https://orcid.org/0000-0003-2536-601X
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Abstract
Background
Musculoskeletal (MSK) pain is highly prevalent worldwide, resulting in significant disability, and comorbid sleep disturbances. Digital therapy for MSK pain can provide significant improvements in care access, alongside pain and disability reductions. However, studies on the effect of such programs on sleep are lacking.
Purpose
To evaluate the impact on pain-related sleep impairment after a 12-week remote multimodal digital care program (DCP) for MSK conditions.
Patients and Methods
This is an ad-hoc analysis of a decentralized single-arm study into engagement and clinical outcomes after a DCP for MSK rehabilitation. Patients were stratified by baseline sleep disturbance, based on sleep questions in the questionnaires: Oswestry Disability Index, Neck Disability Index, and the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. Additional outcomes were pain, Generalized Anxiety Disorder 7-item scale, Patient Health 9-item questionnaire, Work Productivity, and Activity Impairment, and program engagement.
Results
At baseline, 5749 patients reported sleep disturbance (78.0% of eligible patients). These reported significantly worse clinical outcomes at baseline than patients without sleep disturbance (all p<0.001). Patients with comorbid sleep disturbance showed improvements in sleep, with a significant proportion reporting full recovery at program completion: 56% of patients with upper limb conditions (including 10% of patients with severe sleep disturbance at baseline), and 24% with spine conditions. These patients also reported significant improvements in all clinical outcomes at program completion. Engagement and satisfaction were high, and also higher than in patients without sleep impairment.
Conclusion
This is the first study of its kind investigating the effect of a completely remote DCP for MSK pain on sleep. Patients reporting comorbid sleep disturbance had significant improvement in sleep, alongside pain, mental health and work productivity at program completion. The results suggest that a DCP for MSK pain can improve sleep disturbances in patients with upper limb and spine conditions.
Abbreviations
MSK, Musculoskeletal; DCP, Digital care program; US, United States; ICHOM, International Consortium for Health Outcomes Measurement; CBT, Cognitive behavioral therapy; PT, Physical Therapist; FDA, United States Food and Drug Administration; BMI, Body Mass Index; QuickDASH, Quick Disabilities of the Arm, Shoulder and Hand questionnaire; NPRS, Numerical Pain Rating Scale; GAD-7, Generalized Anxiety Disorder 7-item scale; PHQ-9, Patient Health 9-item questionnaire; WPAI, Work Productivity and Activity Impairment; ANOVA, Analysis of variance; LGCA, Latent growth curve analysis; FIML, Full information maximum likelihood; NDI, Neck Disability Index; ODI, Oswestry Disability Index; IMMPACT, Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials.
Data Sharing Statement
All data relevant to the study are included in the article or are available as Digital Content at Supplementary Materials. Only de-identified individual participant data is provided. Further information, including the study protocol, can be found at ClinicalTrials.gov (NCT04092946).
Ethics Approval and Informed Consent
The study was approved by the New England IRB (protocol number 120190313) and prospectively registered in ClinicalTrials.gov, NCT04092946, 17/09/2019. This study was conducted in accordance with the approved guidelines. All patients were informed about the purpose and procedures of the study and provided informed consent.
Acknowledgments
The authors acknowledge the team of physical therapists responsible for the management of participants. The authors also acknowledge the contributions of João Tiago Silva and Guilherme Freches in data validation.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
Fabíola Costa, Dora Janela, Maria Molinos, Anabela C. Areias, Virgílio Bento, Vijay Yanamadala and Fernando Dias Correia are employees at Sword Health, the study sponsor. Robert G. Moulder is an independent scientific consultant responsible for statistical analysis, while Jorge Lains and Justin K. Scheer are independent scientific/clinical consultants who were funded by Sword Health in connection with the development and execution of this article. Fernando Dias Correia, Vijay Yanamadala and Virgílio Bento also hold equity from Sword Health. The authors report no other conflicts of interest in this work.