Clinical Trial

Original Investigation| Orthopedics Effectiveness of Internet-Based Exercises Aimed at Treating Knee Osteoarthritis The iBEAT-OA Randomized Clinical Trial Sameer Akram Gohir, MSc, PhD; Frida Eek, PhD; Anthony Kelly, PhD; Abhishek Abhishek, PhD; Ana M. Valdes, PhD Abstract IMPORTANCEOsteoarthritis is a prevalent, debilitating, and costly chronic disease for which recommended first-line treatment is underused. OBJECTIVETo compare the effect of an internet-based treatment for knee osteoarthritis vs routine self-management (ie, usual care). DESIGN, SETTING, AND PARTICIPANTSThis randomized clinical trial was conducted from October 2018 to March 2020. Participants included individuals aged 45 years or older with a diagnosis of knee osteoarthritis recruited from an existing primary care database or from social media advertisements were invited. Data were analyzed April to July 2020. INTERVENTIONSThe intervention and control group conformed to first-line knee osteoarthritis treatment. For the intervention group, treatment was delivered via a smartphone application. The control group received routine self-management care. MAIN OUTCOMES AND MEASURESThe primary outcome was change from baseline to 6 weeks in self-reported pain during the last 7 days, reported on a numerical rating scale (NRS; range, 0-10, with 0 indicating no pain and 10, worst pain imaginable), compared between groups. Secondary outcomes included 2 physical functioning scores, hamstring and quadriceps muscle strength, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and quantitative sensory testing. RESULTSAmong a total of 551 participants screened for eligibility, 146 were randomized and 105 were analyzed (mean [SD] age, 66.7 [9.2] years, 71 [67.1%] women), including 48 participants in the intervention group and 57 participants in the control group. There were no significant differences in baseline characteristics between the groups. At the 6-week follow-up, the intervention group showed a greater NRS pain score reduction than the control group (between-group difference, −1.5 [95% CI, −2.2 to −0.8];P< .001). Similarly, the intervention group had better improvements in the 30-second sit-to-stand test (between-group difference, 3.4 [95% CI, 2.2 to 4.5];P< .001) and Timed Up-and-Go test (between-group difference, −1.8 [95% CI, −3.0 to −0.5] seconds;P= .007), as well as the WOMAC subscales for pain (between-group difference, −1.1 [95% CI, −2.0 to −0.2];P= .02), stiffness (between-group difference, −1.0 [95% CI, −1.5 to −0.5];P< .001), and physical function (between-group difference, −3.4 [95% CI, −6.2 to −0.7];P= .02). The magnitude of within-group changes in pain (d= 0.83) and function outcomes (30 second sit-to-stand testd= 1.24; Timed Up-and-Go testd= 0.76) in the intervention group corresponded to medium to very strong effects. No adverse events were reported. CONCLUSIONS AND RELEVANCEThese findings suggest that this internet-delivered, evidence- based, first-line osteoarthritis treatment was superior to routine self-managed usual care and could (continued) Key Points QuestionWhat is the effectiveness of an internet-based exercise program vs routine self-management on pain outcomes among patients with knee osteoarthritis? FindingsThis randomized clinical trial including 105 patients compared an internet-based program, including recommended information and exercises, with usual care for patients with knee osteoarthritis. Patients receiving the internet-based program experienced decreased pain and improved function at 6 weeks vs the usual care group. MeaningThese finding suggest that digitally delivered treatment information provided an important patient benefit and may decrease the burden of treatment for knee osteoarthritis on both patients and health care systems. + Visual Abstract + Supplemental content Author affiliations and article information are listed at the end of this article. Open Access.This is an open access article distributed under the terms of the CC-BY License. JAMA Network Open.2021;4(2):e210012. doi:10.1001/jamanetworkopen.2021.0012(Reprinted)February 23, 2021 1/15Downloaded From: https://jamanetwork.com/ on 07/26/2021 Abstract (continued) be provided without harm to people with osteoarthritis. Effect sizes observed in the intervention group corresponded to clinically important improvements. TRIAL REGISTRATIONClinicalTrials.gov Identifier:NCT03545048 JAMA Network Open.2021;4(2):e210012. Corrected on March 25, 2021. doi:10.1001/jamanetworkopen.2021.0012 Introduction Osteoarthritis is the most common joint disease and among the most prevalent chronic conditions. 