Efficacy of Telerehabilitation Exercise in Patients with Chronic Neck Pain: A Protocol for a Non-Inferiority Randomized Controlled Trial

Abstract

The aim of this study is to investigate if telerehabilitation is just as effective as the same face-to-face exercise program in patients with chronic neck pain (NP). 140 participants will participate in this non-inferiority randomized controlled trial. Primary outcomes will be pain intensity and disability, and secondary outcomes will be kinesiophobia, catastrophizing, fear avoidance beliefs, anxiety and depression symptoms, self-efficacy for pain and global perceived effect. It will be collected at baseline, 6 weeks and 6 months after intervention. The analysis of non-inferiority will be calculated by mixed linear models considering the non-inferiority margin. The results of this clinical trial will be able to overcome the barriers that physiotherapists face for the success of their therapies. In addition, it may reduce the high demands and public health costs with NP. Brazilian Clinical Trials Registry (RBR-6VBSMB).

Clinical Trial Registration: REBEC (Brazilian Registry of Clinical Trials) RBR-6VBSMB (ClinicalTrials.gov)

Plain language summary

What is this article about?

This study aims to compare the effect of face-to-face and telerehabilitation treatment for chronic neck pain, since it is the third condition that causes most disability in the world among musculoskeletal conditions. In addition, because its prevalence occurs at an economically active age, it generates a drop in productivity and absenteeism at work. Due to the high public health expenses with chronic neck pain, telerehabilitation is a tool with great potential for reducing waiting lists and barriers to therapy success (transport, time, money).

What do the results of the study mean?

This is the first clinical trial to investigate the efficacy of telerehabilitation exercise in patients with chronic neck pain and the results will be able to overcome the barriers that physiotherapists face for the success of their therapies. In addition, it may reduce the high demands and public health costs with neck pain and may help patients experience less pain and disability and become more self-sufficient in managing their chronic condition.

Tweetable abstract

The first clinical trial to investigate if telerehabilitation exercise in patients with chronic neck pain is just as effective as face-to-face exercise and the results will be able to overcome the barriers that physiotherapists face for the success of their therapies.

Keywords::

• catastrophization
• chronic pain
• exercise therapy
• kinesiophobia
• neck pain
• telerehabilitation

Author contributions

Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work: GLN Antonio, MQ Almeida, MAA Vera, M Amaral de Noronha, LF Approbato Selistre.

Drafting the work or revising it critically for important intellectual content: GLN Antonio, MQ Almeida, MAA Vera, M Amaral de Noronha, LF Approbato Selistre.

All authors approved the final version of the manuscript and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All persons designated as authors qualify for authorship, and all those who qualify for authorship are listed.

Acknowledgments

The authors would like to thank the National Council for Scientific and Technological Development (CNPq) and Coordination for the Improvement of Higher Education Personnel - Brazil (CAPES).

Financial disclosure

GLN Antonio had been supported by the Conselho Nacional de Desenvolvimento Científico e Tecnológico – CNPq (National Council for Scientific and Technological Development, CNPq), through a scholarship for undergraduate students of physical therapy (Grant number: 800939/2018-2). Currently, she has been supported by the Coordination for the Improvement of Higher Education Personnel - Brazil (CAPES) (Grant number: 88887716363/2022-00). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Additional information

Funding

GLN Antonio had been supported by the Conselho Nacional de Desenvolvimento Científico e Tecnológico – CNPq (National Council for Scientific and Technological Development, CNPq), through a scholarship for undergraduate students of physical therapy (Grant number: 800939/2018-2). Currently, she has been supported by the Coordination for the Improvement of Higher Education Personnel - Brazil (CAPES) (Grant number: 88887716363/2022-00). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.