Reinforcement of Placebo Response in Knee Osteoarthritis: A Randomised Trial

NCT05225480 | Completed

• 1 other identifier: APPI2-OA-2022-01
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Saline intra-articular injections used as placebo treatments have been shown to provide pain relief in knee osteoarthritis (OA) It has further been shown that beneficial effects can be induced merely by having a conversation with a health professional. The aim of this study is to determine whether an individual conversation based on the individual's illness perception related to knee OA affects the response to an intra-articular treatment with saline in individuals with knee OA.

Conditions

Knee Osteoarthritis

Keywords

Illness perception; Knee osteoarthritis; Placebo; Randomized trial

Outcome Measures

Primary Outcomes (1)

• VAS knee pain

  Knee pain defined as "the average level of pain in your knee today" will be assessed with a 100 mm visual analogue scale (VAS) with anchors 0 = "no pain" and 100 = "Worst imaginable pain".

  Week two, change from baseline

Secondary Outcomes (10)

• The effect of knee pain variability (VAS) prior to the intervention

  Week 0, Change from week -1

• Brief Illness perception questionnaire

  Week two, change from baseline

• Knee injury and Osteoarthritis Outcome Score

  Week two, change from baseline

• The 30 seconds sit to stand test

  Week two, end of trial, change from baseline

• 4x10 meter fast walk test

  Week two, change from baseline

Other Outcomes (1)

• Knee joint effusion

  Week two, change from baseline

Study Arms (2)

intervention arm

EXPERIMENTAL

The illness perception conversation will be delivered in one session during around 15 minutes. The conversation will be based on responses to the eight item Brief illness perception questionnaire and a rating of the most relevant item made by the patient on the same day. The aim of the conversation will be to get an overview of the patient's illness perceptions concerning their knee OA and what is deemed the most maladaptive perceptions by the participant. Participants will be invited to elaborate on their thoughts concerning these perceptions.Although any maladaptive perceptions will be corrected if natural during the conversation, the conversation will not lead to any active attempts of changing illness perceptions. Rather, the conversation focusses on giving patients time and opportunity to express knee pain related perceptions and worries concerning their knee pain.

Behavioral: Illness perception conversation

control arm

ACTIVE COMPARATOR

The control conversation will be delivered in one session during around 15 minutes. In order to create two similar conversational settings where the only difference is the actual content of the conversations. The conversation will be based on responses to an eight item questionnaire concerning motivation for research participation and - similar to the illnes perception conversation - a rating of the most relevant item made by the patient. The aim of the conversation will be to get an overview of the patient's motivation for research participation and let them elaborate on their thoughts concerning their motivation.

Behavioral: research motivation conversation

Interventions

Illness perception conversation BEHAVIORAL

A conversation based on the indvidual's knee pain related illness perceptions

intervention arm

research motivation conversation BEHAVIORAL

A conversation based on the indvidual's motivation for participating in research

control arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥50 years
• A clinical diagnosis of tibiofemoral OA in the target knee according to the American College of Rheumatology
• Average knee pain in the last week during weight bearing activities of at least 4 on a 0 to 10 points scale (0=no pain; 10=worst possible pain).

You may not qualify if:

• Not able to speak or understand Danish
• Scheduled surgery during study participation
• History of target knee surgery within 12 months
• History of arthroplasty in the target knee
• Injection therapy in either knee within 3 months
• Current use of oral glucocorticoids
• Current use of synthetic or non-synthetic opioids
• Contraindications to intra-articular injections, such as wounds or skin rash over injection site.
• Planning to start or discontinue other treatment for knee OA in the study participation period
• Inflammatory arthritis, such as rheumatoid arthritis or psoriatic arthritis.
• Regional pain syndromes
• Generalised pain syndromes such as fibromyalgia
• Lumbar or cervical nerve root compression syndromes
• Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as large knee joint effusion, uncontrolled diabetes, psychiatric and/or neurological disorders, or opiate dependency

Sponsors & Collaborators

• Frederiksberg University Hospital: lead
• Department of Psychology and Behavioural Sciences, Aarhus University: collaborator

Study Sites (1)

The Parker Institute, Bispebjerg-Frederiksberg Hospital

Frederiksberg, Danmark, 2000, Denmark

Location

Related Publications (1)

• Ginnerup-Nielsen E, Jorgensen TS, Dew-Hattens C, Christensen R, Berg JI, Vase L, Dossing A, Nielsen SM, Kristensen LE, Bliddal H, Ellegaard K, Henriksen M. The impact of an illness perception conversation on open-label placebo response in knee osteoarthritis: A randomised controlled trial. Osteoarthritis Cartilage. 2024 Dec;32(12):1610-1619. doi: 10.1016/j.joca.2024.07.005. Epub 2024 Jul 17.

  PMID: 39029733 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marius Henriksen, Professor

  the Parker Institute, Bisbebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants are masked as to which intervention (conversation) is considered the actual intervention. Therapists doing physical tests are blinded to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized single blind controlled trial

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 4, 2022
• Study Start: April 21, 2022
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

DK (1)