None listed
Conditions
Brief summary
Musculoskeletal pain is the second leading cause of disease burden in Australia and there is a need to investigate new models of care to cope with increasing demand on health services. This randomised controlled trial (RCT) will investigating whether a physiotherapist-led triage and treatment service is non-inferior for improving function at 6-months, and superior for reducing waiting times, compared to usual clinic-based care for adults with musculoskeletal pain referred to public hospital outpatient physiotherapy clinics. 368 participants (184 per arm) will be recruited from six public hospitals located in metropolitan Sydney, Australia. Adult patients will be eligible as new referrals (referred within the last 6 weeks) to a public hospital physiotherapy outpatient clinic with a musculoskeletal condition or musculoskeletal pain typically managed with physiotherapy. Example referrals include but are not limited to; back or neck pain, osteoarthritis, whiplash-associated disorders, ankle sprains, rehabilitation post-orthopaedic surgery, sporting injury (e.g. ankle sprains). Eligible patients will be randomised to either physiotherapist-led triage and treatment service or usual clinic-based care. The physiotherapist-led triage and treatment service group will be matched to different modes and types of care based on their risk of poor outcome (as assessed by the Keele STarT MSK tool), presence of potential non-progressive radiculopathy or requiring post-operative rehabilitation. The low-risk group will receive a telephone call, the medium risk group will receive telehealth (videoconference) physiotherapy and the high-risk group will receive clinic-based physiotherapy tailored to their presentation. Participants randomised to the usual care group will be offered a course of clinic-based (in-person) physiotherapy as is usually provided at the participating public hospital clinics. Clinic-based physiotherapy may include a combination of any advice and education to support self-management (e.g., advice to exercise, modify activities, lose weight, or take simple pain medications if needed), exercise tailored to patients’ activity goals and level of function, graded activity, graded exposure, and manual therapy. The co-primary outcomes are physical function as assessed by the Patient Specific Functional Scale (PSFS) at 6-months post-randomisation and treatment waiting time (from randomisation to first treatment). Secondary outcomes (e.g. physical function), health resource use (e.g. number of appointments), potential mediators (e.g. pain self-efficacy), process measures (e.g. adherence) and additional outcomes (e.g. harms) will also be assessed.
Interventions
Initial contact with patients referred to the outpatient physiotherapy clinic will be made as soon as possible after a referral is received by a screening physiotherapist via telephone. During this call, patients will be invited to participate in the trial, and will be asked to complete the study consent form and the baseline assessment. A second phone call will inform patients of their group allocation. For participants randomised to the physiotherapist-led triage and treatment service, the scr
Initial contact with patients referred to the outpatient physiotherapy clinic will be made as soon as possible after a referral is received by a screening physiotherapist via telephone. During this call, patients will be invited to participate in the trial, and will be asked to complete the study consent form and the baseline assessment. A second phone call will inform patients of their group allocation. For participants randomised to the physiotherapist-led triage and treatment service, the screening physiotherapist will match them to different modes and types of care during the call informing them of their trial arm allocation. Physiotherapist-led Triage and Treatment Service (Intervention Group) Participants at low risk of poor outcome (Keele STarT MSK tool score 0-4 and absence of potential non-progressive radiculopathy) will be offered brief advice and education via telephone with a physiotherapist. This advice and education (including advice on activity modification, analgesia if necessary and education that condition has a good prognosis) will be provided during the phone call where participants are informed of their trial arm allocation. Participants in this treatment subgroup will be asked to call the screening physiotherapist back if their symptoms have not improved in 6 weeks. Participants will be discharged from the outpatient physiotherapy service if no contact is received after 6 weeks. Participants at medium-risk of poor outcome (Keele STarT MSK tool score 5-8 with absence of potential non-progressive radiculopathy) or requiring post-operative rehabilitation will be offered physiotherapy via telehealth. An appointment with a telehealth physiotherapist will be organised by the screening physiotherapist during the phone call where participants are informed of their trial arm allocation. The duration and frequency of the appointment with the telehealth physiotherapist will be at the discretion of the treating physiotherapist. Telehealth physiotherapy will consist of assessment, advice, education to support self-management, and a tailored home exercise program (via the PhysioTherapy Exercise App - PTX). Physiotherapy treatment forms will be used to monitor adherence and session attendance. Participants at high-risk of poor outcome (Keele STarT MSK tool score 9-12) and/or as having potential non-progressive radiculopathy will be offered a course of clinic-based (in-person) physiotherapy as is usually provided at the participating public hospital clinics. Clinic-based physiotherapy may include a combination of any advice and education to support self-management (e.g., advice to exercise, modify activities, lose weight, or take simple pain medications if needed), exercise tailored to patients’ activity goals and level of function, graded activity, graded exposure, and manual therapy. The duration and frequency of the clinic-based physiotherapy appointments will be at the discretion of the treating physiotherapist. Physiotherapy treatment forms will also be used to monitor adherence and clinic-based session attendance.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adult patient (equal to or greater than 18 years); and - New referral (defined as being referred within the last 6 weeks) to a public hospital physiotherapy outpatient clinic with a musculoskeletal condition or musculoskeletal pain (hereafter referred to as ‘musculoskeletal pain’) that would usually be managed by a physiotherapist. Examples include but are not limited to: o Back/neck pain. o Osteoarthritis. o Whiplash-associated disorders. o Ankle sprains. o Post-fracture. o Sporting injury (e.g. ankle sprains). o Post orthopaedic surgery (e.g. hip or knee replacement, rotator cuff repair surgery); and - Willing to participate and provide follow-up data; and - Can speak and read English to provide informed consent.
Exclusion criteria
- Suspected serious underlying pathology or musculoskeletal conditions requiring urgent medical care (e.g., malignancy, fracture, infection, inflammatory arthritis, joint dislocation); or - Compensable injuries or conditions; or - New referral strongly suggestive of concerning neurological features (e.g., progressive radiculopathy or upper motor neuron lesion); or - Is on a postoperative exercise regimen prescribed by a surgeon that specifies the model of care delivery (e.g., needs to be provided in a clinic supervised by a physiotherapist); or - Requiring mobility progression or assistance weaning from a walking aid(s) whereby the person is at an increased falls risk and needs to be seen in the clinic; or - Pregnant women.
Outcome results
None listed