Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 9:26 PM
Study NCT ID:
NCT04020861
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2019-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-03', 'studyFirstSubmitDate': '2019-07-05', 'studyFirstSubmitQcDate': '2019-07-12', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity: Numerical Rating Scale (Pain NRS)', 'timeFrame': '2 weeks after randomization', 'description': 'Pain intensity will be evaluated using an 11-point (0-10) Numerical Rating Scale (Pain NRS), which is a simple and easy-to-use measuring scale that consists of a sequence of numbers from zero to 10, in which zero represents "no pain" and 10 represents "the worst pain imaginable". The pain evaluation will be carried out verbally with the patient reporting the pain intensity.'}], 'secondaryOutcomes': [{'measure': 'Pain intensity: Numerical Rating Scale (Pain NRS)', 'timeFrame': '6 weeks after randomization', 'description': 'Pain intensity will be evaluated using an 11-point (0-10) Numerical Rating Scale (Pain NRS), which is a simple and easy-to-use measuring scale that consists of a sequence of numbers from zero to 10, in which zero represents "no pain" and 10 represents "the worst pain imaginable". The pain evaluation will be carried out verbally with the patient reporting the pain intensity.'}, {'measure': 'Pain intensity at movement: Numerical Rating Scale (Pain NRS)', 'timeFrame': '2 weeks after randomization', 'description': 'Pain intensity will be evaluated during the cervical movements of flexion, extension, right and left lateral inclination and right and left rotation, using an 11-point (0-10) Numerical Rating Scale (Pain NRS)'}, {'measure': 'Neck disability', 'timeFrame': '2 weeks after randomization', 'description': 'Neck disability will be evaluated using neck disability index (NDI) that consists of a 10-item questionnaire that assess the impact of pain on daily activities using a score from 0 to 5 for each section, with higher values indicating more severe impact.'}, {'measure': 'Cervical range of motion', 'timeFrame': '2 weeks after randomization', 'description': 'Cervical range of motion will be measured with a fleximeter'}, {'measure': 'Pressure Pain Threshold', 'timeFrame': '2 weeks after randomization', 'description': 'Pressure pain threshold (PPT) in the neck, shoulder girdle and anterior tibialis muscle will be measured using a Somedic Type II pressure algometer'}, {'measure': 'Pain temporal summation (TS)', 'timeFrame': '2 weeks after randomization', 'description': 'Temporal summation (TS) will be induced by a pressure algometer. Ten (10) stimuli with a pressure of 40 kPa/s of the mean value of algometry performed prior on the upper trapezius. Patients will be asked about their pain using NRS at the first, fifth and tenth stimulus.'}, {'measure': 'Conditioned pain modulation (CPM)', 'timeFrame': '2 weeks after randomization', 'description': 'The conditioned stimulus for eliciting CPM will be the cold pressor test (Cold Water Bath test to the hand) and the test stimulus will be the assessment of PPT on the upper trapezius muscle.'}, {'measure': 'Depressive symptoms', 'timeFrame': '2 weeks after randomization', 'description': 'The depressive symptoms will be performed using Beck Depression Inventory (BDI). The scale consists of items including symptoms and attitudes whose intensity range from neutral to a maximum level of severity, rated from 0 to 3.'}, {'measure': 'Pain catastrophizing', 'timeFrame': '2 weeks after randomization', 'description': 'Pain catastrophizing will be performed with Pain Catastrophizing Scale (PCS) - The PCS is a self-administered questionnaire that consists of 13 items to assess catastrophizers. The items are rated on a 5-point Likert-type scale in which both intensity and frequency information are represented, with the following five levels of response for each Likert item: (0) not at all, (1) to a slight degree, (3) to a moderate degree, (4) to a great degree, (5) and all the time. The total score is computed by summation of all items and the total score ranges from 0 to 52 points. Higher scores indicate greater catastrophic pain.'}, {'measure': 'Change in patient perception of quality of life:12-Item Short-Form Health Survey (SF-12)', 'timeFrame': '2 weeks after randomization', 'description': 'The quality of life will be performed using 12-Item Short-Form Health Survey (SF-12) version 2 questionnaire. This is a self-report measure that assesses physical (Physical Component Summary - PCS) and mental (Mental Component Summary - MCS) health on a scale of 0 - 100. Higher scores represent better levels of quality of life.'}, {'measure': 'Analgesic intake', 'timeFrame': '2 weeks after randomization', 'description': 'Anlgesic intake will be evaluated asking to the patients all analgesic medications (opioids and non-opioids) taken one week prior to evaluation and during the treatment.'}, {'measure': 'Global perceived effect (GPE)', 'timeFrame': '2 weeks and 6 weeks after randomization', 'description': 'Global perceived effect will be evaluated by an 11 - point (- 5 to + 5) Global Perceived Effect Scale. It consists of an 11-point scale that ranges from -5 (vastly worse) through 0 (no change) to 5 (completely recovered).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electrophysical agents', 'Low-level laser therapy', 'TENS', 'Neck pain', 'Chronic pain'], 'conditions': ['Chronic Neck Pain']}, 'referencesModule': {'references': [{'pmid': '32080103', 'type': 'DERIVED', 'citation': 'Rampazo EP, de Andrade ALM, da Silva VR, Back CGN, Liebano RE. Photobiomodulation therapy and transcutaneous electrical nerve stimulation on chronic neck pain patients: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(8):e19191. doi: 10.1097/MD.0000000000019191.