Osteoarthritis, Knee
Conditions
Brief summary
The purpose of the study is to evaluate the superiority of Rebel Reliever® knee brace + standard treatment versus standard treatment alone in terms of last 24-hour pain relief after 6 weeks. in patients with medial knee osteoarthritis.
Detailed description
The main criteria is the evaluation of global knee pain during the last 24 hours at D 49 after the inclusion. The response to the treatment will be evaluated during the inclusion visit (V1/D0) and after 6 weeks of treatment, during the following visit (V3/D49). The level of the global pain of the patient during the last 24 hours will be collected by investigators with a VAS (0 mm = no pain ; 100mm = maximun pain) at each visit.
Interventions
DEVICERebel Reliever
Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations
OTHERControl
Usual antalgic treatment + physical exercises recommendations
Sponsors
Thuasne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Male or female over 18 years * BMI \< or egal to 35kg/m2 * symptomatic gonarthrose defined by a recurrent pain to the walk on 30 days during the last 2 months before the inclusion with radiological findings (grade II to IV on Kellgren-Lawrence) * diagnosis of medial femoro-tibial knee osteoarthrosis * patient with global pain intensity during the last 24hours \> or egal 40 mm (EVA) at the day of selection Main
Exclusion criteria
* femoro-patellar predominant arthrosis * septic arthritis * metabolic arthropathies * chronical rheumatismal diseases * other knee diseases * symptomatic coxarthrosis * controlateral gonathrosis with corticoids injections * any other serious disease which may interfere with the results * psychiatrics disorders * skin lesions or dermal pathologies * venous or arterial disorders * sensitivity disorders in the lower limbs (diabetes mellitus..) * paracetamol intolerance * hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion * on going knee viscosupplementation at inclusion * slow acting OA drugs (if started in the last 2 months prior to inclusion) * opioids, corticosteroids, or NSAIDs intake in the last 48 hours prior to inclusion * pregnant women of with no contraception * hepatic or renal insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution of the last 24 hours knee pain (VAS) | Between Day 49 and Day 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of knee pain on movement (VAS) | Between Day 49 and Day 0 | Evaluation with Visual Analysis Scale |
| Evolution of Lequesne Algofunctional index score | Between D49 and Day 0 | — |
| Responder rate according to OARSI-OMERACT criteria | At Day 49 | — |
Other
| Measure | Time frame |
|---|---|
| Percentage of patients with at least one adverse event or serious adverse event in each groups. | during the 6 weeks of brace wearing |
Countries
France
Outcome results
None listed