Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:35 PM
Study NCT ID:
NCT04753567
Status:
UNKNOWN
Last Update Posted:
2021-04-20
First Post:
2021-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
nCap Pain Relief Patch vs. Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-16', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score using VAS scale', 'timeFrame': 'After 30 minutes of use', 'description': '0-10 pain scale'}], 'secondaryOutcomes': [{'measure': 'WOMAC score', 'timeFrame': '3 weeks', 'description': 'arthritis assessment score'}, {'measure': 'Sustained pain response', 'timeFrame': '3 weeks', 'description': '0-10 VAS pain score'}, {'measure': 'Global assessment question', 'timeFrame': '3 weeks', 'description': 'How the patient feels they are doing'}, {'measure': 'Pain medication monitoring', 'timeFrame': '3 weeks', 'description': 'Tylenol use'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['pain, arthritis'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether use of the nCap Medical Nano-Capacitive pain relief patch reduces subject pain as measured by subject pain scores, WOMAC scores (pain, stiffness and physical function), global assessment scores, and pain medication change as compared to participants randomly assigned to the sham patch group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meet Altman's clinical criteria for Knee Osteoarthritis\n* Male and Female Adults age 40-79\n* VAS pain score of \\> 4 at the beginning of the study\n\nExclusion Criteria:\n\n* Subject unable to walk unassisted. Participants must be able to stand/walk for 30 minutes\n* Inability to read and understand English. Must be able to complete WOMAC scale and questionnaires\n* Severe systemic disease limiting ability to ambulate for 30 minutes\n* Use of a TENS unit for one week before study or during study\n* History of total knee replacement on the affected knee\n* Knee surgery on the affected knee in the last 12 months\n* Injection into the knee in the last 6 months\n* Knee pain \\< 411\n* Inability to cognitively understand consent form or research study, or inability to give consent\n* Diagnosis of fibromyalgia, rheumatoid arthritis, gout, dysplasia, septic arthritis, knee pain from other diseases.\n* Malignancy\n* Injury to knee within 6 months\n* Concomitant use of opioids, NSAIDS or other analgesics for 1 week before trial (or 5 half-lives, whichever is greater)9, or during trial with exception of acetaminophen.\n* Pregnant or lactating\n* Poor general health (ASA classification of IV+)"}, 'identificationModule': {'nctId': 'NCT04753567', 'briefTitle': 'nCap Pain Relief Patch vs. Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'nCap Medical'}, 'officialTitle': 'nCap Medical Nano-Capacitive Pain Relief Patch vs Placebo, a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '00127554'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Actual pain patch', 'interventionNames': ['Device: nCap pain relief patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham patch', 'interventionNames': ['Device: Sham Patch']}], 'interventions': [{'name': 'nCap pain relief patch', 'type': 'DEVICE', 'description': 'Each participant will be randomly assigned to sham or actual patch. Patches will be worn for 3 weeks. Pain and quality of life will be assessed and compared between groups', 'armGroupLabels': ['Actual pain patch']}, {'name': 'Sham Patch', 'type': 'DEVICE', 'description': 'Sham patch will be worn for 3 weeks exactly like actual pain patch', 'armGroupLabels': ['Sham patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tatjana Warren, PhD', 'role': 'CONTACT', 'phone': '801-970-2577'}], 'facility': 'Knee Arthritis Clinical Trial Officew', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Tatjana Warren, PhD CRNA', 'role': 'CONTACT', 'email': 'tsbevans@yahoo.com', 'phone': '8584051003'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'nCap Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}