Clinical trial NCT05225480: Reinforcement of Placebo Response in Knee Osteoarthritis: A Randomised Trial
Official title: Reinforcement of Placebo Response in Knee Osteoarthritis: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Illness perception
Knee osteoarthritis
Placebo
Randomized trial
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
Collaborators: name: Department of Psychology and Behavioural Sciences, Aarhus University
First posted: 2022-02-04
Enrollment: 103
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized single blind controlled trial
Primary purpose: TREATMENT

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.

Detailed description: Despite many years of research, there is still considerable uncertainty on what causes placebo effects and how these are mediated. Saline is a pharmacologically inert agent frequently used as placebo comparator in clinical trials of intra-articular (IA) treatments for knee osteoarthritis (OA) and patients often experience a significant pain improvement from this treatment even when it is administered as an open label placebo treatment.

It has further been shown that beneficial effects can be induced merely by having a conversation with a health professional and several studies have found the alliance between therapist and patient to have a positive effect on treatment outcome in physical rehabilitation indicating that positive attention by itself leads to beneficial treatment outcomes. Still it is unclear wether the effect of an open label placebo treatment can be influenced by a conversation and if the extent of this infleuence depends on the focus of the conversation.

The aim of this study is to determine whether a conversation about the individual's illness perception related to knee OA affects the response to a placebo treatment (saline injection) in individuals with knee OA.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: VAS knee pain
timeFrame: Week two, change from baseline
Secondary outcomes:
measure: The effect of knee pain variability (VAS) prior to the intervention
timeFrame: Week 0, Change from week -1
measure: Brief Illness perception questionnaire
timeFrame: Week two, change from baseline
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: Week two, change from baseline
measure: The 30 seconds sit to stand test
timeFrame: Week two, end of trial, change from baseline
measure: 4x10 meter fast walk test
timeFrame: Week two, change from baseline
measure: Stair climbing test
timeFrame: Week two, change from baseline
measure: Expectations for Treatment Scale (ETS)
timeFrame: Week 0, change from week -1
measure: Synovial hypertrophy score
timeFrame: Week two, change from baseline
measure: Doppler activity score
timeFrame: Week two, change from baseline
measure: Self-reported paracetamol and ibuprofen use for knee pain
timeFrame: Week two, change from baseline
Other outcomes:
measure: Knee joint effusion
timeFrame: Week two, change from baseline
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Institute, Bispebjerg-Frederiksberg Hospital
state: Danmark
Study officials:
affiliation: the Parker Institute, Bisbebjerg and Frederiksberg Hospital
name: Marius Henriksen, Professor
role: PRINCIPAL_INVESTIGATOR
References: