Status:
COMPLETED
Saline Injections vs Education and Exercise in Knee Osteoarthritis
Lead Sponsor:
Marius Henriksen
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Knee osteoarthritis (OA) is a highly prevalent musculoskeletal condition mainly affecting older people, causing pain, physical disability, and reduced quality of life. Exercise and patient education a...
Eligibility Criteria
Inclusion
- Age ≥50 years.
- Body Mass index ≤ 35
- A clinical diagnosis of tibiofemoral OA in the target knee according to the American College of Rheumatology (12).
- 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).
- Verification of clinical diagnosis by definite tibiofemoral OA on posterior-anterior weight bearing semi-flexed knee radiographs with severity equivalent to Kellgren and Lawrence grade 2 or more.
Exclusion
- Intra-articular treatments of any kind of either knee 3 months before inclusion
- Scheduled surgery during study participation
- Knee joint fluid aspiration within 3 month of baseline visit
- Participation in exercise therapy within 3 months of baseline visit
- Evidence of other inflammatory joint disease (e.g. rheumatoid arthritis or gout)
- History of knee surgery within 12 months
- History of arthroplasty in the target knee
- Use of oral glucocorticoids
- Use of synthetic or non-synthetic opioids
- Other musculoskeletal, neurological, medical conditions precluding participation in exercise
- Contraindications to intra-articular injections, such as wounds or skin rash over injection site.
- Contraindications to exercise
- Planning to start other treatment for knee OA in the study participation period
- 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 disorders, or opiate dependency.
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2020
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT03843931
Start Date
August 5 2019
End Date
December 18 2020
Last Update
December 22 2020
Active Locations (1)
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1
The Parker Institute, Frederiksberg Hospital
Copenhagen, Denmark, 2000