The impact of an illness perception conversation on open-label placebo response in knee osteoarthritis: A randomised controlled trial

Elisabeth Ginnerup-Nielsen; Tanja Schjødt Jørgensen; Camilla Dew-Hattens; Robin Christensen; Johannes Iuel Berg; Lene Vase; Anna Døssing; Sabrina Mai Nielsen; Lars Erik Kristensen; Henning Bliddal; Karen Ellegaard; Marius Henriksen

doi:10.1016/j.joca.2024.07.005

The impact of an illness perception conversation on open-label placebo response in knee osteoarthritis: A randomised controlled trial

Elisabeth Ginnerup-Nielsen^*
, Tanja Schjødt Jørgensen
, Camilla Dew-Hattens
, Robin Christensen
, Johannes Iuel Berg
, Lene Vase
, Anna Døssing
, Sabrina Mai Nielsen
, Lars Erik Kristensen
, Henning Bliddal
, Karen Ellegaard
, Marius Henriksen

^*Corresponding author af dette arbejde

Psykologisk Institut

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

1 Citationer (Scopus)

Abstract

Objective: To compare the effect of an illness perception conversation (IPC), relative to a research participation conversation (RPC), on 2-week changes in knee pain in patients with knee osteoarthritis. Method: This was a randomised single-blind trial. Patients were randomised to two matched conversations. An IP conversation concerning the participant's knee pain-related illness perception (IP) or an RPC concerning the participant's motivation for participating in research. Both conversations were followed by an open-label intraarticular saline injection in the most symptomatic knee. The primary outcome was change in knee pain from baseline to 2 weeks follow-up on a 100 mm visual analogue scale (VAS). Key secondary outcomes included the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales: Activities of daily living (ADL) and Quality of life (QoL). Main analyses were based on the intention-to-treat population using repeated measures mixed effects linear models. Results: 103 patients were randomised to the IPC group (n = 52) and the RPC group (n = 51). VAS knee pain scores changed statistically significantly from baseline to end of treatment in both groups, −13.7 (standard error [SE]: 3.2) in the IPC group and −13.0 (SE: 3.1) in the RPC group with an adjusted between-group difference of −0.7 (95% CI: −8.3 to 6.9; P = 0.85). Likewise, no group differences were seen in KOOS ADL and KOOS QoL. Conclusion: A conversation concerning knee pain-related IP did not augment the pain-relieving effect of an open-label placebo injection when compared to a similar control conversation concerning motivations for participating in research. Trial registration: NCT05225480.

Originalsprog	Engelsk
Tidsskrift	Osteoarthritis and Cartilage
Vol/bind	32
Nummer	12
Sider (fra-til)	1610-1619
Antal sider	10
ISSN	1063-4584
DOI	https://doi.org/10.1016/j.joca.2024.07.005
Status	Udgivet - dec. 2024

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10.1016/j.joca.2024.07.005Licens: CC BY

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Ginnerup-Nielsen, E., Jørgensen, T. S., Dew-Hattens, C., Christensen, R., Berg, J. I., Vase, L., Døssing, A., Nielsen, S. M., Kristensen, L. E., Bliddal, H., Ellegaard, K., & Henriksen, M. (2024). The impact of an illness perception conversation on open-label placebo response in knee osteoarthritis: A randomised controlled trial. Osteoarthritis and Cartilage, 32(12), 1610-1619. https://doi.org/10.1016/j.joca.2024.07.005

@article{f67ad79cd0af418e8f9bca4913b883f0,

title = "The impact of an illness perception conversation on open-label placebo response in knee osteoarthritis: A randomised controlled trial",

abstract = "Objective: To compare the effect of an illness perception conversation (IPC), relative to a research participation conversation (RPC), on 2-week changes in knee pain in patients with knee osteoarthritis. Method: This was a randomised single-blind trial. Patients were randomised to two matched conversations. An IP conversation concerning the participant's knee pain-related illness perception (IP) or an RPC concerning the participant's motivation for participating in research. Both conversations were followed by an open-label intraarticular saline injection in the most symptomatic knee. The primary outcome was change in knee pain from baseline to 2 weeks follow-up on a 100 mm visual analogue scale (VAS). Key secondary outcomes included the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales: Activities of daily living (ADL) and Quality of life (QoL). Main analyses were based on the intention-to-treat population using repeated measures mixed effects linear models. Results: 103 patients were randomised to the IPC group (n = 52) and the RPC group (n = 51). VAS knee pain scores changed statistically significantly from baseline to end of treatment in both groups, −13.7 (standard error [SE]: 3.2) in the IPC group and −13.0 (SE: 3.1) in the RPC group with an adjusted between-group difference of −0.7 (95\% CI: −8.3 to 6.9; P = 0.85). Likewise, no group differences were seen in KOOS ADL and KOOS QoL. Conclusion: A conversation concerning knee pain-related IP did not augment the pain-relieving effect of an open-label placebo injection when compared to a similar control conversation concerning motivations for participating in research. Trial registration: NCT05225480.",

keywords = "Illness perception, Knee osteoarthritis, Open-label placebo, Randomised controlled trial",

author = "Elisabeth Ginnerup-Nielsen and J{\o}rgensen, \{Tanja Schj{\o}dt\} and Camilla Dew-Hattens and Robin Christensen and Berg, \{Johannes Iuel\} and Lene Vase and Anna D{\o}ssing and Nielsen, \{Sabrina Mai\} and Kristensen, \{Lars Erik\} and Henning Bliddal and Karen Ellegaard and Marius Henriksen",

