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.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedStudy Start
First participant enrolled
November 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedSeptember 25, 2023
September 1, 2023
1.1 years
January 6, 2022
September 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee Pain
Visual Analog Scale 0-100, 0-no pain, 100 maximum pain
3 months
Secondary Outcomes (3)
Knee function
3 months
Knee Range of Motion (ROM)
3 months
Life Quality assessment
3 months
Study Arms (2)
Semiconductor knee-sleeves
ACTIVE COMPARATORKnee-sleeves containing semiconductor elements within the fabric constitute the intervention arm.
Placebo knee-sleeves
PLACEBO COMPARATORCotton knee-sleeves constitute the placebo arm.
Interventions
semiconductor elements germanium and carbon within the cotton fabric
cotton fabric knee sleeves
Eligibility Criteria
You may qualify if:
- Arthrosis of the Knee
- Surgery not yet indicated
- years old
- Male or female
- Compliant patient
- BMI less than 35
- Able to understand Danish sufficiently for written consent
You may not qualify if:
- Rheumatoid Arthritis
- Previous blood clots
- BMI greater than 35
- Varicosities on operative leg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gentofte Hospital
Copenhagen, 2900, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mikkel R Andersen, MD., Ph.D.
Gentofte Hospital
- PRINCIPAL INVESTIGATOR
Mathias R Vergmann, Physiotherapeut
Gentofte Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Investigated knee sleeves appear identical, a printed code reveals to investigator if knee sleeves contains semiconductors (intervention group) or are cotton only (placebo group). Participants, care provider and outcome assessors are blinded to intervention/placebo grouping.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD., Ph.D., Associate prof.
Study Record Dates
First Submitted
January 6, 2022
First Posted
February 25, 2022
Study Start
November 30, 2022
Primary Completion
January 1, 2024
Study Completion
January 1, 2026
Last Updated
September 25, 2023
Record last verified: 2023-09