical stimulation
KW - Pressure ulcer
KW - Prevention and control
KW - Process evaluation
KW - Randomized controlled trial
KW - Secondary prevention
KW - Spinal cord injuries
UR - http://www.scopus.com/inward/record.url?scp=85124774758&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-022-06088-0
DO - https://doi.org/10.1186/s13063-022-06088-0
M3 - Article
C2 - 35172888
SN - 1745-6215
VL - 23
SP - 156
JO - Trials
JF - Trials
IS - 1
M1 - 156
ER -