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy isolated and combinaded of photobiomodulation therapy with low level laser therapy and the transcutaneous electrical nerve stimulation.', 'detailedDescription': 'Non-specific chronic neck pain patients will be treated with low-level laser therapy and/or trancutaneous electricam nerve stimulation. They will receive 10 sessions of treatment. Before and after the treatment physical measures and psychosocial factors will be evaluted to verificy the efficay these electrophysical agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non-specific chronic neck pain, defined as pain or discomfort in the posterior cervical region between the superior nuchal line and the first thoracic spinous process and / or shoulder girdle;\n* Neck pain for at least 3 months;\n* Neck Disability Index (NDI) score of 5 points or higher;\n* Numeric Rating Scale (NRS) score of 3 or higher to pain intensity;\n* Aged between 18 and 65 years;\n* Men and women\n\nExclusion Criteria:\n\n* Neck pain associated with nerve root compromise (measured by clinical examination of dermatomes, myotomes and reflexes);\n* Previous spinal surgery;\n* Patients treated with physical therapy for neck pain in the last 3 months previous the study;\n* Severe spinal disorders such as fractures, tumors, inflammatory and infectious diseases;\n* Any contraindication to low level laser therapy or transcutaneous electrical nerve stimulation;\n* Rheumatic, metabolic, neurological or cardiopulmonary diseases;\n* Patients who require artificial cardiac pacemakers;\n* Skin diseases, mainly at the current application site;\n* Tumors or cancer historic in the last 5 years;\n* Pregnancy;\n* If the patient started any physical activity in the last 2 weeks.'}, 'identificationModule': {'nctId': 'NCT04020861', 'briefTitle': 'Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Sao Carlos'}, 'officialTitle': 'Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients', 'orgStudyIdInfo': {'id': 'CAAE: 81711417.0.0000.5504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PBM + TENS', 'description': 'The patients will be submitted to the active PBM and active TENS', 'interventionNames': ['Device: Active PBM', 'Device: Active TENS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PBM', 'description': 'The patients will be submitted to the active PBMT and placebo TENS', 'interventionNames': ['Device: Active PBM', 'Device: Placebo TENS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TENS', 'description': 'The patients will be submitted to the placebo PBMT and active TENS', 'interventionNames': ['Device: Active TENS', 'Device: Placebo PBM']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The patients will be submitted to the placebo PBMT and placebo TENS.', 'interventionNames': ['Device: Placebo PBM', 'Device: Placebo TENS']}], 'interventions': [{'name': 'Active PBM', 'type': 'DEVICE', 'description': 'To active photobiomodulation therapy (PBMT) the patient will be oriented to lie preferably in prone. The treatment area will be defined according to painful area. In the active group will be used the followings parameters: low-level laser therapy, 808 nm, 4 infrared diodes, 180 mW, 9 J. In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied.', 'armGroupLabels': ['PBM', 'PBM + TENS']}, {'name': 'Active TENS', 'type': 'DEVICE', 'description': 'To active transcutaneous electrical nerve stimulation (TENS) the patient will be oriented to lie preferably in prone. Two or four electrodes standard square self-adhesive electrodes (5 × 5 cm2) will be positioned according to the painful area related by patient. It will be used the following parameters: frequency of 100 Hz, pulse duration of 125 µs (positive phase), 30 minutes of current stimulation and the pulse amplitude will be increased until the patient reports a strong but comfortable paresthesia (including motor level stimulation but no painful TENS). The amplitude will be adjusted (if necessary) each 5 minutes to keep a strong but comfortable paresthesia.', 'armGroupLabels': ['PBM + TENS', 'TENS']}, {'name': 'Placebo PBM', 'type': 'DEVICE', 'description': 'In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied.', 'armGroupLabels': ['Placebo', 'TENS']}, {'name': 'Placebo TENS', 'type': 'DEVICE', 'description': 'To placebo transcutaneous electrical nerve stimulation (TENS) Two or four electrodes standard square self-adhesive electrodes (5 × 5 cm2) will be positioned according to the painful area related by patient. This device was customized to deliver a current for 30 seconds (both channels) and then ramp off over the next 15 seconds so that it will be active for a total of 45 seconds. This will permit the patient to fell the TENS sensation while applying the settings.', 'armGroupLabels': ['PBM', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13565-905', 'city': 'São Carlos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Federal University São Carlos', 'geoPoint': {'lat': -22.0175, 'lon': -47.89083}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES', 'description': 'The data will be available upon requested of principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Sao Carlos', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Richard Eloin Liebano', 'investigatorAffiliation': 'Universidade Federal de Sao Carlos'}}}}