Trials / Completed
CompletedNCT05225480
Reinforcement of Placebo Response in Knee Osteoarthritis: A Randomised Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- Frederiksberg University Hospital · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Illness perception conversation | A conversation based on the indvidual's knee pain related illness perceptions |
| BEHAVIORAL | research motivation conversation | A conversation based on the indvidual's motivation for participating in research |
Timeline
- Start date
- 2022-04-21
- Primary completion
- 2023-02-23
- Completion
- 2023-02-23
- First posted
- 2022-02-04
- Last updated
- 2023-06-01
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05225480. Inclusion in this directory is not an endorsement.