Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2020

01-12-2020 | Knee Osteoarthritis | Study protocol

Technology versus tradition: a non-inferiority trial comparing video to face-to-face consultations with a physiotherapist for people with knee osteoarthritis. Protocol for the PEAK randomised controlled trial

Authors: Rana S. Hinman, Alexander J. Kimp, Penny K. Campbell, Trevor Russell, Nadine E. Foster, Jessica Kasza, Anthony Harris, Kim L. Bennell

Published in: BMC Musculoskeletal Disorders | Issue 1/2020

Login to get access

Abstract

Background

Knee osteoarthritis (OA) is a global problem that causes significant pain and physical dysfunction, substantially impacting on quality of life and imposing enormous cost to the healthcare system. Exercise is pivotal to OA management, yet uptake by people with knee OA is inadequate. Limited access to appropriately skilled health professionals, such as physiotherapists, for prescription of an exercise program and support with exercise is a major barrier to optimal care. Internet-enabled video consultations permit widespread reach. However, services offering video consultations with physiotherapists for musculoskeletal conditions are scant in Australia where there is typically no Government or private health insurer funding for such services. The paucity of robust evidence demonstrating video consultations with physiotherapists are clinically effective, safe and cost-effective for knee OA is hampering implementation of, and willingness of healthcare policymakers to pay for, these services.

Methods

This is an assessor- and participant-blinded, two-arm, pragmatic, comparative effectiveness non-inferiority randomised controlled trial (RCT) conducted in Australia. We are recruiting 394 people from the community with chronic knee pain consistent with a clinical diagnosis of knee OA. Participants are randomly allocated to receive physiotherapy care via i) video-conferencing or; ii) face-to-face consultations. Participants are provided five consultations (30–45 min each) with a physiotherapist over 3 months for prescription of a home-based strengthening exercise program (to be conducted independently at home) and physical activity plan, as well as OA education. Participants in both groups are provided with educational booklets and simple exercise equipment via post. The co-primary outcomes are change in self-reported i) knee pain on walking; and ii) physical function, with a primary end-point of 3 months and a secondary end-point of 9 months. Secondary outcomes include changes in other clinical outcomes (health-related quality of life; therapeutic relationship; global ratings of change; satisfaction with care; self-efficacy; physical activity levels), time and financial costs of attending consultations, healthcare usage and convenience. Non-inferiority will be assessed using the per-protocol dataset.

Discussion

Findings will determine if video consultations with physiotherapists are non-inferior to traditional face-to-face consultations for management of people with knee OA.

