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| Integrating mobile-health, health coaching, and physical activity to reduce the burden of chronic low back pain trial (IMPACT): a pilot randomised controlled trial |
| Amorim AB, Pappas E, Simic M, Ferreira ML, Jennings M, Tiedemann A, Carvalho-E-Silva AP, Caputo E, Kongsted A, Ferreira PH |
| BMC Musculoskeletal Disorders 2019 Feb 11;20(71):Epub |
| clinical trial |
| 7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND: Low back pain is one of the most prevalent musculoskeletal conditions and the highest contributor to disability in the world. It is characterized by frequent relapses leading to additional care-seeking. Engagement in leisure physical activity is associated with lower recurrences and better prognosis and potentially reduced care-seeking. Our aim was to investigate the feasibility and preliminary efficacy of a patient-centred physical activity intervention, supported by health coaching and mobile health, to reduce care-seeking, pain and disability in patients with chronic low back pain after treatment discharge. METHODS: We conducted a pilot randomised controlled trial with blinded outcome assessment. Sixty-eight participants were recruited from four public outpatient physiotherapy departments and the general community in Sydney. The intervention group received a physical activity information booklet, plus one face-to-face and 12 telephone-based health coaching sessions. The intervention was supported by an internet-based application and an activity tracker (Fitbit). Control group (standard care) received the physical activity information booklet and advice to stay active. Feasibility measures included recruitment rate, intervention compliance, data completeness, and participant satisfaction. Primary outcomes were care-seeking, pain levels and activity limitation. Outcomes were assessed at baseline, 6-month follow-up and weekly for 6 months. RESULTS: Ninety potential participants were invited over 15 months, with 68 agreeing to take part (75%). Overall, 903 weekly questionnaires were answered by participants from a total of 1107 sent (89%). Participants were largely satisfied with the intervention (mean 8.7 out of 10 on satisfaction scale). Intervention group participants had a 38% reduced rate of care-seeking (Incidence Rate Ratio (IRR) 0.62, 95% CI 0.32 to 1.18, p = 0.14, using multilevel mixed-effects Poisson regression analysis) compared to standard care, although none of the estimates was statistically significant. No between groups differences were found for pain levels or activity limitation. CONCLUSION: The health coaching physical activity approach trialed here is feasible and well accepted by participants and may reduce care-seeking in patients with low back pain after treatment discharge, although further evaluation with an adequately powered trial is needed. TRIAL REGISTRATION: Australian and New Zealand Trial Registry ACTRN12615000189527. Registered prospectively on 26/02/2015.
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