The Effect of Semiconductor Knee Sleeves on Pain in Osteoarthritis of the Knee.
NCT ID: NCT05255835
Last Updated: 2023-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2022-11-30
2026-01-01
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Participants, care provider and outcome assessors are blinded to intervention/placebo grouping.
Study Groups
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Semiconductor knee-sleeves
Knee-sleeves containing semiconductor elements within the fabric constitute the intervention arm.
Semiconductor Knee Sleeves
semiconductor elements germanium and carbon within the cotton fabric
Placebo knee-sleeves
Cotton knee-sleeves constitute the placebo arm.
Cotton Knee Sleeves (Placebo)
cotton fabric knee sleeves
Interventions
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Semiconductor Knee Sleeves
semiconductor elements germanium and carbon within the cotton fabric
Cotton Knee Sleeves (Placebo)
cotton fabric knee sleeves
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Previous blood clots
* BMI greater than 35
* Varicosities on operative leg
90 Years
ALL
No
Sponsors
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Herlev and Gentofte Hospital
OTHER
Responsible Party
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Mikkel Rathsach Andersen
MD., Ph.D., Associate prof.
Principal Investigators
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Mikkel R Andersen, MD., Ph.D.
Role: STUDY_CHAIR
Gentofte Hospital
Mathias R Vergmann, Physiotherapeut
Role: PRINCIPAL_INVESTIGATOR
Gentofte Hospital
Locations
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Gentofte Hospital
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-20080028
Identifier Type: -
Identifier Source: org_study_id
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