Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT03493334
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2018-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Feedback in Chronic Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056228', 'term': 'Feedback, Sensory'}], 'ancestors': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}, {'id': 'D025461', 'term': 'Feedback, Physiological'}, {'id': 'D006706', 'term': 'Homeostasis'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neck pain intensity', 'timeFrame': 'Baseline', 'description': 'Measured using a 10 cm visual analogue scale'}, {'measure': 'Neck pain intensity', 'timeFrame': 'Immediately after the intervention (at 30 minutes)', 'description': 'Measured using a 10 cm visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'Pain location', 'timeFrame': 'Baseline', 'description': 'Measured using a body chart'}, {'measure': 'Pain location', 'timeFrame': 'Immediately after the intervention (at 30 minutes)', 'description': 'Measured using a body chart'}, {'measure': 'Time for pain to return to baseline levels', 'timeFrame': 'Immediately after the intervention (at 30 minutes)', 'description': 'Measured with a chronometer'}, {'measure': 'Pain disability', 'timeFrame': 'Baseline', 'description': 'Measured using the Neck Disability Questionnaire (range: 0-50 and higher scores are indicative of more disability)'}, {'measure': 'Pain disability', 'timeFrame': 'Immediately after the intervention (at 30 minutes)', 'description': 'Measured using the Neck Disability Questionnaire (range: 0-50 and higher scores are indicative of more disability)'}, {'measure': 'Neck range of motion', 'timeFrame': 'Baseline', 'description': 'Measured using a goniometer'}, {'measure': 'Neck range of motion', 'timeFrame': 'Immediately after the intervention (at 30 minutes)', 'description': 'Measured using a goniometer'}, {'measure': 'Kinesiophobia', 'timeFrame': 'Baseline', 'description': 'Measured using the Tampa Scale of Kinsesiophobia (Range: 13-52 and higher values are indicative of a higher fear of movement.'}, {'measure': 'Kinesiophobia', 'timeFrame': 'Immediately after the intervention (at 30 minutes)', 'description': 'Measured using the Tampa Scale of Kinsesiophobia (Range: 13-52 and higher values are indicative of a higher fear of movement.'}, {'measure': 'Catastrophyzing', 'timeFrame': 'Baseline', 'description': 'Measured using the Pain Catastrophyzing Scale (range: 0-52 and higher scores and indicative of higher pain catastrophyzing)'}, {'measure': 'Catastrophyzing', 'timeFrame': 'Immediately after the intervention (at 30 minutes)', 'description': 'Measured using the Pain Catastrophyzing Scale (range: 0-52 and higher scores and indicative of higher pain catastrophyzing)'}, {'measure': 'Anxiety', 'timeFrame': 'Baseline', 'description': 'Measured using the State-Trait Anxiety Scale, which consists of 2 sub-scales, one measures trait anxiety and the other measures state anxiety; both scales have an independent score that ranges from 20 to 80 and higher scores are indicative of higher anxiety.'}, {'measure': 'Anxiety', 'timeFrame': 'Immediately after the intervention (at 30 minutes)', 'description': 'Measured using the State-Trait Anxiety Scale, which consists of 2 sub-scales, one measures trait anxiety and the other measures state anxiety; both scales have an independent score that ranges from 20 to 80 and higher scores are indicative of higher anxiety.'}, {'measure': 'Neck perception', 'timeFrame': 'Baseline', 'description': 'Assessed by asking participants to draw their neck as they perceive it to be'}, {'measure': 'Neck perception', 'timeFrame': 'Immediately after the intervention (at 30 minutes)', 'description': 'Assessed by asking participants to draw their neck as they perceive it to be'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the impact of visual feedback of the posterior region of the cervical spine on pain intensity and range of motion.', 'detailedDescription': '60 patients with chronic idiopathic neck pain will be randomly assigned into one of two groups: a group receiving visual feedback when performing 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation) and a group performing the same task without visual feedback. Participants will be assessed for pain intensity, pain location, disability, range of motion, kinesiophobia, catastrophizing and anxiety both at baseline and after visual the intervention (i.e., neck movements with and without visual feedback).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To have idiopathic neck pain defined as neck pain unrelated to any known pathology or lesion felt at least once a week in the last 3 months, located between the nuchal line and a horizontal line passing through T1 and pain intensity of at least 3 in the visual analogue scale.\n\nExclusion Criteria:\n\n* History of cervical or facial trauma, radiculopathy, history of surgery in the vertebral segment in question, congenital anomalies involving the spine (cervical, thoracic and lumbar spine) or any neurological or rheumatic pathology, and, finally, evidence of significant visual changes, or of deficits not corrected by lenses or glasses.'}, 'identificationModule': {'nctId': 'NCT03493334', 'briefTitle': 'Visual Feedback in Chronic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Aveiro University'}, 'officialTitle': 'Impacto do Feedback Visual da região Posterior da Coluna Cervical, na Intensidade da Dor e Amplitude de Movimento, em Utentes Com Dor Cervical crónica idiopática', 'orgStudyIdInfo': {'id': '12-CED/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Visual feedback', 'description': 'Participants in this group will receive visual feedback of their neck when performing 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation).', 'interventionNames': ['Other: Visual feedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No visual feedback', 'description': 'Participants in this group will perform 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation) without feedback.', 'interventionNames': ['Other: No visual feedback']}], 'interventions': [{'name': 'Visual feedback', 'type': 'OTHER', 'description': 'Visual feedback of the neck will be given to participants using two mirrors while performing neck movements.', 'armGroupLabels': ['Visual feedback']}, {'name': 'No visual feedback', 'type': 'OTHER', 'description': 'Participants will be asked to perform active movements of their neck with the mirrors covered.', 'armGroupLabels': ['No visual feedback']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Figueira da Foz Municipality', 'country': 'Portugal', 'facility': 'Clínica de Diagnóstico e Terapêutica - Hellman, Lda', 'geoPoint': {'lat': 40.15085, 'lon': -8.86179}}], 'overallOfficials': [{'name': 'Anabela Silva, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aveiro University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aveiro University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Anabela G Silva', 'investigatorAffiliation': 'Aveiro University'}}}}