Mark L van Tilburg1, Corelien J J Kloek2,3, Martijn F Pisters3,4,5, J Bart Staal6,7, Johanna M van Dongen8, Marjolein de Weerd2, Raymond W J G Ostelo8,9, Nadine E Foster10,11, Cindy Veenhof2,3,4. 1. Expertise Center Healthy Urban Living, Research Group Innovation of Human Movement Care, HU University of Applied Sciences Utrecht, Heidelberglaan 7, 3584, CS, Utrecht, the Netherlands. mark.vantilburg@hu.nl. 2. Expertise Center Healthy Urban Living, Research Group Innovation of Human Movement Care, HU University of Applied Sciences Utrecht, Heidelberglaan 7, 3584, CS, Utrecht, the Netherlands. 3. Center for Physical Therapy Research and Innovation in Primary Care, Julius Health Care Centers, Utrecht, the Netherlands. 4. Department of Rehabilitation, Physiotherapy Science and Sports, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. 5. Research Group Empowering Healthy Behaviour, Department of Health Innovations and Technology, Fontys University of Applied Sciences, Eindhoven, the Netherlands. 6. Musculoskeletal Rehabilitation Research Group, HAN University of Applied Sciences, Radboud University Medical Centre, Nijmegen, the Netherlands. 7. Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Center, Nijmegen, the Netherlands. 8. Department of Health Sciences, Faculty of Science, VU University, Amsterdam Movement Sciences Research Institute, Amsterdam, the Netherlands. 9. Department of Epidemiology and Data Science, Amsterdam University Medical Center, Amsterdam Movement Sciences Research Institute, Amsterdam, the Netherlands. 10. Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK. 11. STARS Education and Research Alliance, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.
Abstract
BACKGROUND: Neck and shoulder complaints are common in primary care physiotherapy. These patients experience pain and disability, resulting in high societal costs due to, for example, healthcare use and work absence. Content and intensity of physiotherapy care can be matched to a patient's risk of persistent disabling pain. Mode of care delivery can be matched to the patient's suitability for blended care (integrating eHealth with physiotherapy sessions). It is hypothesized that combining these two approaches to stratified care (referred to from this point as Stratified Blended Approach) will improve the effectiveness and cost-effectiveness of physiotherapy for patients with neck and/or shoulder complaints compared to usual physiotherapy. METHODS: This paper presents the protocol of a multicenter, pragmatic, two-arm, parallel-group, cluster randomized controlled trial. A total of 92 physiotherapists will be recruited from Dutch primary care physiotherapy practices. Physiotherapy practices will be randomized to the Stratified Blended Approach arm or usual physiotherapy arm by a computer-generated random sequence table using SPSS (1:1 allocation). Number of physiotherapists (1 or > 1) will be used as a stratification variable. A total of 238 adults consulting with neck and/or shoulder complaints will be recruited to the trial by the physiotherapy practices. In the Stratified Blended Approach arm, physiotherapists will match I) the content and intensity of physiotherapy care to the patient's risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool) and II) the mode of care delivery to the patient's suitability and willingness to receive blended care. The control arm will receive physiotherapy as usual. Neither physiotherapists nor patients in the control arm will be informed about the Stratified Blended Approach arm. The primary outcome is region-specific pain and disability (combined score of Shoulder Pain and Disability Index & Neck Pain and Disability Scale) over 9 months. Effectiveness will be compared using linear mixed models. An economic evaluation will be performed from the societal and healthcare perspective. DISCUSSION: The trial will be the first to provide evidence on the effectiveness and cost-effectiveness of the Stratified Blended Approach compared with usual physiotherapy in patients with neck and/or shoulder complaints. TRIAL REGISTRATION: Netherlands Trial Register: NL8249 . Officially registered since 27 December 2019. Date of first enrollment: 30 September 2020. Study status: ongoing, data collection.
RCT Entities:
BACKGROUND: Neck and shoulder complaints are common in primary care physiotherapy. These patients experience pain and disability, resulting in high societal costs due to, for example, healthcare use and work absence. Content and intensity of physiotherapy care can be matched to a patient's risk of persistent disabling pain. Mode of care delivery can be matched to the patient's suitability for blended care (integrating eHealth with physiotherapy sessions). It is hypothesized that combining these two approaches to stratified care (referred to from this point as Stratified Blended Approach) will improve the effectiveness and cost-effectiveness of physiotherapy for patients with neck and/or shoulder complaints compared to usual physiotherapy. METHODS: This paper presents the protocol of a multicenter, pragmatic, two-arm, parallel-group, cluster randomized controlled trial. A total of 92 physiotherapists will be recruited from Dutch primary care physiotherapy practices. Physiotherapy practices will be randomized to the Stratified Blended Approach arm or usual physiotherapy arm by a computer-generated random sequence table using SPSS (1:1 allocation). Number of physiotherapists (1 or > 1) will be used as a stratification variable. A total of 238 adults consulting with neck and/or shoulder complaints will be recruited to the trial by the physiotherapy practices. In the Stratified Blended Approach arm, physiotherapists will match I) the content and intensity of physiotherapy care to the patient's risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool) and II) the mode of care delivery to the patient's suitability and willingness to receive blended care. The control arm will receive physiotherapy as usual. Neither physiotherapists nor patients in the control arm will be informed about the Stratified Blended Approach arm. The primary outcome is region-specific pain and disability (combined score of Shoulder Pain and Disability Index & Neck Pain and Disability Scale) over 9 months. Effectiveness will be compared using linear mixed models. An economic evaluation will be performed from the societal and healthcare perspective. DISCUSSION: The trial will be the first to provide evidence on the effectiveness and cost-effectiveness of the Stratified Blended Approach compared with usual physiotherapy in patients with neck and/or shoulder complaints. TRIAL REGISTRATION: Netherlands Trial Register: NL8249 . Officially registered since 27 December 2019. Date of first enrollment: 30 September 2020. Study status: ongoing, data collection.
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