Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial
Vikki Wylde,
Wendy Bertram,
Andrew D. Beswick,
Ashley W. Blom,
Julie Bruce,
Amanda Burston,
Jane Dennis,
Kirsty Garfield,
Nicholas Howells,
Athene Lane,
Candy McCabe,
Andrew J. Moore,
Sian Noble,
Tim J. Peters,
Andrew Price,
Emily Sanderson,
Andrew D. Toms,
David A. Walsh,
Simon White,
Rachael Gooberman-Hill
Affiliations
Vikki Wylde
Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital
Wendy Bertram
Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital
Andrew D. Beswick
Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital
Ashley W. Blom
Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital
Julie Bruce
Warwick Clinical Trials Unit, University of Warwick
Amanda Burston
Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital
Jane Dennis
Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital
Kirsty Garfield
Bristol Randomised Controlled Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol
Nicholas Howells
North Bristol NHS Trust
Athene Lane
Bristol Randomised Controlled Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol
Candy McCabe
Department of Nursing and Midwifery, Faculty of Health and Applied Sciences, University of the West of England
Andrew J. Moore
Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital
Sian Noble
Bristol Randomised Controlled Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol
Tim J. Peters
Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital
Andrew Price
Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Science, University of Oxford
Emily Sanderson
Bristol Randomised Controlled Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol
Andrew D. Toms
Exeter Knee Reconstruction Unit, Royal Devon and Exeter Hospital
David A. Walsh
Arthritis Research UK Pain Centre and NIHR Nottingham BRC, University of Nottingham
Simon White
Cardiff & Vale Orthopaedic Centre, University Hospital Llandough
Rachael Gooberman-Hill
Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Learning and Research Building, Southmead Hospital
Abstract Background Approximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care. Methods This is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability, health-related quality of life and bodily pain. After trial completion, up to 30 patients in the intervention group will be interviewed about their experiences of the care pathway. Discussion If shown to be clinically and cost-effective, this care pathway intervention could improve the management of chronic pain after total knee replacement. Trial registration ISRCTN registry (ISRCTN92545361), prospectively registered on 30 August 2016.
