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.

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.

Study Overview

• Status: Recruiting
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Device: Semiconductor Knee Sleeves; Device: Cotton Knee Sleeves (Placebo)

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mikkel R Andersen, MD, Ph.D.; Phone Number: +4538672796; Email: mikkel.rathsach.andersen@regionh.dk
• Study Contact Backup: Name: Mathias R Vergmann, Physiotherapuet; Phone Number: 38677456; Email: mathias.randrup.vergmann@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2900
    • Recruiting
    • Gentofte Hospital
    • Contact: Mikkel R Andersen, MD, Ph.D.; Phone Number: +4538672796; Email: mikkel.rathsach.andersen@regionh.dk
    • Contact: Mathias R Vergmann; Phone Number: +4538677456; Email: mathias.randrup.vergmann@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 86 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Semiconductor knee-sleeves; Knee-sleeves containing semiconductor elements within the fabric constitute the intervention arm.	Device: Semiconductor Knee Sleeves; semiconductor elements germanium and carbon within the cotton fabric; Other Names: Incrediwear
Placebo Comparator: Placebo knee-sleeves; Cotton knee-sleeves constitute the placebo arm.	Device: Cotton Knee Sleeves (Placebo); cotton fabric knee sleeves; Other Names: Incrediwear (Placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Pain	Visual Analog Scale 0-100, 0-no pain, 100 maximum pain	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee function	Oxford Knee Score, 0-48, 0-indication of low level of knee function, 48 indication of satisfactory knee function	3 months
Knee Range of Motion (ROM)	Range of motion for the knee, extension-flexion- 0-140	3 months
Life Quality assessment	SF-36 score, (Short Form Survey-36), 36 life quality items questionaire, 0-lowest score, 100-highest score	3 months

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Investigators: Study Chair: Mikkel R Andersen, MD., Ph.D., Gentofte Hospital; Principal Investigator: Mathias R Vergmann, Physiotherapeut, Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; Knee; Arthrosis; Knee-Sleeves; Semiconductor
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: H-20080028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All study results will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes