Osteo Arthritis KneeNCT05255835
The Effect of Semiconductor Knee Sleeves on Pain in Osteoarthritis of the Knee.
A study testing Semiconductor Knee Sleeves in people with Osteo Arthritis Knee, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Semiconductor Knee Sleeves
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Nov 2022to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Rheumatoid Arthritis
- Previous blood clots
- BMI greater than 35
- Varicosities on operative leg
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Gentofte Hospital
Copenhagen, 2900
Mikkel R Andersen, MD, Ph.D., +4538672796, mikkel.rathsach.andersen@regionh.dk
Mathias R Vergmann, +4538677456, mathias.randrup.vergmann@regionh.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Semiconductor Knee Sleeves, Cotton Knee Sleeves (Placebo)
- Keywords
- Knee, Arthrosis, Pain, Osteoarthritis, Knee-Sleeves, Semiconductor
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semiconductor Knee SleevesDevice
Also called Incrediwear
semiconductor elements germanium and carbon within the cotton fabric
Cotton Knee Sleeves (Placebo)Device
Also called Incrediwear (Placebo)
cotton fabric knee sleeves
| Study group | Role | What they receive |
|---|---|---|
| Semiconductor knee-sleeves | Active comparator | Knee-sleeves containing semiconductor elements within the fabric constitute the intervention arm. Receives: Device: Semiconductor Knee Sleeves |
| Placebo knee-sleeves | Placebo comparator | Cotton knee-sleeves constitute the placebo arm. Receives: Device: Cotton Knee Sleeves (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Pain
Visual Analog Scale 0-100, 0-no pain, 100 maximum pain
Measured: 3 months
Secondary outcomes (3)
Knee function
Oxford Knee Score, 0-48, 0-indication of low level of knee function, 48 indication of satisfactory knee function
Measured: 3 months
Knee Range of Motion (ROM)
Range of motion for the knee, extension-flexion- 0-140
Measured: 3 months
Life Quality assessment
SF-36 score, (Short Form Survey-36), 36 life quality items questionaire, 0-lowest score, 100-highest score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start30 Nov 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (RCT)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikkel Rathsach Andersen, Herlev and Gentofte Hospital
- Investigators
- Mikkel R Andersen, MD., Ph.D., Study chair, Gentofte HospitalMathias R Vergmann, Physiotherapeut, Principal investigator, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255835
- Sponsor's protocol ID
- H-20080028
- Status last verified
- Sep 2023
- First submitted
- 6 Jan 2022
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All study results will be published
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Study to Evaluate the Effect of Semiconductor Knee Sleeves on Pain in Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT05255835
- Acronym / sponsor ID
- H-20080028
- Conditions
- Osteo Arthritis Knee
- Keywords
- Knee, Arthrosis, Pain, Osteoarthritis, Knee-Sleeves, Semiconductor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Semiconductor knee-sleeves | Active comparator | Device: Semiconductor Knee SleevesKnee-sleeves containing semiconductor elements within the fabric constitute the intervention arm. |
| Placebo knee-sleeves | Placebo comparator | Device: Cotton Knee Sleeves (Placebo)Cotton knee-sleeves constitute the placebo arm. |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Arthrosis of the Knee
- Surgery not yet indicated
- 40-90 years old
- Male or female
- Compliant patient
Key exclusion criteria (4 listed)
- Rheumatoid Arthritis
- Previous blood clots
- BMI greater than 35
- Varicosities on operative leg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semiconductor Knee SleevesAlso: Incrediwearsemiconductor elements germanium and carbon within the cotton fabric | Device | Semiconductor knee-sleeves |
| Cotton Knee Sleeves (Placebo)Also: Incrediwear (Placebo)cotton fabric knee sleeves | Device | Placebo knee-sleeves |
Primary outcome
Knee Pain
Time frame: 3 months
Visual Analog Scale 0-100, 0-no pain, 100 maximum pain
3 secondary outcomes
Knee function
Time frame: 3 months
Knee Range of Motion (ROM)
Time frame: 3 months
Life Quality assessment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: Undecided. All study results will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikkel R Andersen, MD., Ph.D. study chair
Gentofte Hospital
Mathias R Vergmann, Physiotherapeut principal investigator
Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semiconductor Knee Sleeves in people with Osteo Arthritis Knee, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikkel R Andersen, MD, Ph.D. (+4538672796, mikkel.rathsach.andersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.