Saline injections versus Education and Exercise in knee osteoarthritis
- Conditions
- Knee osteoarthritisMedDRA version: 20.0Level: LLTClassification code 10031165Term: Osteoarthritis kneeSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2019-000809-71-DK
- Lead Sponsor
- The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
- Age =50 years.
- Body Mass index = 35
- 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).
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- 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
- Pregnancy or insufficient anti-conception therapy for female fertile patients
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare a widely used education plus exercise program (the GLA:D<br>program) with intra-articular saline injections as treatments of knee OA<br>symptoms;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is change from baseline in the Knee injury and<br>Osteoarthritis Outcome Score (KOOS) pain subscale.;Timepoint(s) of evaluation of this end point: After 9 weeks
- Secondary Outcome Measures
Name Time Method