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

Marius Henriksen; Robin Christensen; Lars Erik Kristensen; Henning Bliddal; Cecilie Bartholdy; Mikael Boesen; Karen Ellegaard; Jørgen Guldberg-Møller; David J Hunter; Roy Altman; Elisabeth 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

Marius Henriksen, Robin Christensen, Lars Erik Kristensen, Henning Bliddal, Cecilie Bartholdy, Mikael Boesen, Karen Ellegaard, Jørgen Guldberg-Møller, David J Hunter, Roy Altman, Elisabeth Bandak

20 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	Osteoarthritis and Cartilage
Vol/bind	31
Udgave nummer	5
Sider (fra-til)	627-635
Antal sider	9
ISSN	1063-4584
DOI	https://doi.org/10.1016/j.joca.2022.12.011
Status	Udgivet - maj 2023

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10.1016/j.joca.2022.12.011

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Henriksen, M., Christensen, R., Kristensen, L. E., Bliddal, H., Bartholdy, C., Boesen, M., Ellegaard, K., Guldberg-Møller, J., Hunter, D. J., Altman, R., & Bandak, E. (2023). Exercise and education vs intra-articular saline for knee osteoarthritis: A 1-year follow-up of a randomized trial. Osteoarthritis and Cartilage, 31(5), 627-635. https://doi.org/10.1016/j.joca.2022.12.011

Henriksen, M , Christensen, R , Kristensen, LE , Bliddal, H , Bartholdy, C , Boesen, M , Ellegaard, K , Guldberg-Møller, J, Hunter, DJ, Altman, R & Bandak, E 2023, 'Exercise and education vs intra-articular saline for knee osteoarthritis: A 1-year follow-up of a randomized trial', Osteoarthritis and Cartilage, bind 31, nr. 5, s. 627-635. https://doi.org/10.1016/j.joca.2022.12.011

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

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 = "Adult, Follow-Up Studies, Humans, Injections, Intra-Articular, Osteoarthritis, Knee, Pain/drug therapy, Quality of Life, Treatment Outcome, Knee, Long-term, Subgroup, Exercise, education, Open-label placebo, Osteoarthritis",

author = "Marius Henriksen and Robin Christensen and Kristensen, {Lars Erik} and Henning Bliddal and Cecilie Bartholdy and Mikael Boesen and Karen Ellegaard and J{\o}rgen Guldberg-M{\o}ller and Hunter, {David J} and Roy Altman and Elisabeth Bandak",

year = "2023",

month = may,

doi = "10.1016/j.joca.2022.12.011",

language = "English",

volume = "31",

pages = "627--635",

journal = "Osteoarthritis and Cartilage",

issn = "1063-4584",

publisher = "W.B. Saunders Ltd",

number = "5",

}

TY - JOUR

T1 - Exercise and education vs intra-articular saline for knee osteoarthritis

T2 - A 1-year follow-up of a randomized trial

AU - Henriksen, Marius

AU - Christensen, Robin

AU - Kristensen, Lars Erik

AU - Bliddal, Henning

AU - Bartholdy, Cecilie

AU - Boesen, Mikael

AU - Ellegaard, Karen

AU - Guldberg-Møller, Jørgen

AU - Hunter, David J

AU - Altman, Roy

AU - Bandak, Elisabeth

PY - 2023/5

Y1 - 2023/5

N2 - 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.

AB - 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.

KW - Adult

KW - Follow-Up Studies

KW - Humans

KW - Injections, Intra-Articular

KW - Osteoarthritis, Knee

KW - Pain/drug therapy

KW - Quality of Life

KW - Treatment Outcome

KW - Knee

KW - Long-term

KW - Subgroup

KW - Exercise, education

KW - Open-label placebo

KW - Osteoarthritis

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U2 - 10.1016/j.joca.2022.12.011

DO - 10.1016/j.joca.2022.12.011

M3 - Journal article

C2 - 36657659

SN - 1063-4584

VL - 31

SP - 627

EP - 635

JO - Osteoarthritis and Cartilage

JF - Osteoarthritis and Cartilage

IS - 5

ER -

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

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