Evaluation of implementation and effectiveness of neck-specific exercise for persistent disability and pain after whiplash injury: study protocol for a randomized controlled study using a hybrid 2 design

Background: Persistent pain and disability in whiplash-associated disorders (WAD) grades II and III are common. In two randomized controlled trials (RCTs) of neck-specific exercises (NSE), we have seen promising results in chronic WAD, with a sustained clinically important reduction in pain and disability. NSE can also be delivered through internet support (NSEIT) and a few visits to a physiotherapist, saving time and cost for both patients and providers. NSE have been shown to have positive effects in other neck pain disorders and we will evaluate the diffusion of the exercises to other patients. The aims of the proposed study are to evaluate an implementation strategy for NSEIT and NSE in primary health care and to evaluate the effectiveness of NSEIT and NSE in clinical practice.

Methods: The proposed study is a prospective cluster-randomized mixed-design study with hybrid 2 trial design. Reg. physiotherapists working in twenty physiotherapy clinics will be included. The primary implementation outcome is proportion of patients with neck pain receiving neck-specific exercise. Secondary outcomes are; physiotherapists attitudes to implementation of evidence-based practice, their self-efficacy and confidence in performing NSEIT/NSE, number of patients visits, and use of additional or other exercises or treatment. To further evaluate the implementation strategy, two qualitative studies will be performed with a sample of the physiotherapists. The primary outcome in the patient effectiveness evaluation is self-reported neck disability according to the Neck Disability Index (NDI). Secondary outcomes are pain intensity in the neck, arm, and head; dizziness; work- and health-related issues; and patient's improvement or deterioration over time. All measurements will be conducted at baseline and at 3 and 12 months. Physiotherapists´ self-efficacy and confidence in diagnosing and treating patients with neck pain will also be evaluated directly after their instruction in NSEIT/NSE.

Discussion: This trial will evaluate the implementation strategy in terms of adoption of and adherence to NSEIT and NSE in clinical primary health care, and measure diffusion of the method to other patients. In parallel, the effectiveness of the method will be evaluated. The results may guide physiotherapists and health care providers to sustainable and effective implementation of effective exercise programs.

Trial registration: The randomized trial is registered on ClinicalTrials.gov , NCT05198258 , initial release date January 20, 2022.