Trial registration

Literature
1.
Arthritis and Osteoporosis Victoria: A Problem Worth Solving. The rising cost of musculoskeletal conditions in Australia; 2013.
2.
Global Burden of Disease 2017 Disease and Injury Incidence and Prevalence Collaborators: Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the global burden of disease study 2017. Lancet. 2018;392(10159):1789–858.
3.
Safiri S, Kolahi AA, Smith E, Hill C, Bettampadi D, Mansournia MA, Hoy D, Ashrafi-Asgarabad A, Sepidarkish M, Almasi-Hashiani A, et al. Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the global burden of disease study 2017. Ann Rheum Dis. 2020;79(6):819–28.PubMedCrossRef
4.
Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, et al. EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013;72(7):1125–35.PubMedCrossRef
5.
Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthr Cartil. 2019;27(11):1578–89.CrossRef
6.
National Clinical Guideline Centre: Osteoarthritis. Care and management in adults. Clinical guideline CG177. Methods, evidence and recommendations: London, National Institute for Health and Care Excellence (UK); 2014.
7.
The Royal Australian College of General Practitioners. Guideline for the management of knee and hip osteoarthritis. 2nd ed. East Melbourne: RACGP; 2018.
8.
Fransen M, McConnell S, Harmer AR, van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2015;1:CD004376.PubMed
9.
Uthman OA, van der Windt DA, Jordan JL, Dziedzic KS, Healey EL, Peat GM, Foster NE. Exercise for lower limb osteoarthritis: systematic review incorporating trial sequential analysis and network meta-analysis. Bmj. 2013;347:f5555.PubMedPubMedCentralCrossRef
10.
Hinman RS, Hunt M, Simic M, Bennell KL. Exercise, gait retraining, footwear and insoles for knee osteoarthritis. Curr Phys Med Rehabil Rep. 2013;1:21–8.CrossRef
11.
Bennell KL, Nelligan R, Dobson F, Rini C, Keefe F, Kasza J, French S, Bryant C, Dalwood A, Abbott JH, et al. Effectiveness of an internet-delivered exercise and pain-coping skills training intervention for persons with chronic knee pain: a randomized trial. Ann Intern Med. 2017;166(7):453–62.PubMedCrossRef
12.
Hinman RS, Nelligan RK, Bennell KL, Delany C. "sounds a bit crazy, but it was alsmost more personal:" a qualtitative study of patient and clinician experiences of physical therapist-prescribed exercise for knee osteoarthritis via skype. Arthritis Care Res. 2017;69:1834–44.CrossRef
13.
Lawford BJ, Bennell KL, Hinman RS. Consumer perceptions of and willingness to use remotely delivered service models for exercise management of knee and hip osteoarthritis: a cross-sectional survey. Arthritis Care Res. 2016;69(5):667–76.CrossRef
14.
Cottrell MA, Hill AJ, O'Leary SP, Raymer ME, Russell TG. Patients are willing to use telehealth for the multidisciplinary management of chronic musculoskeletal conditions: a cross sectional survey. J Telemed Telecare. 2018;24(7):445–52.PubMedCrossRef
15.
Russell TG, Buttrum P, Wootton R, Jull GA. Internet-based outpatient telerehabilitation for patients following total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg (Am Vol). 2011;93(2):113–20.CrossRef
16.
Chan A, Tetzlaff JM, Altman DG, et al. Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.PubMedPubMedCentralCrossRef
17.
Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG, Group C. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012;308(24):2594–604.PubMedCrossRef
18.
Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, Group CN. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med. 2017;167(1):40–7.PubMedCrossRef
19.
Exercise and Sports Science Australia: Adult Pre-exercise Screening System; 2012.
20.
Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6:42.PubMedPubMedCentralCrossRef
21.
Michie S, Ashford S, Sniehotta FF, Dombrowski SU, Bishop A, French DP. A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy. Psychol Health. 2011;26(11):1479–98.PubMedCrossRef
22.
Nicolson PJA, Hinman RS, French SD, Lonsdale C, Bennell KL. Improving adherence to exercise: do people with knee osteoarthritis and physical therapists agree on the behavioral approaches likely to succeed? Arthritis Care Res. 2018;70(3):388–97.CrossRef
23.
