Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT02827994
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2016-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic 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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-06', 'studyFirstSubmitDate': '2016-06-23', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'At the beginning', 'description': 'Method of assessment - Visual analogue scale'}, {'measure': 'Pain intensity', 'timeFrame': '5 weeks', 'description': 'Method of assessment - Visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'Neck pain frequency', 'timeFrame': 'At the beginning', 'description': 'Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)'}, {'measure': 'Neck pain frequency', 'timeFrame': '5 weeks', 'description': 'Method of assessment - a question on neck pain frequency in the previous week (never, seldom, occasionally, often, always)'}, {'measure': 'Neck pain duration', 'timeFrame': 'At the beginning', 'description': 'Method of assessment - a question on neck pain duration (how long have you have neck pain?)'}, {'measure': 'Neck pain duration', 'timeFrame': '5 weeks', 'description': 'Method of assessment - a question on neck pain duration (how long have you have neck pain?)'}, {'measure': 'Neck pain associated disability', 'timeFrame': 'At the beginning', 'description': 'Method of assessment - a disability index with 5 questions on neck pain associated disability'}, {'measure': 'Neck pain associated disability', 'timeFrame': '5 weeks', 'description': 'Method of assessment - a disability index with 5 questions on neck pain associated disability'}, {'measure': 'Neck flexor muscles endurance test', 'timeFrame': 'At the beginning', 'description': 'Method of assessment - physical test; the participant is in supine and he/she is asked to flex the upper cervical spine, move their head away from the couch approximately 2.5 cm and then maintain this position for as long as possible. The test result is the time (in seconds) that each participant holds the position.'}, {'measure': 'Neck flexor muscles endurance test', 'timeFrame': '5 weeks', 'description': 'Method of assessment - physical test; the participant is in supine and he/she is asked to flex the upper cervical spine, move their head away from the couch approximately 2.5 cm and then maintain this position for as long as possible. The test result is the time (in seconds) that each participant holds the position.'}, {'measure': 'Neck extensor muscles endurance test', 'timeFrame': 'At the beginning', 'description': 'Method of assessment - physical test; the participant is in prone and position, head neutral, and supporting 2 Kg weight hanging from it. Participants were asked to support this weight for as long as possible while maintaining the neutral head positioning. The test result is the time (in seconds) that each participant holds the position.'}, {'measure': 'Neck extensor muscles endurance test', 'timeFrame': '5 weeks', 'description': 'Method of assessment - physical test; the participant is in prone and position, head neutral, and supporting 2 Kg weight hanging from it. Participants were asked to support this weight for as long as possible while maintaining the neutral head positioning. The test result is the time (in seconds) that each participant holds the position.'}, {'measure': "Scapular stabilizers' endurance test", 'timeFrame': 'At the beginning', 'description': 'Method of assessment - physical test; Method of assessment - physical test; Participants were standing with the shoulders and elbows flexed at 90º, while pulling both extremities of a dynamometer to reach 1 Kg of force. The test result is the time (in seconds) that each participants was able to hold this position.'}, {'measure': "Scapular stabilizers' endurance test", 'timeFrame': '5 weeks', 'description': 'Method of assessment - physical test; Method of assessment - physical test; Participants were standing with the shoulders and elbows flexed at 90º, while pulling both extremities of a dynamometer to reach 1 Kg of force. The test result is the time (in seconds) that each participants was able to hold this position.'}, {'measure': 'State-trait anxiety inventory', 'timeFrame': 'At the beginning', 'description': 'Method of assessment - scale'}, {'measure': 'State-trait anxiety inventory', 'timeFrame': '5 weeks', 'description': 'Method of assessment - scale'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'At the beginning', 'description': 'Method of assessment - scale'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': '5 weeks', 'description': 'Method of assessment - scale'}, {'measure': 'Neurophysiology of pain questionnaire', 'timeFrame': 'At the beginning', 'description': 'Method of assessment - questionnaire'}, {'measure': 'Neurophysiology of pain questionnaire', 'timeFrame': '5 weeks', 'description': 'Method of assessment - questionnaire'}, {'measure': "Patients' Global Impression of Change", 'timeFrame': '5 weeks', 'description': 'Method of assessment - scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'This study compared the effectiveness of pain neurophysiology education and neck/shoulder exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).', 'detailedDescription': 'Forty three adolescents with chronic idiopathic neck pain were randomly allocated to receive pain neurophysiology education and shoulder/neck exercises (n=21) or no intervention (n=22). Data on pain intensity (Visual Analogue Scale), pain disability, neck flexor and extensor muscles endurance, scapulae stabilizers endurance, pain catastrophizing (Pain catastrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and knowledge of pain neurophysiology (Neurophysiology of Pain Questionnaire) were collected. Measurements were taken before and after the intervention.\n\nStatistical analysis were performed using a mixed-methods ANOVA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be invited to enter the study participants had to have chronic idiopathic neck/shoulder pain, defined as pain felt in the neck/shoulder regions at least once a week in the previous 3 months.\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT02827994', 'briefTitle': 'Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Aveiro University'}, 'officialTitle': 'Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain: a School-based Pilot, Randomised and Controlled Study', 'orgStudyIdInfo': {'id': 'PCEDCSS_FMUP 5/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education and exercise', 'description': 'The intervention included neurophysiology of pain education and exercises.', 'interventionNames': ['Other: neurophysiology of pain education and exercises']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'This group received no intervention as participants were students that were not seeking treatment for their pain.'}], 'interventions': [{'name': 'neurophysiology of pain education and exercises', 'type': 'OTHER', 'description': 'Pain neurophysiology education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. It was delivered in small groups (4 to 7 participants). A total of 4 sessions were delivered over 4 weeks (1 session per week). Each session took between 45 minutes and 1 hour.\n\nExercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular muscles delivered over 3 sessions (the first session covered pain neurophysiology education only). Each exercise was performed in 3 series of 10 repetitions. The number of exercises targeting the same group of muscles increased from one in the 2nd session to 2/3 in the 4th session.', 'armGroupLabels': ['Education and exercise']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aveiro University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Anabela G Silva', 'investigatorAffiliation': 'Aveiro University'}}}}