Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-03-21 @ 7:12 PM
Study NCT ID:
NCT03248505
Status:
UNKNOWN
Last Update Posted:
2017-08-14
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryotherapy and TENS on 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D007053', 'term': 'Ice'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D014867', 'term': 'Water'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D014887', 'term': 'Weather'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3x6'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-08-09', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Painful sensation', 'timeFrame': 'Evaluation of pain sensation 25 minutes after the application of the intervention.', 'description': 'Pain sensation measured by pain numerical rating scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain, Mechanical']}, 'descriptionModule': {'briefSummary': 'This study aim analyze the immediate effects of conventional transcutaneous electrical nerve stimulation (TENS) and Burst TENS combined or not with cryotherapy in patients with non-specific low back pain.\n\nAll subjects will be submitted to an evaluation of the painful sensation, through the numerical rating scale, and pain threshold, through algometry, before, immediately after the intervention and 25 minutes after.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 50 years;\n* Have chronic non-specific low back pain.\n\nExclusion Criteria:\n\n* Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);\n* Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);\n* Fibromyalgia\n* Corticosteroid treatment in the previous two weeks;\n* Antiinflammatory treatment in the previous 24 hours;\n* Contraindications to the use of Kinesio Taping (allergy or intolerance);\n* Score of three or less on Visual Analogue Scale of the first day;\n* Pregnancy;\n* Ice allergy.'}, 'identificationModule': {'nctId': 'NCT03248505', 'acronym': 'CTLBP', 'briefTitle': 'Cryotherapy and TENS on Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio Grande do Norte'}, 'officialTitle': 'Immediate Effects of Conventional TENS and Burst TENS Combined With Cryotherapy in the Non-specific Low Back Pain', 'orgStudyIdInfo': {'id': 'TENS_LBP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo TENS', 'description': 'TENS unit turned on, but with zero amplitude.', 'interventionNames': ['Other: Placebo TENS']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional TENS', 'description': 'Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude.', 'interventionNames': ['Device: Conventional TENS']}, {'type': 'EXPERIMENTAL', 'label': 'Burst TENS', 'description': 'Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.', 'interventionNames': ['Device: Burst TENS']}, {'type': 'EXPERIMENTAL', 'label': 'Cryotherapy', 'description': '1,5 Kg crushed ice pack', 'interventionNames': ['Other: Cryotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Burst TENS + Cryotherapy', 'description': 'Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus an ice pack of 1,5 Kg.', 'interventionNames': ['Device: Burst TENS + Cryotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional TENS + Cryotherapy', 'description': 'Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude plus an ice pack of 1,5 Kg.', 'interventionNames': ['Device: Conventional TENS + Cryotherapy']}], 'interventions': [{'name': 'Conventional TENS', 'type': 'DEVICE', 'otherNames': ['Transcutaneous Electrical Nerve Stimulation'], 'description': 'Transcutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) with two electrodes in each side of the lumbar spinal.', 'armGroupLabels': ['Conventional TENS']}, {'name': 'Burst TENS', 'type': 'DEVICE', 'otherNames': ['Burst-modulated TENS'], 'description': 'Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.', 'armGroupLabels': ['Burst TENS']}, {'name': 'Cryotherapy', 'type': 'OTHER', 'otherNames': ['Ice'], 'description': '1,5 Kg of crushed ice pack on lumbar spine.', 'armGroupLabels': ['Cryotherapy']}, {'name': 'Burst TENS + Cryotherapy', 'type': 'DEVICE', 'otherNames': ['Burst-modulated TENS and Ice'], 'description': 'Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus 1,5 Kg of crushed ice pack on lumbar spine.', 'armGroupLabels': ['Burst TENS + Cryotherapy']}, {'name': 'Conventional TENS + Cryotherapy', 'type': 'DEVICE', 'otherNames': ['Transcutaneous Electrical Nerve Stimulation + Ice'], 'description': 'Transcutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) plus s 1,5 Kg of crushed ice pack on lumbar spine.', 'armGroupLabels': ['Conventional TENS + Cryotherapy']}, {'name': 'Placebo TENS', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': 'TENS device turned on, but with zero amplitude.', 'armGroupLabels': ['Placebo TENS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59140-840', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Jamilson S Brasileiro, PhD', 'role': 'CONTACT', 'email': 'brasileiro@ufrnet.br', 'phone': '+55 84 3342-2008'}], 'facility': 'Federal University of Rio Grande do Norte', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}], 'centralContacts': [{'name': 'Jamilson S Brasileiro, PhD', 'role': 'CONTACT', 'email': 'brasileiro@ufrnet.br', 'phone': '+55 84 3342-2015'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio Grande do Norte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Physiotherapy', 'investigatorFullName': 'Jamilson Simões Brasileiro', 'investigatorAffiliation': 'Universidade Federal do Rio Grande do Norte'}}}}