Bennell KL, Hunt MA, Wrigley TV, Hunter DJ, McManus FJ, Hodges PW, Li L, Hinman RS. Hip strengthening reduces symptoms but not knee load in people with medial knee osteoarthritis and varus malalignment: a randomised controlled trial. Osteoarthr Cartil. 2010;18(5):621–8.CrossRef
24.
Bennell KL, Kyriakides M, Metcalf B, Egerton T, Wrigley TV, Hodges PW, Hunt MA, Roos EM, Forbes A, Ageberg E, et al. Neuromuscular versus quadriceps strengthening exercise in patients with medial knee osteoarthritis and varus malalignment: a randomized controlled trial. Arthritis Rheum. 2014;66(4):950–9.CrossRef
25.
Lim BW, Hinman RS, Wrigley TV, Sharma L, Bennell KL. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis Rheum. 2008;59(7):943–51.PubMedCrossRef
26.
Bennell KL, Campbell PK, Egerton T, Metcalf B, Kasza J, Forbes A, Bills C, Gale J, Harris A, Kolt GS, et al. Telephone coaching to enhance a home-based physical activity program for knee osteoarthritis: a randomised clinical trial. Arthritis Care Res. 2017;69(1):84–94.CrossRef
27.
Hinman RS, Campbell PK, Lawford BJ, Briggs AM, Gale J, Bills C, Kasza J, Harris A, French SD, Bunker SJ, et al. Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial. Br J Sports Med. 2019;bjsports(2019):101183. https://​doi.​org/​10.​1136/​bjsports-2019-101183.CrossRef
28.
Borg G, Ljunggren G, Ceci R. The increase of perceived exertion, aches and pain in the legs, heart rate and blood lactate during exercise on a bicycle ergometer. Eur J Appl Physiol Occup Physiol. 1985;54(4):343–9.PubMedCrossRef
29.
Pescatello LS. ACSM’s guidelines for exercise testing and prescription. Ninth edition. edn: Wolters Kluwer/Lippincott Williams & Wilkins Health; 2014.
30.
31.
Prasanna SS, Korner-Bitensky N, Ahmed S. Why do people delay accessing health care for knee osteoarthritis? Exploring beliefs of health professionals and lay people. Physiother Can. 2013;65(1):56–63.PubMedPubMedCentralCrossRef
32.
Thorstensson CA, Gooberman-Hill R, Adamson J, Williams S, Dieppe P. Help-seeking behaviour among people living with chronic hip or knee pain in the community. BMC Musculoskelet Disord. 2009;10:153.PubMedPubMedCentralCrossRef
33.
Edwards JJ, Khanna M, Jordan KP, Jordan JL, Bedson J, Dziedzic KS. Quality indicators for the primary care of osteoarthritis: a systematic review. Ann Rheum Dis. 2015;74(3):490–8.PubMedCrossRef
34.
Edwards JJ, Jordan KP, Peat G, Bedson J, Croft PR, Hay EM, Dziedzic KS. Quality of care for OA: the effect of a point-of-care consultation recording template. Rheumatol. 2015;54(5):844–53.CrossRef
35.
Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, Altman R, Brandt K, Dougados M, Lequesne M. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol. 1997;24(4):799–802.PubMed
36.
McAlindon TE, Driban JB, Henrotin Y, Hunter DJ, Jiang GL, Skou ST, Wang S, Schnitzer T. OARSI clinical trials recommendations: design, conduct, and reporting of clinical trials for knee osteoarthritis. Osteoarthr Cartil. 2015;23(5):747–60.CrossRef
37.
Bellamy N. Osteoarthritis clinical trials: candidate variables and clinimetric properties. J Rheumatol. 1997;24(4):768–78.PubMed
38.
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833–40.PubMed
39.
McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster universities osteoarthritis index (WOMAC): a review of its utility and measurement properties. Arthritis Rheum. 2001;45(5):453–61.PubMedCrossRef
40.
Osborne RH, Hawthorne G, Lew EA, Gray LC. Quality of life assessment in the community-dwelling elderly: validation of the assessment of quality of life (AQoL) instrument and comparison with the SF-36. J Clin Epidemiol. 2003;56(2):138–47.PubMedCrossRef
41.
Martin K, Rejeski W, Miller M, James M, Ettinger W Jr, Messier S. Validation of the PASE in older adults with knee pain and physical disability. Med Sci Sports Exerc. 1999;31(5):627–33.PubMedCrossRef
42.
Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989;32(1):37–44.PubMedCrossRef
43.
ten Klooster PM, Drossaers-Bakker KW, Taal E, van de Laar MA. Patient-perceived satisfactory improvement (PPSI): interpreting meaningful change in pain from the patient's perspective. Pain. 2006;121(1–2):151–7.PubMedCrossRef
44.
Horvath AO, Greenberg LS. Development and validation of the working Alliance inventory. J Couns Psychol. 1989;36(2):223–33.CrossRef
