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

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255835
• Other study ID #: H-20080028
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: September 2023
• Source: Herlev and Gentofte Hospital
• Contact: Mikkel R Andersen, MD, Ph.D.
• Phone: +4538672796
• Email: mikkel.rathsach.andersen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Semiconductor Knee Sleeves
semiconductor elements germanium and carbon within the cotton fabric
• Cotton Knee Sleeves (Placebo)
cotton fabric knee sleeves

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Pain	Visual Analog Scale 0-100, 0-no pain, 100 maximum pain	3 months
Secondary	Knee function	Oxford Knee Score, 0-48, 0-indication of low level of knee function, 48 indication of satisfactory knee function	3 months
Secondary	Knee Range of Motion (ROM)	Range of motion for the knee, extension-flexion- 0-140	3 months
Secondary	Life Quality assessment	SF-36 score, (Short Form Survey-36), 36 life quality items questionaire, 0-lowest score, 100-highest score	3 months