Internet-delivered primary care for rotator cuff-related shoulder pain (RCRSP) with or without telehealth support: a randomised controlled trial (the INTEL trial)

Following randomisation, participants will either (1) continue with their usual care, (2) continue with their usual care plus be offered the INTEL internet intervention, or (3) continue with their usual care plus be offered the INTEL internet intervention AND telehealth support by a physiotherapist. The interventions for groups (2) and (3) are described below. (2) Usual care + INTEL internet intervention In addition to usual care, participants will be offered an unsupervised, self-directed internet-based intervention grounded in behaviour change theory containing education and exercise components. Participants will gain access to a login-protected website where the intervention content will be provided. The content (six modules in total) will be delivered over a 12-week period. In week 1, participants will receive access to module 1, while modules 2-6 will remain locked. In week 2, module 2 will be released and the remaining modules (modules 3-6) will also become available on the website. The core and mandatory intervention content, which includes education on shoulder pain, activity modification, and therapeutic exercise components (see details below), will be introduced in modules 1 and 2. Participants will receive fortnightly reminders informing them that modules 3-6 are available and encouraging them to access the content on the INTEL website. The website will feature a dedicated section for each module’s content, designed like a slide deck, allowing participants to navigate by clicking through the content pages. The slide deck will be narrated. After the release of the two core modules in weeks 1 and 2, respectively, participants will have the option to download a PDF file for each module (modules 1–6) for offline use. This option will be available on the website regardless of whether the participants have completed the core online modules and will extend to all subsequent modules. At the end of each online module, participants will be prompted to reflect on and record their key takeaways or insights (learning) from the content in that module, as well as review their goals and action plan. The recorded information will be used for process evaluation purposes. Participants will be able to work through the modules at their own pace. A 'Contact us' button will be available on the website for participants to report any technological issues they encounter while navigating it. The core educational content delivered in Module 1 will focus on reassuring participants that tissue changes are not necessarily associated with pain, discussing the benefits and harms of treatment options, addressing the unnecessary use of imaging, and introducing the concept of pain acceptance. The module will include advice on how participants can modify their usual activities when pain is limiting them. Using pictures and videos, we will demonstrate modifications for reaching behind, sleeping, and overhead activities. Participants will be encouraged to select goals, complete an online action plan outlining what changes they will make, and track the progress that they record on the INTEL website based on what evidence they are seeing towards their goal. If they are not seeing progress towards their goals when they review them, they will be offered automated advice troubleshooting adherence barriers (if relevant). Depending on the goal selected and progress reported, participants will be prompted to continue to have reduced activity, or reduce further, continue with the same activity, or gradually progress their activity. The core exercise component, delivered in Module 2, will instruct participants to perform shoulder exercises. Exercises will be grouped into three categories: elevation (e.g., raising the arms with a looped band or using a weight), push (e.g., pushing against a wall, bench, or chair), and rotation (e.g., external rotation using a band or weights). Each category will contain a target exercise with options to make it easier or harder depending on the response for an individual participant. Participants will be instructed to perform 8 to 10 repetitions of each exercise, 3 times per week. The exercises will be demonstrated in pictures and videos on the website. Instructions will cover exercise regression and progression based on an 'acceptable pain response' and exercise intensity. Therabands will be sent to participants. Participants will be instructed to regress the exercise if the pain is not acceptable or if it feels too hard (9 or 10 out of 10 on the exercise intensity scale). They will be instructed to progress the exercise when pain is acceptable or if it feels too easy (5 or less out of 10 on the exercise intensity scale). Acceptable pain will be defined as pain that is tolerable for them. A caveat will be added to say that this is usually considered to be mild to moderate on a categorical scale that includes mild, moderate and severe options. Participants will be instructed on the targeted exercise intensity and equipment that they can use to perform the exercises (e.g., adapt household items to serve as weights). The goal for participants is to ensure they have acceptable pain and the exercise is challenging enough. To ensure adequate challenge, there are simple options for progression depending on where they are on the continuum of the exercises. Other relevant content will be provided in modules 3 to 6. (3) Usual care + INTEL internet intervention + telehealth support by a physiotherapist Participants in Group 3 of the INTEL trial, in addition to their usual care and the INTEL internet intervention (identical to Group 2), will be offered up to six individual telehealth sessions with a physiotherapist via Zoom. If a participant feels they do not require all six sessions, the sessions may be discontinued early. The physiotherapist will record this. Once allocated to group (3) participants will be sent an email asking about their preferred times for telehealth sessions. This information will be used to match them with a physiotherapist delivering telehealth. The session will be scheduled as soon as possible, ideally within one week and no later than two weeks after randomisation. Telehealth sessions, each lasting a maximum of 30 minutes, aim to support participants in using the INTEL internet intervention and working toward their goals. The physiotherapists in the trial will be trained to troubleshoot issues with the INTEL website, address participants' questions, and monitor, encourage, and provide feedback on participants' goals and exercise performance. During the telehealth sessions, participants will be able to practice the prescribed exercises, if they wish, and receive advice from the physiotherapist on exercise regression or progression. While telehealth physiotherapists are able to address individual participant concerns, they are asked to avoid additional individualised participant assessment and treatment recommendations beyond the internet intervention content. In the email sent to the participant after randomisation, as described above, the research team will inform participants of the purpose of the telehealth sessions and guide them on setting up the environment (e.g., best device to use and how to position it). All physiotherapists delivering telehealth will be asked to attend two online training sessions, complete one individual role-play session, and review the intervention materials (e.g., website, PDF modules), totalling approximately 8 hours of training. During the role-play, they will deliver a telehealth consultation to a member of the research team acting as a trial participant, prior to the trial. They will receive feedback on areas they performed well in and areas for improvement. Physiotherapists will also be asked to join a Google Space forum, where they can ask questions and access relevant materials (e.g., training slides, troubleshooting guides). They will be instructed to contact the research team to report any challenges and seek support whenever needed.