A double blind, randomised, sham-controlled trial investigating the effects of combining electrical stimulation of the calf and thigh muscles in patients with osteoarthritis of the knee
Osteoarthritis of the knee
Participants are randomised by a computer-generated system to one of two groups: 1. Revitive device 2. Sham device This will be a blinded study, therefore, participants will not know which device they will receive until the end of the study. The assessor will also be unaware of this. The Revitive device is an electrical stimulation device comprising of a foot plate and gel pad electrodes. Muscular contraction is stimulated in the calf through the footplate and in the quadriceps by placing the gel pads on the skin. The intensity of stimulation is controlled through a remote by the participant. The sham device will be identical including the remote control, although the device will provide insufficient stimulation to achieve muscular contraction. The participants will require three visits to the hospital in total. The first visit will provide further information for the study, obtain consent, provide activity tracker and collect medical and demographic details. On the second visit participants will perform strength testing, functional tests and questionnaires. They will also be randomized to the device or sham device on the second visit, this will be performed by another researcher through sealedenvelopes.com. The footplate will be used daily for 30 minutes. The quadriceps electrodes will be used 5 times a week for 20 minutes. A participant diary will be kept to log intensity and frequency of use. After 7 weeks the participants will be sent an activity tracker to wear during the final week. After 8 weeks the initial measures will be repeated and this will conclude the visit schedule. Those on the sham treatment will be offered the real device. (added 19/05/2022): 8 weeks after the final study visit participants will be sent the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire through the post to complete.
1. OA diagnosed clinically in accordance with NICE guidance. 2. Aged 45-85 years.
1. Fitted with an electronic implant such as a pacemaker or defibrillator. 2. Pregnant. 3. Existing or undergoing treatment for DVT. 4. Significantly impaired cognitive ability. 5. Inflammatory arthritis. 6. Dermatological conditions affecting the feet or legs. 7. Neurological disorder affecting the feet or legs. 8. Significant osteoarthritis of the hip, ankle or foot. 9. Current or recent knee surgery, trauma or injury (last 3 months). 10. Previous corticosteroid or hyaluronic acid injections (last 6 months). 11. BMI over 40. 12. Use of transcutaneous electrical stimulation. 13. Use of neuromuscular electrical stimulation device.