Status:
COMPLETED
Reinforcement of Placebo Response in Knee Osteoarthritis: A Randomised Trial
Lead Sponsor:
Frederiksberg University Hospital
Collaborating Sponsors:
Department of Psychology and Behavioural Sciences, Aarhus University
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
50+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT05225480
Start Date
April 21 2022
End Date
February 23 2023
Last Update
June 1 2023
Active Locations (1)
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1
The Parker Institute, Bispebjerg-Frederiksberg Hospital
Frederiksberg, Danmark, Denmark, 2000