TY - JOUR
T1 - Physiotherapy with integrated virtual reality for patients with complex chronic low back pain
T2 - protocol for a pragmatic cluster randomized controlled trial (VARIETY study)
AU - Slatman, Syl
AU - Ostelo, Raymond
AU - van Goor, Harry
AU - Staal, J. Bart
AU - Knoop, Jesper
N1 - Publisher Copyright:
© 2023. The Author(s).
PY - 2023/2/20
Y1 - 2023/2/20
N2 - BACKGROUND: Chronic low back pain (CLBP) is the most common chronic pain condition worldwide. Currently, primary care physiotherapy is one of the main treatment options, but effects of this treatment are small. Virtual Reality (VR) could be an adjunct to physiotherapy care, due to its multimodal features. The primary aim of this study is to assess the (cost-)effectiveness of physiotherapy with integrated multimodal VR for patients with complex CLBP, compared to usual primary physiotherapy care. METHODS: A multicenter, two-arm, cluster randomized controlled trial (RCT) including 120 patients with CLBP from 20 physiotherapists will be conducted. Patients in the control group will receive 12 weeks of usual primary physiotherapy care for CLBP. Patients in the experimental group will receive treatment consisting of 12 weeks of physiotherapy with integrated, immersive, multimodal, therapeutic VR. The therapeutic VR consists of the following modules: pain education, activation, relaxation and distraction. The primary outcome measure is physical functioning. Secondary outcome measures include pain intensity, pain-related fears, pain self-efficacy and economic measures. Effectiveness of the experimental intervention compared to the control intervention on primary and secondary outcome measures will be analyzed on an intention-to-treat principle, using linear mixed-model analyses. DISCUSSION: This pragmatic, multicenter cluster randomized controlled trial, will determine the clinical and cost-effectiveness of physiotherapy with integrated, personalized, multimodal, immersive VR in favor of usual physiotherapy care for patients with CLBP. TRIAL REGISTRATION: This study is prospectively registered at ClinicalTrials.gov (identifier: NCT05701891).
AB - BACKGROUND: Chronic low back pain (CLBP) is the most common chronic pain condition worldwide. Currently, primary care physiotherapy is one of the main treatment options, but effects of this treatment are small. Virtual Reality (VR) could be an adjunct to physiotherapy care, due to its multimodal features. The primary aim of this study is to assess the (cost-)effectiveness of physiotherapy with integrated multimodal VR for patients with complex CLBP, compared to usual primary physiotherapy care. METHODS: A multicenter, two-arm, cluster randomized controlled trial (RCT) including 120 patients with CLBP from 20 physiotherapists will be conducted. Patients in the control group will receive 12 weeks of usual primary physiotherapy care for CLBP. Patients in the experimental group will receive treatment consisting of 12 weeks of physiotherapy with integrated, immersive, multimodal, therapeutic VR. The therapeutic VR consists of the following modules: pain education, activation, relaxation and distraction. The primary outcome measure is physical functioning. Secondary outcome measures include pain intensity, pain-related fears, pain self-efficacy and economic measures. Effectiveness of the experimental intervention compared to the control intervention on primary and secondary outcome measures will be analyzed on an intention-to-treat principle, using linear mixed-model analyses. DISCUSSION: This pragmatic, multicenter cluster randomized controlled trial, will determine the clinical and cost-effectiveness of physiotherapy with integrated, personalized, multimodal, immersive VR in favor of usual physiotherapy care for patients with CLBP. TRIAL REGISTRATION: This study is prospectively registered at ClinicalTrials.gov (identifier: NCT05701891).
KW - Chronic low back pain
KW - Cluster randomized controlled trial (RCT)
KW - Physiotherapy
KW - Study protocol
KW - Virtual reality (VR)
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U2 - 10.1186/s12891-023-06232-0
DO - 10.1186/s12891-023-06232-0
M3 - Article
C2 - 36803315
AN - SCOPUS:85148412118
SN - 1471-2474
VL - 24
SP - 132
JO - BMC musculoskeletal disorders
JF - BMC musculoskeletal disorders
IS - 1
ER -