Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05255835
Status:
RECRUITING
Last Update Posted:
2023-09-25
First Post:
2022-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Semiconductor Knee Sleeves on Pain in Osteoarthritis of the Knee.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigated knee sleeves appear identical, a printed code reveals to investigator if knee sleeves contains semiconductors (intervention group) or are cotton only (placebo group).\n\nParticipants, care provider and outcome assessors are blinded to intervention/placebo grouping.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial (RCT)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2022-02-24', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Pain', 'timeFrame': '3 months', 'description': 'Visual Analog Scale 0-100, 0-no pain, 100 maximum pain'}], 'secondaryOutcomes': [{'measure': 'Knee function', 'timeFrame': '3 months', 'description': 'Oxford Knee Score, 0-48, 0-indication of low level of knee function, 48 indication of satisfactory knee function'}, {'measure': 'Knee Range of Motion (ROM)', 'timeFrame': '3 months', 'description': 'Range of motion for the knee, extension-flexion- 0-140'}, {'measure': 'Life Quality assessment', 'timeFrame': '3 months', 'description': 'SF-36 score, (Short Form Survey-36), 36 life quality items questionaire, 0-lowest score, 100-highest score'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee', 'Arthrosis', 'Pain', 'Osteoarthritis', 'Knee-Sleeves', 'Semiconductor'], 'conditions': ['Osteo Arthritis Knee']}, 'descriptionModule': {'briefSummary': '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.\n\nAims:\n\nThe 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.', 'detailedDescription': "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:\n\n* Accelerated Recovery\n* Reduced Swelling\n* Optimized Performance\n* Reduced Fatigue\n* Thermoregulation\n\nInvestigators wish to investigate a possible effect on knee pain and function in patients with osteoarthritis of the knee.\n\nSubject Enrollment:\n\nSubjects 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.\n\nThis is a prospective study that will require informed consent.\n\nStudy 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.\n\nStudy Population: Estimated enrollment Target enrollment - 50 patients\n\n* 25 patients with the semiconductor knee sleeve.\n* 25 patients with the placebo sleeve."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Arthrosis of the Knee\n* Surgery not yet indicated\n* 40-90 years old\n* Male or female\n* Compliant patient\n* BMI less than 35\n* Able to understand Danish sufficiently for written consent\n\nExclusion Criteria:\n\n* Rheumatoid Arthritis\n* Previous blood clots\n* BMI greater than 35\n* Varicosities on operative leg'}, 'identificationModule': {'nctId': 'NCT05255835', 'briefTitle': 'The Effect of Semiconductor Knee Sleeves on Pain in Osteoarthritis of the Knee.', 'organization': {'class': 'OTHER', 'fullName': 'Herlev and Gentofte Hospital'}, 'officialTitle': 'A Randomized Prospective Study to Evaluate the Effect of Semiconductor Knee Sleeves on Pain in Osteoarthritis of the Knee.', 'orgStudyIdInfo': {'id': 'H-20080028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Semiconductor knee-sleeves', 'description': 'Knee-sleeves containing semiconductor elements within the fabric constitute the intervention arm.', 'interventionNames': ['Device: Semiconductor Knee Sleeves']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo knee-sleeves', 'description': 'Cotton knee-sleeves constitute the placebo arm.', 'interventionNames': ['Device: Cotton Knee Sleeves (Placebo)']}], 'interventions': [{'name': 'Semiconductor Knee Sleeves', 'type': 'DEVICE', 'otherNames': ['Incrediwear'], 'description': 'semiconductor elements germanium and carbon within the cotton fabric', 'armGroupLabels': ['Semiconductor knee-sleeves']}, {'name': 'Cotton Knee Sleeves (Placebo)', 'type': 'DEVICE', 'otherNames': ['Incrediwear (Placebo)'], 'description': 'cotton fabric knee sleeves', 'armGroupLabels': ['Placebo knee-sleeves']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mikkel R Andersen, MD, Ph.D.', 'role': 'CONTACT', 'email': 'mikkel.rathsach.andersen@regionh.dk', 'phone': '+4538672796'}, {'name': 'Mathias R Vergmann', 'role': 'CONTACT', 'email': 'mathias.randrup.vergmann@regionh.dk', 'phone': '+4538677456'}], 'facility': 'Gentofte Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Mikkel R Andersen, MD, Ph.D.', 'role': 'CONTACT', 'email': 'mikkel.rathsach.andersen@regionh.dk', 'phone': '+4538672796'}, {'name': 'Mathias R Vergmann, Physiotherapuet', 'role': 'CONTACT', 'email': 'mathias.randrup.vergmann@regionh.dk', 'phone': '38677456'}], 'overallOfficials': [{'name': 'Mikkel R Andersen, MD., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Gentofte Hospital'}, {'name': 'Mathias R Vergmann, Physiotherapeut', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gentofte Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'All study results will be published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev and Gentofte Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD., Ph.D., Associate prof.', 'investigatorFullName': 'Mikkel Rathsach Andersen', 'investigatorAffiliation': 'Herlev and Gentofte Hospital'}}}}