None listed
Conditions
Brief summary
The primary purpose of this study is to determine whether PES is an effective treatment choice for people with osteoarthritis of the knee. The hypothesis is that PES will produce a clinically important and sustained improvement in pain, function, patient global assessment, quality of life and physical activity when compared with placebo treatment in individuals with osteoarthritis of the knee.
Interventions
A two group double-blind, randomised, placebo-controlled, repeated measures trial will be conducted to investigate the effectiveness of pulsed electrical stimulation (PES) in the management of people with osteoarthritis of the knee over a 26 week period. Subjects in both the intervention and placebo groups will be asked to use the transcutaneously applied PES and placebo-PES respectively at sub-sensory levels for a minimum of seven hours per day (overnight recommended) during the study period. A
A two group double-blind, randomised, placebo-controlled, repeated measures trial will be conducted to investigate the effectiveness of pulsed electrical stimulation (PES) in the management of people with osteoarthritis of the knee over a 26 week period. Subjects in both the intervention and placebo groups will be asked to use the transcutaneously applied PES and placebo-PES respectively at sub-sensory levels for a minimum of seven hours per day (overnight recommended) during the study period. All subjects will be able to continue their usual arthritis management throughout the trial period.
Sponsors
Robyn Fary
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to -2147483648 No limit
Healthy volunteers
No
Inclusion criteria
Primary knee osteoarthritis diagnosed using the American College of Rheumatology modified clinical classification criteria; persistent, stable pain for a minimum of three months; pain score of at least 25mm on a 100mm visual analogue scale
Exclusion criteria
Co-existing inflammatory arthropathies, contraindications to electrical stimulation, existence of skin disorders in the area of the knee to be treated, scheduled to have a knee joint replacement during the study period, unable to read or understand English
Outcome results
None listed