RecruitingACTRN12624000163505

Stepped physiotherapy for persistent shoulder pain

Stepped physiotherapy for persistent shoulder pain in adults with persistent rotator cuff related shoulder pain


Sponsor

University of Otago

Enrollment

200 participants

Start Date

May 21, 2024

Study Type

Interventional

Conditions

Summary

This study aims to (i) define the effectiveness of a Stepped Care Model for persistent RCRSP compared to usual, pragmatic physiotherapy; (ii) to explore patients’ and the physiotherapists’ perspectives and experiences of the interventions and research processes; (iii) to evaluate the cost-effectiveness of the Stepped Care Model with pragmatic physiotherapy. The Stepped Care Model includes 2 physiotherapy sessions entailing information about shoulder pain and self management. Those that are still symptomatic at 6 weeks following the first session will be offered Pragmatic Physiotherapy. The 'Pragmatic Physiotherapy' group will receive up to 10 sessions within 3 months.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Persistent shoulder pain related to the rotator cuff — the group of tendons and muscles that hold the shoulder joint together — is one of the most common reasons people see a physiotherapist. Most people improve with physiotherapy, but treatment approaches vary widely, and it is unclear whether a simpler 'stepped' approach (starting with less intensive care and only escalating if needed) works as well as immediately offering a full course of physiotherapy. This trial compares a Stepped Care Model — starting with just two sessions focused on education and self-management strategies — against up to 10 sessions of standard physiotherapy from the outset. If patients in the stepped care group still have significant pain after 6 weeks, they are offered the full physiotherapy program. You may be eligible if you are 18 or older, have had shoulder pain for at least 3 months, and the pain is consistent with rotator cuff syndrome. People with a history of shoulder surgery, known inflammatory conditions like rheumatoid arthritis, suspected massive rotator cuff tear, frozen shoulder, or a steroid injection within the past 3 months are not eligible.

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Interventions

Stepped Care will include two one-on-one one-hour physiotherapy sessions of a Self-management programme. The first session will include a ~20-minute clinical assessment of the participant’s pain and t

Stepped Care will include two one-on-one one-hour physiotherapy sessions of a Self-management programme. The first session will include a ~20-minute clinical assessment of the participant’s pain and their goals and preferences. Shared information will relate to their condition/injury; basic pain neuroscience; pain self-management and lifestyle factors (including relaxation, sleep management). General information about exercise and staying active will be provided. A general physical activity (e.g., walking, cycling or gym training) will be recommended (150–300 minutes of moderate-intensity activity per week as per WHO recommendations). During the second session (2-3 weeks later), the physiotherapist will review the participant’s status and physical activity. Person-specific long-term advice will be provided for shoulder health. At 6-week follow-up those no longer experiencing clinically important symptoms at that timepoint (QuickDASH less than 11) will have no further physiotherapy. Those with remaining symptoms (QuickDASH equal or greater than 11) will receive follow-up interventions by the physiotherapist as for Group 2, with up to 8 sessions over 6 weeks (total maximum: 10 sessions). A. What (materials) Patient education: Guided by resources developed and collated by the research team: • Website https://shoulderpain.org.nz/ Exercise prescription: Strength training equipment (free weights, resistance bands). Patient diaries to document goals; progress; physical activity and exercise; pain medication; visits to other health professionals; direct and indirect treatment costs. B. What (procedures): Communication, advice and education The physiotherapist will use a person-centered approach, using a culturally responsive approach to explore the patient’s pain experience, goals and devising a rehabilitation plan; motivational interviewing and reflective listening. The ‘shoulder pain’ website developed at the University of Otago will guide provision of information. Topic sequencing will be individualised to each patient. The therapist will send a link to applicable videos embedded on the website (and others) to patients who will be able to watch them as often as they find helpful. Topics: • Anatomy of the shoulder Surface anatomy of trapezius, deltoid, biceps and triceps muscles; rotator cuff; tendinopathy, partial and full tear; common age-related changes of the rotator cuff. https://shoulderpain.org.nz/your-shoulder/shoulder-anatomy • Connecting with our nervous system The messenger system: neurons, nervous system; the alarm system: sensitivity of the nervous system; factors influencing the alarm system and pain; patterns in the brain (‘neurotags’); factors influenced by the ‘alarm system’ (stress, memory, sleep, concentration, digestion, immunity). https://shoulderpain.org.nz/pain-management/pain-types-and-causes • Managing shoulder pain and wellness with movement: exercise and general physical activity Role of exercise and physical activity towards general health and wellness and desensitising the nervous system; role of specific exercises to strengthen the shoulder; pacing, ‘walking the line’. https://shoulderpain.org.nz/your-shoulder/whole-body-health C. Providers The intervention will be provided by registered physiotherapists (any experience level). They will be trained by the researchers at a one-day workshop, within the month prior to start of recruitment. The Health Behavioural Psychology researcher (Swain), a Maori researcher (Bell), and the principal investigator (Sole) will train the clinicians for the therapeutic relationship/cognitive skills, cultural responsiveness and the manual therapy/exercise and physical activity programme. Follow-up sessions will be held with the principal investigator via Zoom or in person. D. How Two face-to-face, one-on-one physiotherapy sessions and self-directed physical activity. E. Where • University of Otago School of Physiotherapy clinics, Dunedin • Christchurch Physiotherapy and Sports Clinic, Christchurch • Auckland Shoulder Clinic, Auckland • Focused Physiotherapy, Waikato F. When and how much Recruitment is planned from April 2024 to April 2025. Physiotherapy care will be provided 2 one-hour sessions within three weeks. Patients will be followed up at 6 weeks those with remaining symptoms (based on the threshold QuickDASH score) will be offered physiotherapy, as for the ‘Pragmatic Physiotherapy’ Group (see below). and across a three-month period: two of them will be one hour, and the remaining ones ½-hour duration. The frequency of the sessions across the three-month period will be based on the physiotherapist’s and patients’ collaborative decision. G. Tailoring A pragmatic approach will be used, tailored to the patients’ clinical presentation and approach. Education: the information provided to the patient will be dependent on the line of the conversations and questions asked by the patient. Prescription of general physical activity (e.g. walking, cycling, gym training) will be based on the patient’s interest, past activity level, as well as current tolerance, for example, walking 15 minutes daily. The goal will be to achieve WHO guidelines for physical activity (150-300 minutes of moderate-intensity activity per week). Participants will be asked to record their physical activity in an electronic or hard copy diary on a weekly basis. H. Modifications Any modifications to the protocol will be documented and reported. I. Safety • Pain flare ups. The physiotherapist will discuss with the participant what level of discomfort or pain might be expected during physical activity. In most cases such acvitiy-related discomfort/pain settles within 24 hours. If it lasts longer than 24 hours and the participant considers the discomfort/pain excessive, they will be asked to avoid the specific activity and report that back to the physiotherapist. The Physiotherapist will record such response in the clinical notes during the second session, and modify the physical at a lower intensity. If participants have severe or untolerable pain at any time during the three months following the first session, they will be able to contact the physiotherapist and be offered to enter the ‘Pragmatic Physiotherapy’ programme, as below.


Locations(1)

New Zealand

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ACTRN12624000163505