M Arora1,2, L A Harvey1,2, J V Glinsky1,2, H S Chhabra3, S Hossain4, N Arumugam5, P K Bedi5, L Lavrencic6, A J Hayes7, I D Cameron1,2. 1. John Walsh Centre for Rehabilitation Research, Kolling Institute of Medical Research, Northern Sydney Local Health District, St Leonards, New South Wales, Australia. 2. Sydney Medical School Northern, University of Sydney, Sydney, New South Wales, Australia. 3. Department of Spine Service, Indian Spinal Injuries Centre, Delhi, India. 4. Centre for Rehabilitation of the Paralysed, Savar, Bangladesh. 5. Department of Physiotherapy, Punjabi University, Patiala, India. 6. Spinal Cord Injury Unit, Royal North Shore Hospital, St Leonards, New South Wales, Australia. 7. School of Public Health, University of Sydney, Sydney, New South Wales, Australia.
Abstract
STUDY DESIGN: A multicentre, prospective, assessor-blinded, parallel randomised controlled trial. OBJECTIVES: The objective of the trial was to determine the effectiveness of telephone-based management of pressure ulcers in people with spinal cord injury (SCI) in low- and middle-income countries. METHODS:One hundred and twenty people with SCI living in the community were recruited through three hospitals in India and Bangladesh between November 2013 and March 2016. Participants had sustained an SCI >3 months prior and had a pressure ulcer. Participants were randomly allocated (1:1) to a control or intervention group. Participants in the control group received no intervention. Participants in the intervention group received weekly advice by telephone for 12 weeks about the management of their pressure ulcers from a trained health-care professional. Outcomes were measured by a blinded assessor at baseline and 12 weeks. There was one primary outcome, namely, the size of the pressure ulcer and 13 secondary outcomes. RESULTS: The mean between-group difference for the size of the pressure ulcer at 12 weeks was 2.3 cm2 (95% confidence interval -0.3 to 4.9; favouring the intervention group). Eight of the 13 secondary outcomes were statistically significant. CONCLUSION: The results of our primary outcome (that is, size of pressure ulcer) do not provide conclusive evidence that people with SCI can be supported at home to manage their pressure ulcers through regular telephone-based advice. However, the results from the secondary outcomes are sufficiently positive to provide hope that this simple intervention may provide some relief from this insidious problem in the future.
RCT Entities:
STUDY DESIGN: A multicentre, prospective, assessor-blinded, parallel randomised controlled trial. OBJECTIVES: The objective of the trial was to determine the effectiveness of telephone-based management of pressure ulcers in people with spinal cord injury (SCI) in low- and middle-income countries. METHODS: One hundred and twenty people with SCI living in the community were recruited through three hospitals in India and Bangladesh between November 2013 and March 2016. Participants had sustained an SCI >3 months prior and had a pressure ulcer. Participants were randomly allocated (1:1) to a control or intervention group. Participants in the control group received no intervention. Participants in the intervention group received weekly advice by telephone for 12 weeks about the management of their pressure ulcers from a trained health-care professional. Outcomes were measured by a blinded assessor at baseline and 12 weeks. There was one primary outcome, namely, the size of the pressure ulcer and 13 secondary outcomes. RESULTS: The mean between-group difference for the size of the pressure ulcer at 12 weeks was 2.3 cm2 (95% confidence interval -0.3 to 4.9; favouring the intervention group). Eight of the 13 secondary outcomes were statistically significant. CONCLUSION: The results of our primary outcome (that is, size of pressure ulcer) do not provide conclusive evidence that people with SCI can be supported at home to manage their pressure ulcers through regular telephone-based advice. However, the results from the secondary outcomes are sufficiently positive to provide hope that this simple intervention may provide some relief from this insidious problem in the future.
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