Medial tibiofemoral knee osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
Participants will be in the study for 10 weeks. During this period, they will wear two different knee braces (Unloader One knee brace and novel knee brace) and for two weeks each with a 1-week period
Sponsors
Peacocks Medical Group Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged between 40 and 70 years old having radiological and symptomatic medial knee osteoarthritis (Kellgren-Lawrence grade II, III or IV) according to the American College of Rheumatology’s clinical and radiological criteria (Altman, 1986) 2. Average knee pain > 4/10 (VAS score assessed three times in two weeks before being included) 3. Not currently wearing knee brace 4. Varus knee alignment equal or superior to 2° 5. No or light pain from the hips, ankles, feet or lumbar spine 6. Moderately physically active 7. Able to understand written and spoken English
Exclusion criteria
Exclusion criteria: 1. Mild knee osteoarthritis (Kellgren-Lawrence grade I) 2. Lateral or patellar knee osteoarthritis 3. Chronic diseases or conditions (e.g., diabetes, osteoporosis, heart disease, hypertension, neurological disorders) 4. Stroke history 5. Inflammatory arthritis (gout, rheumatoid arthritis, psoriatic arthritis etc) 6. Musculoskeletal disorders that could influence their ability to stand and walk 7. Morbid obesity (BMI > 35) 8. Intra-articular corticosteroid/hyaluronan injection in the affected knee in the past 3 months 9. Unstable medication schedule and medication that causes dizziness 10. Severe recent modification of diet 11. Prosthetic implants in the hip, knee or ankle joint 12. Poor skin condition 13. Unable to walk, walk up and down stairs or any condition contraindicating the demands of the gait analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Knee pain before and after each 2-week intervention, measured with 10-cm visual analog scale after each condition of laboratory assessment 2. Knee adduction moment before and after each 2-week intervention - peaks and angular impulse from motion capture system | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Knee brace comfort before and after each 2-week intervention, measured with 10-cm visual analog scale after each condition of laboratory assessment 2. Stability feelings before and after each 2-week intervention, measured with 10-cm visual analog scale after each condition of laboratory assessment 3. Symptoms and quality of life before and after each 2-week intervention, measured with KOOS and MOS SF-36 questionnaires subscales 4. Amount of daily physical activities during the second week of each intervention period - four components of physical activity considered by the World Health Organization (WHO) - Frequency, Intensity, Time and Type (FITT) - measured with an activity monitor. We are particularly interested in daily activities and intensities 5. Knee flexion moment before and after each 2-week intervention - peak from motion capture system 6. Lower limb symmetry before and after each 2-week intervention - duration of phases in seconds and percentage, step width and length measured by gait analysis 7. Knee range of motion before and after each 2-week intervention - knee flexion/extension, adduction/abduction, internal/external rotation angles measured by gait analysis | — |
Countries
United Kingdom
Outcome results
None listed