1 It causes pain and disability in adult and elderly populations, representing a heavy burden on health care systems and society. In the United Kingdom, as in rest of the Western world, 10% to 15% of adults consult their general practitioners about osteoarthritis every year. 1-4The UK National Institute for Health and Care Excellence (NICE) recommends that the first-line treatment for knee osteoarthritis should include disease information and a long-term exercise program. 5 Long-term treatment in chronic diseases is not compatible with the need for cutting health care spending or for reducing face-to-face consultations during the ongoing coronavirus disease 2019 (COVID-19) pandemic. Therefore, internet-based remote treatment may be an efficacious and cost- effective alternative compared with routine in-person treatment. 6The advantages of internet- delivered health care in user flexibility and the ability to receive care at home (thus avoiding travel) have prompted the development of an internet-based first-line osteoarthritis management program consisting of exercises, informational lessons, an asynchronous dialogue with a physiotherapist, and outcome monitoring. A 2017 observational study 7reported improved physical function and decreased pain levels at 6 weeks among patients receiving an internet-based exercise program, and these improvements were confirmed at the 48-week follow-up. 8Additionally, some studies have shown that participants who took part in the 6-week digital program changed their mind regarding undergoing surgical treatment and expressed support for digital osteoarthritis treatment. 9-11 However, no randomized clinical trials have compared this digital program with usual care. Previous studies using online interventions suggest that there is a lack of high-quality studies without methodological flaws (eTable 1 inSupplement 1); hence, there is a need for a randomized clinical trial assessing a digital intervention for knee osteoarthritis vs usual care. The aim of this study was to determine the efficacy of a 6-week internet-based exercise intervention 7to modulate pain, muscle strength, and function in individuals with knee osteoarthritis compared with self-managed usual care. Methods This randomized clinical trial was approved by the sponsors and performed according to the Declaration of Helsinki. 12The study received approval from the Research Ethics Committee of Nottingham University, Health Research Authority, and the Nottingham University Hospitals National Health Service Trust Research and Innovation department. All participants provided written informed consent. This study is reported following the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline. Trial Design The Internet-Based Exercise Programme Aimed at Treating Knee Osteoarthritis (iBEAT-OA) is a parallel-group randomized clinical trial, performed in the primary care setting and managed from Nottingham City Hospital, Nottingham, United Kingdom, in participants with knee osteoarthritis, JAMA Network Open |Orthopedics Effectiveness of Internet-Based Exercises Aimed at Treating Knee Osteoarthritis JAMA Network Open.2021;4(2):e210012. doi:10.1001/jamanetworkopen.2021.0012(Reprinted)February 23, 2021 2/15Downloaded From: https://jamanetwork.com/ on 07/26/2021 comparing a digitally delivered intervention with usual care self-management randomized in a 1-to-1 ratio. The trial protocol has been published elsewhere 13and can be found inSupplement 2. Participants Participants were recruited from an existing database of community-dwelling adults with knee pain who had previously agreed to be contacted for future studies on osteoarthritis or from answering advertisements posted on social media. Inclusion criteria were age 45 years or older, a clinical diagnosis of knee osteoarthritis (defined as knee pain for3 months, early morning stiffness 50 146Randomized 79Allocated to control group 74 5Received allocated intervention Did not receive allocated intervention (did not attend baseline appointment)67Allocated to intervention group 63 4Received allocated intervention Did not receive allocated intervention (did not attend baseline appointment) 17Lost to follow-up 2 1 14Gave no reason Experienced dizziness Lost owing to COVID-1915Lost to follow-up 1 1 13Had family commitments Experienced increased low back pain (patient had chronic low back pain) Lost owing to COVID-19 57Analyzed48Analyzed BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared); COVID-19, coronavirus disease 2019. JAMA Network Open |Orthopedics Effectiveness of Internet-Based Exercises Aimed at Treating Knee Osteoarthritis JAMA Network Open.2021;4(2):e210012. doi:10.1001/jamanetworkopen.2021.0012(Reprinted)February 23, 2021 6/15Downloaded From: https://jamanetwork.com/ on 07/26/2021 Baseline Data The mean baseline demographic and clinical variables were