To assess the benefits of using semiconductor (germanium and carbon) woven knee sleeves products in patients with osteoarthritis of the knee. To compare patients in a blinded randomized trial with and without the semiconductor knee sleeves product during the first 3 months period after initial contact at the outpatient clinic. Aims: The hypothesis of the study is that the semiconductor sleeve will reduce pain and improve knee function in active group when compared to the placebo group.
Semiconductor woven knee sleeves work by increasing circulation to reduce inflammation, relieve pain, optimize performance, and accelerate recovery. Unlike compression products, semiconductor knee sleeves do not need to compress to work. Instead, the technology incorporates the semiconductor elements germanium and carbon within the fabric, which when stimulated by body heat, by release of negative ions. The negative ions activate molecular vibrations that increase blood flow and speed. Increasing circulation helps bring more oxygen and nutrients to the target area, which optimizes the body's natural healing process and accelerates recovery. Benefits of Increased Blood Circulation Include: * Accelerated Recovery * Reduced Swelling * Optimized Performance * Reduced Fatigue * Thermoregulation Investigators wish to investigate a possible effect on knee pain and function in patients with osteoarthritis of the knee. Subject Enrollment: Subjects referred with arthrosis of the knee to the out-patient clinic, at the Hip- and Knee-arthroplasty Unit, Herlev Gentofte Hospital. Included subjects must be assessed by an arthroplasty surgeon to have arthrosis without present indication for surgery, and to be eligible for a period of conservative treatment including physiotherapist guided training and paracetamol treatment. This is a prospective study that will require informed consent. Study size calculation A 25% difference in pain reduction between the intervention group compared and the placebo group is considered clinically relevant. Standard deviation expected at 25 mm on a 100 mm visual analog scale (VAS) for pain1. A type II error set at 10%, and a two-sided 5% significance level. A total number of 36 subjects with 18 in each group was calculated. To account for dropouts and the risk of conversion to surgical strategy during the follow-up period we plan to enroll a total of 25 subjects in each group. Study Population: Estimated enrollment Target enrollment - 50 patients * 25 patients with the semiconductor knee sleeve. * 25 patients with the placebo sleeve.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
semiconductor elements germanium and carbon within the cotton fabric
cotton fabric knee sleeves
Gentofte Hospital
Copenhagen, Denmark
RECRUITINGKnee Pain
Visual Analog Scale 0-100, 0-no pain, 100 maximum pain
Time frame: 3 months
Knee function
Oxford Knee Score, 0-48, 0-indication of low level of knee function, 48 indication of satisfactory knee function
Time frame: 3 months
Knee Range of Motion (ROM)
Range of motion for the knee, extension-flexion- 0-140
Time frame: 3 months
Life Quality assessment
SF-36 score, (Short Form Survey-36), 36 life quality items questionaire, 0-lowest score, 100-highest score
Time frame: 3 months
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