Knee osteoarthritis Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]
Conditions
Interventions
Intervention group:
Subjects assigned to the NMES group will receive specific instruction from a member of the study team on application and logbook recording of the stimulator. The device will be ap
Sponsors
Cappagh National Orthopaedic Hospital (Ireland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 45 - 55 years old 2. Grade 3 - 4 knee arthritis diagnosed arthroscopically 3. Conservatively managed 4. Ambulatory patients
Exclusion criteria
Exclusion criteria: 1. Morbid obesity (body mass index [BMI] greater than 40) 2. Uncontrolled hypertension 3. Anticoagulant therapy 4. Neurological disorder 5. Other lower limb impairment affecting function including amputation 6. Malignancy 7. Inflammatory arthritis 8. Implanted pacemaker or defibrillator 9. Dermatological conditions affecting the thigh 10. Recent participation in an exercise or strength training program 11. Inability to walk unassisted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The Western Ontario McMaster University Arthritis index (WOMAC) is a disease-specific questionnaire that assesses the patient's perception of their own level of mobility. It has been designed for hip or knee osteoarthritis with well-established reliability and validity and consists of 24 questions categorised into pain, stiffness, and physical function and scores range from 1 to 96 (best to worst respectively). WOMAC subscales scores will be transformed to a 0 - 100 scale: 100 - [actual raw score x 100/possible raw score range]. A WOMAC score of 100 indicates that the patient has no problems and a score of 0 indicates that the patient has extreme difficulty. In between, a score of 25 indicates that a patient has severe difficulty, 50 indicates moderate difficulty, and 75 mild difficulty. Differences in WOMAC functional scores of more than 10 points on the transformed 0 - 100 WOMAC scale are generally perceptible to patients. 2. The Medical Outcomes Study 36-item Short Form Health Survey (SF-36) was formed as a culmination of several scales in the Medical Outcomes Study (MOS). It evaluates general health using a 36-item questionnaire under eight parameters: physical and social functioning, role limitations because of emotional problems or physical problems, mental health, bodily pain, vitality, and general health perceptions. Reliability and validity have been established. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional and clinical evaluation: performed at baseline and repeated at week 1, week 3, week 6 and week 12; providing four sets of comparable data (weeks 1, 3, 6, 12): 1.1. Specific measurements of extension lag, flexion deformity, axial alignment (varus/valgus) and thigh girth 1.2. Documented range of motion, including flexion and extension limits both active and passive 1.3. Height and weight measurements, to determine the body mass index (BMI - kg/m^2) 1.4. Physical activity level of each subject, classified into light, moderate or heavy based on the number of hours per day and days per week as follows: 1.4.1. Community active: light exercise x 2 per week 1.4.2. Moderate exercise: greater than or equal to 30 minutes x 3 per week 1.4.3. Heavy exercise: greater than or equal to 30 minutes greater than x 3 per week 2. Performance outcome measures: performed three times with the fastest recorded and used for statistical analysis. Assessments are performed in the same order for each participant at each assessment point. Pain was assessed during each test using a 10-point numeric rating scale (NRS) where 0 represented no pain, and 10 represented the worst pain imaginable. 2.1. 25-metre timed walk test 2.2. Timed Stair-climb Test (TST) 2.3. Up/down Seated Test (Timed Chair Rise) 3. Radiological evaluation 4. Magnetic resonance imaging (MRI): performed to determine quadriceps and hamstring cross-sectional area (CSA) of both thighs using a Gyroscan Intera 1.5T MRI scanner (Philips Medical Systems, Holland, Europe). Scanning to determine CSA will be performed at baseline (week 0) and repeated again after intervention on week 6, and finally at the end of the de-training period (week 12). 5. Quadriceps muscle strength (Torque): a Biodex Multi-joint System 3 dynamometer (Biodex Medical Instruments, Shirley, NY) will be used to determine torque achieved by the quadriceps femoris (QF) muscle of both the involved knee and uninvolved knee. Subjects will attend DCU for bila | — |
Countries
Ireland
Outcome results
None listed