Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT04646720
Status:
UNKNOWN
Last Update Posted:
2020-11-30
First Post:
2020-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Teleassessment in Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], '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': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2020-11-13', 'studyFirstSubmitQcDate': '2020-11-23', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in range of movement', 'timeFrame': 'Baseline', 'description': 'Changes in range of movement were measured with goniometry and expressed in degrees.'}, {'measure': 'Changes in trigger points', 'timeFrame': 'Baseline', 'description': 'Changes in trigger points were measured following the Travels and Simons protocol in the trapezius, suboccipitalis, scalenes and sternocleidomastoid muscles. The number od trigger points found was registered.'}, {'measure': 'Changes in neck endurance (anterior)', 'timeFrame': 'Baseline', 'description': 'Changes in neck endurance were measured using an endurance test for the anterior neck muscles. The time performing the test was registered.'}, {'measure': 'Changes in neck endurance (posterior)', 'timeFrame': 'Baseline', 'description': 'Changes in neck endurance were measured using an endurance test for the posterior neck muscles. The time performing the test was registered.'}, {'measure': 'Changes in quality of life', 'timeFrame': 'Baseline', 'description': 'Changes in quality of life were measured using the Euroqol 5dimensions which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. It also includes a visual analogue scale to report the health status from 0 to 100.'}, {'measure': 'Changes in quality of life (Visual Analogue Scale)', 'timeFrame': 'Baseline', 'description': 'Changes in quality of life were measured using the Euroqol 5dimensions which comprises a visual analogue scale to report the health status from 0 to 100.'}], 'secondaryOutcomes': [{'measure': 'Changes in kinesiophobia', 'timeFrame': 'Baseline', 'description': 'Changes in kinesiophobia were measured using the Tampa Scale for Kinesiophobia (TSK) which is one of the most frequently employed measures for assessing pain-related fear in pain patients.'}, {'measure': 'Changes in functionality', 'timeFrame': 'Baseline', 'description': 'Changes in functionality were measured using the World Health Organization Disability Assessment Schedule, WHODAS-2, which provides a global measure of disability and 7 domain-specific scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Pain', 'Assessment, Self', 'Kinesiophobia']}, 'descriptionModule': {'briefSummary': 'New technologies have improved the aproach of patients with different pathologies. Neck pain is a prevalent pathology in physical therapy clinics. Evaluating patients with an electronical device could decrease the services saturation and the proffesionals overload.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic neck pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of neck pain\n* Between 18 and 65 years\n* Accepted to sign the informed consent\n\nExclusion Criteria:\n\n* Cognitive impairment.\n* Traumatic accidents.\n* Other orthopedic or neurologic pathology.'}, 'identificationModule': {'nctId': 'NCT04646720', 'acronym': 'Teleneck', 'briefTitle': 'Teleassessment in Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Teleassessment in Neck Pain Patients: an Observational Study', 'orgStudyIdInfo': {'id': 'DF0092UG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neck pain patients', 'description': 'Patients with neck pain evaluated with new technologies and face-to-face'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marie Carmen Valenza', 'investigatorAffiliation': 'Universidad de Granada'}}}}