Knee Pain, Osteoarthritis
Conditions
Brief summary
The study evaluated the efficacy of combined mechanical vibrations, continuous passive motion and heat on the severity of pain in management of osteoarthritis of the knee
Interventions
DEVICEKineticure System followed by sham
20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion) during the first 4 weeks followed by 2 weeks wash out and 4 weeks of sham device
DEVICEsham followed by Kineticure System
sham device during the first 4 weeks then 2 weeks wash out period followed by 4 weeks for 20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion)
Sponsors
Kineticure
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of OA of the knee by ACR criteria * symptoms consistent with radiographic OA grades 2, 3 or 4 by Kellgren and Lawrence criteria * moderate to severe knee pain (≥35mm on a 100mm visual analog pain scale (VAS)).
Exclusion criteria
* knee or hip surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intensity of pain as measured on a 100 mm non-marked VAS and the total Western Ontario McMaster (WOMAC) OA index using a Likert scale, | 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| satisfaction of use of the Kineticure device as measured on a 0-100 mm non-marked scale | 10 weeks |
| range of motion (ROM) of the knee (using goniometer) | 10 weeks |
Countries
United States
Outcome results
None listed