Exercise and education versus saline injections for knee osteoarthritis: a randomised controlled equivalence trial.

To compare the efficacy of an exercise and education programme with open-label placebo given as intra-articular injections of inert saline on pain and function in individuals with knee osteoarthritis (OA). In this open-label, randomised controlled trial, we recruited adults aged ≥50 years with symptomatic and radiographically confirmed knee OA in Denmark. Participants were randomised 1:1 to undergo an 8-week exercise and education programme or four intra-articular saline injections over 8 weeks. Primary outcome was change from baseline to week 9 in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire pain subscale (range 0 (worst)-100 (best)). Prespecified equivalence margins of ±8 KOOS pain points were chosen for the demonstration of comparable efficacy. Key secondary outcomes were the KOOS function and quality of life subscales, and patients' global assessment of disease impact. 206 adults were randomly assigned: 102 to exercise and education and 104 to intra-articular saline injections. For the primary outcome, the least squares mean changes in KOOS pain were 10.0 for exercise and education and 7.3 for saline injections (difference 2.7 points, 95% CI -0.6 to 6.0; test for equivalence p=0.0008). All group differences in the key secondary outcomes respected the predefined equivalence margins. Adverse events and serious adverse events were similar in the two groups. In individuals with knee OA, an 8-week exercise and education programme provided efficacy for symptomatic and functional improvements equivalent to that of four open-label intra-articular saline injections over 8 weeks. NCT03843931.

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Competing interests: EAB reports grants from The Lundbeck Foundation, The Danish Physiotherapists Association and The Oak Foundation during the conduct of the study; and membership in the Danish Physiotherapist Association. LEK reports receiving fees for speaking and consultancy from Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Janssen pharmaceuticals. JG-M reports personal fees from AbbVie, Eli-Lilly and BK Ultrasound; and grants and personal fees from Novartis outside the submitted work. DJH reports personal fees from Pfizer, Lilly, TLCBio, Novartis, Tissuegene and Biobone outside the submitted work. RA reports personal fees from Novartis, Pfizer and Sorrento; others from Olatec, GSK, Noven, Sanofi and Teva outside the submitted work; and consultancy for GSK, Noven, Novartis, Olatec, Pfizer, Sanofi, Sorrento and Teva. MH reports grants from The Oak Foundation and Aase & Ejnar Danielsens Foundation during the conduct of the study; personal fees from Thuasne Group, outside the submitted work; and membership of Danish Physiotherapist Association.