Clinical trial NCT05255835: The Effect of Semiconductor Knee Sleeves on Pain in Osteoarthritis of the Knee.
Official title: A Randomized Prospective Study to Evaluate the Effect of Semiconductor Knee Sleeves on Pain in Osteoarthritis of the Knee.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Knee
Arthrosis
Pain
Osteoarthritis
Knee-Sleeves
Semiconductor
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 50
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (RCT)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Pain
timeFrame: 3 months
Secondary outcomes:
measure: Knee function
timeFrame: 3 months
measure: Knee Range of Motion (ROM)
timeFrame: 3 months
measure: Life Quality assessment
timeFrame: 3 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: Gentofte Hospital
name: Mikkel R Andersen, MD., Ph.D.
role: STUDY_CHAIR
affiliation: Gentofte Hospital
name: Mathias R Vergmann, Physiotherapeut
role: PRINCIPAL_INVESTIGATOR
References: