Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT04698733
Status:
UNKNOWN
Last Update Posted:
2021-03-05
First Post:
2021-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Veteran Affairs Osteoarthritis Knee Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Level Assessment', 'timeFrame': '12 weeks', 'description': 'Change in pain associated with osteoarthritis of the knee during all visits (#1-13). Pain will be assessed with NRS (numeric rating scale) where 0 is no pain and 10 is worst possible pain.'}], 'secondaryOutcomes': [{'measure': 'Changes in mobility', 'timeFrame': '12 weeks', 'description': 'Mobility will be assessed via Timed Up \\& Go (TUG) assessment during visits #1, 12, 13. Participants are timed getting up from sitting in a standard armchair, walking approximately 3 meters, turning, walking back to the chair, and sitting down.'}, {'measure': 'Changes in patient-relevant outcomes', 'timeFrame': '12 weeks', 'description': 'Patient-relevant outcomes will be assessed via the Knee Injury and Osteoarthritis Outcome Score (KOOS) during visits #1, 12 and 13. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. KOOS does not use a numerical scale, it uses a qualitative scale with the following options: never, rarely, sometimes, often and always.'}, {'measure': 'Changes in brief pain inventory', 'timeFrame': '12 weeks', 'description': 'The brief pain inventory (BPI) will be used to assess changes in pain during visits #1, 12, and 13. This scale ranges from 0 to 10. The numerical value 0 can represent "no pain" or "does not interfere". The numerical value 10 can represent "pain as bad as you can imagine" or completely interferes".'}, {'measure': 'Changes in the use of pain medication', 'timeFrame': '12 weeks', 'description': 'Medication usage will be recorded during visits #1, 12, 13 and any increase/decrease in pain medications will be assessed.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['electric stimulation', 'microcurrent', 'knee pain', 'knee injury'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'A clinical study at the Dallas Veterans Affairs, is being proposed to test the efficacy of a novel electrical stimulation platform named the Pro-Sport Ultra® device by AVAZZIA to reduce pain and increase activity level in patients with knee osteoarthritis.', 'detailedDescription': 'The primary objective of this study is to document the possible short- and long-term decrease in pain as scored by participants on a Numeric Rating Scale (NRS) after use of Avazzia PRO-Sport Ultra® device with pulsed microcurrent in patients with osteoarthritis of the knee.\n\nPatients with a clinical diagnosis of Osteoarthritis (OA) of the knee for a minimum of 6 months will be recruited for this study. Their OA has not responded/is not responding to treatment and continuing symptoms interfere with normal function. Additionally, patients will have a pain score of 3 or greater on the NRS even with pain medication.\n\nSecondary objectives include changes in:\n\n* Mobility via a Timed Up \\& Go assessment (TUG). Participants are timed getting up from sitting in a standard armchair, walking approximately 3 meters, turning, walking back to the chair, and sitting down.\n* Patient-relevant outcomes via the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.\n* Brief Pain Inventory - Short Form\n* Use of pain medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a prior diagnosis (Dx) of OA of the knee and have had a trial of conservative treatment for a minimum of 6 months without successful results due to continuing symptoms that interfere with normal function\n* Age \\>18 - \\<70 years old\n* Males/Females of all ethnicities\n* NRS pain score of 3 or greater while on medication\n* Ability to understand the informed consent document before signing it\n* For female participants, is at least 4 years post-menopausal, has a history of hysterectomy, has had bilateral tubal ligation, or consents to use two forms of birth control.\n\nExclusion Criteria:\n\n* Poor diabetic control (A1c\\>11 within the last 3 months)\n* Diagnosis of acute sciatica and/or acute vasculitis\n* Diabetic peripheral neuropathy\n* Lower extremity surgery within the last 6 months\n* Knee replacement\n* Uncontrolled mood disorders, such as depression, anxiety\n* Drug or substance abuse within past 90 days\n* Injury that results in a change in pain level due to causes other than osteoarthritis (i.e., a recent fall or accident)\n* Epilepsy\n* Open wounds around knee joint\n* Active litigation, workers compensation\n* An electrically implanted device such as a pacemaker, neural stimulator, etc.\n* Currently pregnant, nursing, or may become pregnant.'}, 'identificationModule': {'nctId': 'NCT04698733', 'briefTitle': 'Veteran Affairs Osteoarthritis Knee Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avazzia, Inc'}, 'officialTitle': 'Efficacy of a Pulsed Microcurrent in the Non-Invasive Treatment of Knee Pain From Osteoarthritis', 'orgStudyIdInfo': {'id': 'RA-191011-01-VA-OA-Knee'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: BEST™ Pro-Sport Ultra® microcurrent device', 'description': 'Participants will receive 2 treatments a week on nonconsecutive days for 6 weeks in the clinic with an active electrical stimulation device.', 'interventionNames': ['Device: BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device']}], 'interventions': [{'name': 'BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device', 'type': 'DEVICE', 'description': 'Participants will receive two (2) 20-minute treatments a week on nonconsecutive days for 6 weeks in the clinic. At the end of 6 weeks, participants will have a 6-week pause in treatment.\n\nActive Avazzia PRO-Sport Ultra® medical device, BEST™ HVPC microcurrent electrical stimulation, FDA cleared for pain relief', 'armGroupLabels': ['Experimental: BEST™ Pro-Sport Ultra® microcurrent device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elomn M Gbedey', 'role': 'CONTACT', 'email': 'elomn.gbedey@va.gov', 'phone': '214-857-0304'}, {'name': 'Thiru Annaswamy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Veteran Affairs North Texas Healthcare System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Arelly Villarreal, BS', 'role': 'CONTACT', 'email': 'arelly@avazzia.com', 'phone': '2145752820'}, {'name': 'Elonm M Gbedey, BA', 'role': 'CONTACT', 'email': 'elonm.gbedey@va.gov', 'phone': '2148570304'}], 'overallOfficials': [{'name': 'Thiru Annaswamy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Veteran Affairs North Texas Healthcare System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avazzia, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}