note = "Publisher Copyright: {\textcopyright} 2024 The Authors",

year = "2024",

month = dec,

doi = "10.1016/j.joca.2024.07.005",

language = "English",

volume = "32",

pages = "1610--1619",

journal = "Osteoarthritis and Cartilage",

issn = "1063-4584",

publisher = "W.B. Saunders Ltd",

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Ginnerup-Nielsen, E, Jørgensen, TS, Dew-Hattens, C, Christensen, R, Berg, JI, Vase, L, Døssing, A, Nielsen, SM, Kristensen, LE, Bliddal, H, Ellegaard, K & Henriksen, M 2024, 'The impact of an illness perception conversation on open-label placebo response in knee osteoarthritis: A randomised controlled trial', Osteoarthritis and Cartilage, bind 32, nr. 12, s. 1610-1619. https://doi.org/10.1016/j.joca.2024.07.005

The impact of an illness perception conversation on open-label placebo response in knee osteoarthritis: A randomised controlled trial. / Ginnerup-Nielsen, Elisabeth; Jørgensen, Tanja Schjødt; Dew-Hattens, Camilla et al.
I: Osteoarthritis and Cartilage, Bind 32, Nr. 12, 12.2024, s. 1610-1619.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

TY - JOUR

T1 - The impact of an illness perception conversation on open-label placebo response in knee osteoarthritis

T2 - A randomised controlled trial

AU - Ginnerup-Nielsen, Elisabeth

AU - Jørgensen, Tanja Schjødt

AU - Dew-Hattens, Camilla

AU - Christensen, Robin

AU - Berg, Johannes Iuel

AU - Vase, Lene

AU - Døssing, Anna

AU - Nielsen, Sabrina Mai

AU - Kristensen, Lars Erik

AU - Bliddal, Henning

AU - Ellegaard, Karen

AU - Henriksen, Marius

PY - 2024/12

Y1 - 2024/12

N2 - Objective: To compare the effect of an illness perception conversation (IPC), relative to a research participation conversation (RPC), on 2-week changes in knee pain in patients with knee osteoarthritis. Method: This was a randomised single-blind trial. Patients were randomised to two matched conversations. An IP conversation concerning the participant's knee pain-related illness perception (IP) or an RPC concerning the participant's motivation for participating in research. Both conversations were followed by an open-label intraarticular saline injection in the most symptomatic knee. The primary outcome was change in knee pain from baseline to 2 weeks follow-up on a 100 mm visual analogue scale (VAS). Key secondary outcomes included the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales: Activities of daily living (ADL) and Quality of life (QoL). Main analyses were based on the intention-to-treat population using repeated measures mixed effects linear models. Results: 103 patients were randomised to the IPC group (n = 52) and the RPC group (n = 51). VAS knee pain scores changed statistically significantly from baseline to end of treatment in both groups, −13.7 (standard error [SE]: 3.2) in the IPC group and −13.0 (SE: 3.1) in the RPC group with an adjusted between-group difference of −0.7 (95% CI: −8.3 to 6.9; P = 0.85). Likewise, no group differences were seen in KOOS ADL and KOOS QoL. Conclusion: A conversation concerning knee pain-related IP did not augment the pain-relieving effect of an open-label placebo injection when compared to a similar control conversation concerning motivations for participating in research. Trial registration: NCT05225480.

AB - Objective: To compare the effect of an illness perception conversation (IPC), relative to a research participation conversation (RPC), on 2-week changes in knee pain in patients with knee osteoarthritis. Method: This was a randomised single-blind trial. Patients were randomised to two matched conversations. An IP conversation concerning the participant's knee pain-related illness perception (IP) or an RPC concerning the participant's motivation for participating in research. Both conversations were followed by an open-label intraarticular saline injection in the most symptomatic knee. The primary outcome was change in knee pain from baseline to 2 weeks follow-up on a 100 mm visual analogue scale (VAS). Key secondary outcomes included the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales: Activities of daily living (ADL) and Quality of life (QoL). Main analyses were based on the intention-to-treat population using repeated measures mixed effects linear models. Results: 103 patients were randomised to the IPC group (n = 52) and the RPC group (n = 51). VAS knee pain scores changed statistically significantly from baseline to end of treatment in both groups, −13.7 (standard error [SE]: 3.2) in the IPC group and −13.0 (SE: 3.1) in the RPC group with an adjusted between-group difference of −0.7 (95% CI: −8.3 to 6.9; P = 0.85). Likewise, no group differences were seen in KOOS ADL and KOOS QoL. Conclusion: A conversation concerning knee pain-related IP did not augment the pain-relieving effect of an open-label placebo injection when compared to a similar control conversation concerning motivations for participating in research. Trial registration: NCT05225480.

KW - Illness perception

KW - Knee osteoarthritis

KW - Open-label placebo

KW - Randomised controlled trial

UR - https://www.scopus.com/pages/publications/85199350982

U2 - 10.1016/j.joca.2024.07.005

DO - 10.1016/j.joca.2024.07.005

M3 - Journal article

C2 - 39029733

AN - SCOPUS:85199350982

SN - 1063-4584

VL - 32

SP - 1610

EP - 1619

JO - Osteoarthritis and Cartilage

JF - Osteoarthritis and Cartilage

IS - 12

ER -

The impact of an illness perception conversation on open-label placebo response in knee osteoarthritis: A randomised controlled trial

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