Exercise and education vs intra-articular saline for knee osteoarthritis: a 1-year follow-up of a randomized trial

M Henriksen; R Christensen; L E Kristensen; H Bliddal; C Bartholdy; M Boesen; K Ellegaard; J Guldberg-Møller; D J Hunter; R Altman; E Bandak

doi:10.1016/j.joca.2022.12.011

Exercise and education vs intra-articular saline for knee osteoarthritis: a 1-year follow-up of a randomized trial

Osteoarthritis Cartilage. 2023 May;31(5):627-635. doi: 10.1016/j.joca.2022.12.011. Epub 2023 Jan 16.

Authors

M Henriksen¹, R Christensen², L E Kristensen³, H Bliddal³, C Bartholdy³, M Boesen³, K Ellegaard³, J Guldberg-Møller³, D J Hunter⁴, R Altman⁵, E Bandak³

Affiliations

¹ The Parker Institute, Copenhagen University Hospital - Bispebjerg Frederiksberg, Denmark. Electronic address: marius.henriksen@regionh.dk.
² The Parker Institute, Copenhagen University Hospital - Bispebjerg Frederiksberg, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark.
³ The Parker Institute, Copenhagen University Hospital - Bispebjerg Frederiksberg, Denmark.
⁴ Sydney Musculoskeletal Health, Kolling Institute of Medical Research, The University of Sydney, Australia; Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia.
⁵ Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA.

PMID: 36657659
DOI: 10.1016/j.joca.2022.12.011

Abstract

Objective: To assess the longer-term effect of the Good Life with osteoarthritis in Denmark (GLAD) exercise and education program relative to open-label placebo (OLP) on changes from baseline in core outcomes in individuals with knee osteoarthritis (OA).

Methods: In this 1-year follow-up of an open-label, randomized trial, patients with symptomatic and radiographically confirmed knee OA were monitored after being randomized to either the 8-week GLAD program or OLP given as 4 intra-articular saline injections over 8 weeks. The primary outcome was the change from baseline in the Knee injury and Osteoarthritis Outcome Score questionnaire (KOOS) pain subscale after 1 year in the intention-to-treat population. Key secondary outcomes were the KOOS function and quality of life subscales, and Patients' Global Assessment of disease impact.

Results: 206 adults were randomly assigned: 102 to GLAD and 104 to OLP, of which only 137 (63/74 GLAD/OLP) provided data at 1 year. At one year the mean changes in KOOS pain were 8.4 for GLAD and 7.0 for OLP (Difference: 1.5 points; 95% CI -2.6 to 5.5). There were no between-group differences in any of the secondary outcomes.

Conclusions: In this 1-year follow-up of individuals with knee OA, the 8-week GLAD program and OLP both provided minor longer-term benefits with no group difference. These results require confirmation given the significant loss to follow-up.

Trial registration number: NCT03843931.

Keywords: Exercise, education; Knee; Long-term; Open-label placebo; Osteoarthritis; Subgroup.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Follow-Up Studies
Humans
Injections, Intra-Articular
Osteoarthritis, Knee*
Pain / drug therapy
Quality of Life
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT03843931