Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-30 @ 7:23 AM
Study NCT ID:
NCT06301061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focal Microvibration and Chronic Lumbosacral Radicular Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D011843', 'term': 'Radiculopathy'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}, {'id': 'D000639', 'term': 'Amitriptyline'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-03', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-03-03', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '12 months', 'description': 'Change in pain intensity with numeric rating scale (NRS): NRS ranges from 0 (no pain) to 10 (the the worst pain imaginable)'}], 'secondaryOutcomes': [{'measure': 'Pain interference in daily life', 'timeFrame': '12 months', 'description': 'Pain interference in patient daily life: mood, general activity, social relationship, work ability measured by Brief Pain Inventory (BPI). BPI is a 9 item self-administered questionnaire and every item score ranges from 0 to 10: a higher score indicates a worst outcome.'}, {'measure': 'Disability', 'timeFrame': '12 months', 'description': 'Disability related to pain severity measured by and Oswestry Disability Index (ODI). ODI score ranges from 0 to 100; a higher score on the ODI indicates a more severe disability caused by low back pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Chronic', 'Lumbosacral Radiculopathy', 'Radicular; Neuropathic']}, 'referencesModule': {'references': [{'pmid': '38057548', 'type': 'RESULT', 'citation': 'Buonanno P, Iacovazzo C, Marra A, de Siena AU, Josu T, Zampi M, Sedda D, Servillo G, Vargas M. Potential Role of Focal Microvibration (Equistasi(R)) in the Management of Chronic Pain: A Pilot Study. Pain Ther. 2024 Feb;13(1):185-198. doi: 10.1007/s40122-023-00562-6. Epub 2023 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate the effectiveness of focal microvibration on patients affected by chronic lumbosacral radicular pain. The main question\\[s\\] it aims to answer are:\n\n* Can focal microvibration improve pain in this patient population?\n* Can focal microvibration improve quality of life in these patients? Participants will attach to their skin four little devices (10x20x0,5mm) delivering focal microvibration in the painful area according to researchers indications for 6 hours/day every day except Thursday and Sunday.\n\nResearchers will compare patients treated with focal microvibration to patients treated with a sham device and to patients treated with standard pharmacological therapy.', 'detailedDescription': "This is the first randomized controlled study aiming to assess the potential use of focal microvibration for the management of chronic lumbosacral radicular pain which is the pain consequent to the compression of a spinal nerve root. Focal microvibration has been so far used to treat gait disorders and instability consequent to diseases such as Parkinson's disease, stroke, ataxia, multiple sclerosis with impressive results and no reported side effects. Our trial involves three arms: one arm treated with a device able to deliver focal microvibration, one arm treated with a sham device, and one arm treated with standard pharmacological therapy according to international guidelines. Patients with the active and with sham devices will attach them on their skin for 6 hours/day except on Thursday and Sunday: this application schedule with two days of treatment suspension has intended to avoid habituation to the sub-perception microvibration stimulation. The follow up will be 12 months and periodic visits will be performed after 7, 15 30, 45, 60, 90, 180, and 360 days of treatment. All the patients enrolled in the study will have access to rescue analgesic drugs such as paracetamol 1g and tramadol 100mg in case on excessive pain. Randomization will be performed by a computer-generated sequence. During the follow up visits, patients will be asked to fill questionnaires to explore and monitor pain intensity and pain interference in daily life: brief pain inventory (BPI) and Oswestry disability index (ODI)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pain duration≥6 months\n* Magnetic resonance imaging (MRI) showing compression of lumbosacral nerve roots\n* Neuropathic symptoms in the innervation territory of the compressed spinal nerve roots\n* Monolateral pain\n* Pain intensity: moderate-severe i.e. numeric rating scale (NRS)≥4.\n\nExclusion Criteria:\n\n* Psychiatric patients\n* Cancer patients\n* Patients affected by disease characterized by spasticity or muscular stiffness:\n\nParkinson's disease, multiple sclerosis, stroke, spine injuries.\n\n* Patients with spinal or dorsal root ganglion stimulators\n* Patients undergone central of peripheral stimulation in the past 3 months\n* Patients affected by fibromyalgia.\n* Patients undergone central nervous system surgery\n* Patients with reduced renal function eGFR≤60ml/min/1,73m2"}, 'identificationModule': {'nctId': 'NCT06301061', 'briefTitle': 'Focal Microvibration and Chronic Lumbosacral Radicular Pain', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Effectiveness of Focal Microvibration in the Management of Chronic Lumbosacral Radicular Pain: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'PB001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients treated with Focal Microvibration', 'description': 'Patients will be treated with focal microvibration through the application on the skin of four devices for 6 hours/day every day except thursady and Sunday.', 'interventionNames': ['Device: Equistasi®']}, {'type': 'SHAM_COMPARATOR', 'label': 'Patients treated with a Sham device', 'description': 'Patients will be treated with four sham device which will be attached on the skin for 6 hours/day every day except thursady and Sunday.', 'interventionNames': ['Device: Sham']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients treated with standard pharmacological approach', 'description': 'Patients will be treated with standard pharmacological therapy', 'interventionNames': ['Drug: Gabapentin; Pregabalin; Duloxetine; Amitriptyline']}], 'interventions': [{'name': 'Equistasi®', 'type': 'DEVICE', 'description': 'Four devices will be attached to the skin according the indication of the investigators for 6 hours/day every day except Thursday and Sunday', 'armGroupLabels': ['Patients treated with Focal Microvibration']}, {'name': 'Sham', 'type': 'DEVICE', 'otherNames': ['No active device'], 'description': 'Four devices similar to the active one but not able to deliver the microvibration will be applied to the patients', 'armGroupLabels': ['Patients treated with a Sham device']}, {'name': 'Gabapentin; Pregabalin; Duloxetine; Amitriptyline', 'type': 'DRUG', 'otherNames': ['Drugs for neuropathic pain'], 'description': 'Patients will be treated with drugs (gabapentinoids, Serotonin-norepinephrine reuptake inhibitor, tricyclic antidepressants, opioids) according to guidelines.', 'armGroupLabels': ['Patients treated with standard pharmacological approach']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Maria Vargas', 'investigatorAffiliation': 'Federico II University'}}}}