Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-26 @ 1:09 AM
Study NCT ID:
NCT06053034
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2023-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of the Solio Alfa Care Plus Device in Treating Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2023-09-10', 'studyFirstSubmitQcDate': '2023-09-21', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '1 month', 'description': 'The Pain Numerical Rating Scale (NRS) - it is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain'}], 'secondaryOutcomes': [{'measure': 'Disability score', 'timeFrame': '1 month', 'description': "10 questions about the participant's daily experience with their back pain and how it affects diverse day to day activities (e.g., social life, work life, walking and standing, etc.)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Objectives: This double-blind, randomized, prospective, single-centre study evaluated the effectiveness of radiofrequency therapy by the SOLIO Alfa Cure Plus in the treatment of a non-specific low back pain (LBP) Methods: Thirty-seven patients completed pain, disability, and lower back flexibility scales. Randomization was obtained by having an equal amount of sham and real devices and distributing them randomly to patients out of a box where the devices were.', 'detailedDescription': "Studies have shown that some generally recommended first-line medications for low back pain (LPB) are only slightly more effective than placebo controls in double-blind randomized trials \\[10\\]. For instance, physical exercise in combination with manual therapy often produces short-term results \\[15\\], such as the epidural corticosteroid injection that presents a complication rate between 0% and 9.65%. At the same time, various energy sources are thought to have great potential for both general healing and pain relief \\[11\\] \\[12\\] and there are several available devices that make use of this technology \\[13\\].\n\nInfrared therapy (IR) can reach muscles, nerves and even bones, where it reduces inflammation by accessing inner layers of tissues. The use of IR therapy has been shown to accelerate wound healing, ease arthritis knee pain, increase endorphin levels, and activate neuromodulators \\[19\\] without any side effects. According to a recent study, IR therapy is beneficial for chronic non-specific LBP sufferers in terms of comfort, function, lumbar range of motion, and back extensor endurance \\[20\\].\n\nRadio frequency (RF) therapy shows promise as a healing strategy in a variety of etiologies \\[22\\]- \\[24\\] and it one of the most common energy sources for producing therapeutic heat levels. RF energy is delivered to soft tissue as part of the mechanism's biophysical therapeutic mode to relieve pain, as well as enhancing collagen formation, vascularization, and collagen structure in the tissue \\[22\\]- \\[24\\]. Another energy source is the tow-level laser treatment (LLLT), known to induce analgesia, reduce inflammation, and promote healing in a variety of musculoskeletal diseases. This technique is based on the theory that light causes biochemical changes in cells like photosynthesis in plants. \\[26\\]. LLLT may also be used as an adjuvant therapy for pain management in patients with neurologic impairments and neuropathic pain \\[27\\].\n\nThe techniques are potential tools for controlling pain in a variety of etiologies, but additional research appears to be needed to fully develop the therapeutic and mechanistic role of these techniques. No device combining all three approaches has ever been objectively assessed in a randomized clinical trial for pain management. The SOLIO Alfa Cure Plus is the only home-use device with FDA clearance that uses the proprietary synergy of three energy sources (IR, RF, and LLLT), and this study aims to assess the SOLIO Alfa Cure Plus's efficiency in providing pain relief. This technology is the first non-invasive and patented home RF device. SOLIO Alfa Cure Plus uses continuous RF, the internal controller reduces the RF power while reaching the treatment temperature of 39- 42 Celsius.\n\nThese three treatment modalities are hypothesized to affect the physiological issue at many levels, causing tissue regeneration and pain relief at the cellular and tissue levels, as well as changing sensory nerves and cell molecular makeup \\[18\\], \\[20\\], \\[25\\], \\[27\\]. Our goal was to determine whether the RF component of the treatment has an effect on back pain relief."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with LBP lasting 6 weeks and less than 6 months (NRS) of 4 or higher), between 18 to 70 years old that possessed assistance of family members\n\nExclusion Criteria:\n\n* patients with fibromyalgia, pregnancy, pacemaker implant, hyper coagulation, cognitive impairment, psychosis diagnosis, addiction, opiate usage, malignant cancer, and BMI \\> 35 or 18.5'}, 'identificationModule': {'nctId': 'NCT06053034', 'briefTitle': 'Effectiveness of the Solio Alfa Care Plus Device in Treating Low Back Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Assessing the Effectiveness of the Solio Alfa Cure Plus Device in Treating Low Back Pain: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': '847521SMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham device', 'description': "a round device equipped with a strap for hand holding, it is to be used while connected to a socket. The device is used by an assistant (usually a family member) on the participant's back for 20 minutes while moving it around in circles on the lower back.", 'interventionNames': ['Device: Solio alpha cure plus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Solio Alpha Plus', 'description': "The SOLIO Alfa Cure Plus Device for patients with LBP- is a round device equipped with a strap for hand holding, it is to be used while connected to a socket. The device is used by an assistant (usually a family member) on the participant's back for 20 minutes while moving it around in circles on the lower back. It should be mentioned this is the first trial in Home-RF using an external", 'interventionNames': ['Device: Solio alpha cure plus']}], 'interventions': [{'name': 'Solio alpha cure plus', 'type': 'DEVICE', 'description': "The SOLIO Alfa Cure Plus is the only home-use device with FDA clearance that uses the proprietary synergy of three energy sources (IR, RF, and LLLT), and this study aims to assess the SOLIO Alfa Cure Plus's efficiency in providing pain relief. This technology is the first noninvasive and patented home RF device. SOLIO Alfa Cure Plus uses continuous RF, the internal controller reduces the RF power while reaching the treatment temperature of 39- 42 Celsius.The SOLIO Alfa Cure Plus Device is a round device equipped with a strap for hand holding, it is to be used while connected to a socket. The device is used by an assistant (usually a family member) on the participant's back for 20 minutes while moving it around in circles on the lower back.", 'armGroupLabels': ['Sham device', 'Solio Alpha Plus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Pain Clinic', 'investigatorFullName': 'Dr. Itay GoorAryeh', 'investigatorAffiliation': 'Sheba Medical Center'}}}}