similar for participants in both groups (Table 1). The mean baseline demographic and clinical variables for 17 participants in the control group and 15 participants in the intervention group who could not finish follow-up session were similar to the participants who completed both sessions (Table 1). Owing to COVID-19 lockdown restrictions, baseline data for WOMAC and MSK-HQ for these 32 participants were not retrieved for analysis. Primary Outcome The intervention group showed a greater decrease in NRS pain score from baseline to 6 weeks compared with the control group (between-group difference, −1.5 [95% CI, −2.2 to −0.8];P< .001) (Table 2;Figure 2). Between baseline and the 6-week follow-up, there was a statistically significant improvement in NRS pain scores in the intervention group (mean change, −1.8 [95% CI, −2.4 to −1.3]; d= −0.83) but not in the usual care group (mean change, −0.3 [95% CI, −0.8 to 0.2];d= −0.2) (Figure 2). Table 1. Participant Baseline Characteristics CharacteristicParticipants, mean (SD) Usual care (n = 57)Intervention (n = 48)Withdrew a Usual care (n = 17)Intervention (n = 15) Age, y 68.0 (8.6) 65.2 (9.7) 64 (8) 64 (5) Sex, No (%) Women 37 (64.9) 34 (70.8) 11 (64.7) 11 (73.3) Men 20 (35.1) 14 (29.2) 6 (35.3) 4 (26.7) BMI 31.9 (5.9) 30.4 (5.5) 28.7 (4.6) 30.5 (4.9) Radiographic Score, No. (%) 14,15 2.1 2.0 1.9 1.9 1 18 (31.6) 19 (39.6) 6 (35.3) 5 (33.3) 2 22 (38.6) 13 (27.1) 8 (47.1) 7 (46.7) 3 11 (19.3) 11 (22.9) 2 (11.8) 2 (13.3) 4 6 (10.5) 5 (10.4) 1 (5.9) 1 (6.7) NRS pain b 4.7 (2.1) 4.4 (2.0) 4.3 (1.5) 4.3 (1.6) WOMAC c Pain 7.8 (3.7) 8.0 (3.9) NA NA Stiffness 3.1 (1.6) 4.0 (1.7) NA NA Physical function 28.3 (12.8) 26.8 (12.9) NA NA TUG, s d 9.9 (3.6) 9.0 (1.4) 9.1 (2.5) 9.4 (1.9) 30-s sit-to-stands, No. e 9.2 (4.3) 9.3 (2.7) 10.1 (1.7) 9.8 (1.9) MSK-HQ f 28.4 (10.1) 30.7 (9.9) NA NA PPT Superolateral patella 317.3 (170.2) 314.4 (153.7) 350.1 (84.8) 315.6 (150.7) Superomedial patella 334.1 (147.4) 326.0 (149.9) 370.5 (131.7) 305.4 (103.8) Medial joint line 355.1 (202.5) 318.7 (159.0) 359.7 (173.0) 319.0 (105.4) Tibialis anterior muscle 367.0 (182.4) 386.40 (175.8) 372.8 (150.2) 373.0 (122.8) Temporal summation 1.8 (1.8) 2.30 (1.8) 1.9 (1.1) 2.2 (1.7) Conditional pain modulation 52.8 (110.7) 53.4 (97.6) 41.0 (130.4) 77.5 (100.5) Isokinetic peak torque, Nm g Quadriceps 60°/s 69.4 (42.7) 79.52 (45.6) 77.7 (29.8) 80.1 (37.7) Hamstring 60°/s 52.19 (26.7) 54.44 (29.6) 60.5 (23.0) 63.3 (25.3) Quadriceps 180°/s 40.7 (26.1) 46.10 (28.8) 53.1 (24.0) 49.7 (22.1) Hamstring 180°/s 37.3 (21.2) 40.8 (22.5) 47.9 (13.3) 45.2 (14.2)Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); MSK-HQ, Musculoskeletal Health Questionnaire; NA, not applicable; NRS, numerical rating scale; PPT, pressure pain threshold; TUG, Timed Up-and-Go test; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index. aIncludes participants who dropped out or who were unable to have a second assessment after 6-weeks because of the UK lockdown on March 23, 2020. bRange, 0 to 10, with 0 indicating no pain and 10, the worst pain imaginable. cRange, 0-4, with lower scores indicating lower levels of pain (5 items; range, 0-20), stiffness (2 items; range, 0-8), and physical function (17 items; range, 0-68). dMeasured in seconds, the participant stands up at therapist’s command, walks 3 m, turns around, walks back to the chair and sits down. eCounts the number of times the participant comes from a sitting position on a chair to a full standing position in 30 seconds. fScored on a scale of 0 to 4, with lower scores indicating lower levels of symptoms or physical disability; the total score is the sum of all items. gThe isokinetic peak torque (Newton meter) of quadriceps and hamstring muscles measured at 60°/s and at 180°/s. JAMA Network Open |Orthopedics Effectiveness of Internet-Based Exercises Aimed at Treating Knee Osteoarthritis JAMA Network Open.2021;4(2):e210012. doi:10.1001/jamanetworkopen.2021.0012(Reprinted)February 23, 2021 7/15Downloaded From: https://jamanetwork.com/ on 07/26/2021 Secondary Outcomes The between-group analysis of mean change from baseline to 6 weeks showed that the intervention group improved statistically significantly more than the control group in the WOMAC subscales for pain (between-group difference, −1.1 [95% CI, −2.0 to −0.2];P= .02), stiffness (between-group difference, −1.0 [95% CI, −1.5 to −0.5];P< .001) and physical function (between-group difference, Table 2. Change in Primary and Secondary Outcomes OutcomeUsual care group Intervention group Between-group difference in change, mean (95% CI) a Pvalue Change, mean (95% CI) Cohend, change Change, mean (95% CI) Cohend, change NRS pain b −0.3 (−0.8 to 0.2) −0.20 −1.8 (−2.4 to −1.3) −0.83 −1.5 (−2.2 to 0.8)