Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT06559358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-19
First Post:
2024-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subthreshold Stimulation Versus Suprathreshold Stimulation in People With Chronic Low Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2024-08-06', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '2-3 months', 'description': 'Neck pain intensity will be assessed by the visual analog scale (VAS). Participants will be asked to explain their present pain by putting a mark on a 10 mm horizontal line with 0 degrees indicating "no pain" and 10 indicating the "worst possible pain"'}, {'measure': 'Pressure threshold', 'timeFrame': '2-3 months', 'description': "Myofascial trigger points' sensitivity will be measured by a pressure-pain algometer from upper trapezius muscle."}, {'measure': 'Electromyography', 'timeFrame': '2-3 months', 'description': 'The EMG activity from the upper trapezius muscle will be recorded during rest and voluntary maximum contraction.'}, {'measure': 'Range of motion', 'timeFrame': '2-3 months', 'description': 'Flexion, lateral rotation to both sides, lateral flexion to both sides'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Trigger Point Pain, Myofascial']}, 'descriptionModule': {'briefSummary': 'this trial will involve three groups. Group 1 will receive subthreshold stimulation. Group 2 will receive suprathreshold stimulation. Group 3 will receive shame treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 40 to 65 years old participated in this study, 2\n* Having neck pain for more than 6 months with a grade five or greater on the visual analog scale\n* Having one or more trigger points in the upper trapezius muscle,\n* A significant increase in neck muscle EMG activity indicates the presence of tender points.\n\nExclusion Criteria:\n\n* Taking non-pharmacological therapies (e.g., acupuncture, physical therapy, osteopathy)\n* Taking oral or intravenous pain therapy, intramuscular or subcutaneous injection of cortisone, or local anesthetics during the study period,\n* Presence of any contraindication to electrical current including pregnancy, epilepsy, cardiac arrhythmia, cardiac surgery, implanted pacemaker or defibrillator, previous surgery in the spinal cord, infectious diseases of the spinal cord, malignant tumors with or without secondary blastomas in the spinal cord, severe radicular pain with acute paralysis in the extremities'}, 'identificationModule': {'nctId': 'NCT06559358', 'briefTitle': 'Subthreshold Stimulation Versus Suprathreshold Stimulation in People With Chronic Low Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Subthreshold Stimulation Versus Suprathreshold Stimulation in People With Chronic Low Neck Pain', 'orgStudyIdInfo': {'id': 'Beni-Suef University2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'This group will receive subthreshold stimulation', 'interventionNames': ['Device: electrical stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'This group will receive suprathreshold stimulation', 'interventionNames': ['Device: electrical stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group 3', 'description': 'This group will receive no stimulation', 'interventionNames': ['Device: electrical stimulation']}], 'interventions': [{'name': 'electrical stimulation', 'type': 'DEVICE', 'description': 'A two-channel portable electrical stimulation unit (BTL-4620, Czech Republic).', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Lecturer', 'investigatorFullName': 'Ayman Mohamed', 'investigatorAffiliation': 'Beni-Suef University'}}}}