Skip to content

The Effect of Semiconductor Knee Sleeves on Pain in Osteoarthritis of the Knee.

A Randomized Prospective Study to Evaluate the Effect of Semiconductor Knee Sleeves on Pain in Osteoarthritis of the Knee.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05255835
Enrollment
50
Registered
2022-02-25
Start date
2022-11-30
Completion date
2026-01-01
Last updated
2023-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteo Arthritis Knee

Keywords

Knee, Arthrosis, Pain, Osteoarthritis, Knee-Sleeves, Semiconductor

Brief summary

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.

Detailed description

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.

Interventions

DEVICESemiconductor Knee Sleeves

semiconductor elements germanium and carbon within the cotton fabric

DEVICECotton Knee Sleeves (Placebo)

cotton fabric knee sleeves

Sponsors

Herlev and Gentofte Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Investigated knee sleeves appear identical, a printed code reveals to investigator if knee sleeves contains semiconductors (intervention group) or are cotton only (placebo group). Participants, care provider and outcome assessors are blinded to intervention/placebo grouping.

Intervention model description

Randomized controlled trial (RCT)

Eligibility

Sex/Gender
ALL
Age
No minimum to 90 Years
Healthy volunteers
No

Inclusion criteria

* Arthrosis of the Knee * Surgery not yet indicated * 40-90 years old * Male or female * Compliant patient * BMI less than 35 * Able to understand Danish sufficiently for written consent

Exclusion criteria

* Rheumatoid Arthritis * Previous blood clots * BMI greater than 35 * Varicosities on operative leg

Design outcomes

Primary

MeasureTime frameDescription
Knee Pain3 monthsVisual Analog Scale 0-100, 0-no pain, 100 maximum pain

Secondary

MeasureTime frameDescription
Knee function3 monthsOxford Knee Score, 0-48, 0-indication of low level of knee function, 48 indication of satisfactory knee function
Knee Range of Motion (ROM)3 monthsRange of motion for the knee, extension-flexion- 0-140
Life Quality assessment3 monthsSF-36 score, (Short Form Survey-36), 36 life quality items questionaire, 0-lowest score, 100-highest score

Countries

Denmark

Contacts

Primary ContactMikkel R Andersen, MD, Ph.D.
mikkel.rathsach.andersen@regionh.dk+4538672796
Backup ContactMathias R Vergmann, Physiotherapuet
mathias.randrup.vergmann@regionh.dk38677456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026