45.
Sangha O, Stucki G, Liang MH, Fossel AH, Katz JN. The self-administered comorbidity questionnaire: a new method to assess comorbidity for clinical and health services research. Arthritis Rheum. 2003;49(2):156–63.PubMedCrossRef
46.
Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004;8(4):283–91.PubMedCrossRef
47.
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–58.PubMedCrossRef
48.
Bellamy N, Carette S, Ford P, Kean W, le Riche N, Lussier A, Wells G, Campbell J. Osteoarthritis antirheumatic drug trials. II. Tables for calculating sample size for clinical trials. J Rheumatol. 1992;19(3):1992.
49.
Zhang H, Zhang K, Zhang X, Zhu Z, Yan S, Sun T, Guo A, Jones J, Steen RG, Shan B, et al. Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: a multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz. Arthritis Res Ther. 2015;17:51.PubMedPubMedCentralCrossRef
50.
Ehrich EW, Davies GM, Watson DJ, Bolognese JA, Seidenberg BC, Bellamy N. Minimal perceptible clinical improvement with the Western Ontario and McMaster universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol. 2000;27(11):2635–41.PubMed
51.
Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005;64(1):29–33.PubMedCrossRef
52.
Losina E, Ranstam J, Collins JE, Schnitzer TJ, Katz JN. OARSI clinical trials recommendations: key analytic considerations in design, analysis, and reporting of randomized controlled trials in osteoarthritis. Osteoarthr Cartil. 2015;23(5):677–85.CrossRef
53.
Wiens BL. Multiple comparisons in non-inferiority trials: reaction to recent regulatory guidance on multiple endpoints in clinical trials. J Biopharm Stat. 2018;28(1):52–62.PubMedCrossRef
54.
55.
56.
Foster NE, Delitto A. Embedding psychosocial perspectives within clinical management of low back pain: integration of psychosocially informed management principles into physical therapist practice--challenges and opportunities. Phys Ther. 2011;91(5):790–803.PubMedCrossRef
57.
58.
Cottrell MA, Galea OA, O'Leary SP, Hill AJ, Russell TG. Real-time telerehabilitation for the treatment of musculoskeletal conditions is effective and comparable to standard practice: a systematic review and meta-analysis. Clin Rehabil. 2017;31(5):625–38. https://​doi.​org/​10.​1177/​0269215516645148​.
59.
Salisbury C, Montgomery AA, Hollinghurst S, Hopper C, Bishop A, Franchini A, Kaur S, Coast J, Hall J, Grove S, et al. Effectiveness of PhysioDirect telephone assessment and advice services for patients with musculoskeletal problems: pragmatic randomised controlled trial. BMJ. 2013;346:f43.PubMedPubMedCentralCrossRef
60.
Australasian Telehealth Society: National Digital Health Strategy; 2017.
61.
Australasian Telehealth Society: Towards a National Strategy for telehealth in Australia 2013–2018; 2013.
Metadata
Title
Technology versus tradition: a non-inferiority trial comparing video to face-to-face consultations with a physiotherapist for people with knee osteoarthritis. Protocol for the PEAK randomised controlled trial
Authors
Rana S. Hinman
Alexander J. Kimp
Penny K. Campbell
Trevor Russell
Nadine E. Foster
Jessica Kasza
Anthony Harris
Kim L. Bennell
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2020
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-020-03523-8

Other articles of this Issue 1/2020

BMC Musculoskeletal Disorders 1/2020 Go to the issue

Study protocol

The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protocol of a randomized, double blind, placebo-controlled, multicenter trial

Research article

Differential proteomic analysis of fetal and geriatric lumbar nucleus pulposus: immunoinflammation and age-related intervertebral disc degeneration

Research article

Screw fixation in stemless shoulder arthroplasty for the treatment of primary osteoarthritis leads to less osteolysis when compared to impaction fixation

Research article

Modular stem in total hip arthroplasty for patients with trochanter valgus deformity: surgical technique and case series

Research article

Work- and stress-related musculoskeletal and sleep disorders among health professionals: a cross-sectional study in a hospital setting in Switzerland

Research article

Augmented reality guided osteotomy in hallux Valgus correction