Reinforcement of Placebo Response in Knee Osteoarthritis: A Randomised Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2023-02-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cognitive Bias and Heuristics in Patients With Knee Osteoarthritis

NCT05898867

Knee Osteoarthritis

COMPLETED

Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

NCT00144820

Osteoarthritis, Knee

UNKNOWN PHASE4

The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness

NCT04111718

Osteoarthritis, Knee

ACTIVE_NOT_RECRUITING PHASE4

Effect of Reparel Knee Sleeve With Knee Injection

NCT04859764

Osteoarthritis, Knee

COMPLETED NA

Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis

NCT00833157

Osteoarthritis of the Knee

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized single blind controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The participants are masked as to which intervention (conversation) is considered the actual intervention. Therapists doing physical tests are blinded to treatment allocation

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention arm

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.

Group Type EXPERIMENTAL

Illness perception conversation

Intervention Type BEHAVIORAL

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

control arm

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.

Group Type ACTIVE_COMPARATOR

research motivation conversation

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Illness perception conversation

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

Intervention Type BEHAVIORAL

research motivation conversation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No