Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-01-08 @ 4:20 AM
Study NCT ID:
NCT03362333
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Neuroscience Education and Exercise
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'At the beginning', 'description': 'Measured using the visual analogue scale'}, {'measure': 'Pain intensity', 'timeFrame': '5 weeks', 'description': 'Measured using the visual analogue scale'}, {'measure': 'Pain intensity', 'timeFrame': 'At 3 months', 'description': 'Measured using the visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'Deep neck flexor endurance', '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': 'Deep neck flexor endurance', '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 extensors endurance', '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 extensors endurance', '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', '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', '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': 'Pressure pain thresholds', 'timeFrame': 'At the beginning', 'description': 'Method of assessment - psychophysical test; Pressure was applied over the trapezius and at C5-C6 with a algometer until the participant first felt pain. The results was the quantity of force (in Kgf) supported by participants.'}, {'measure': 'Pressure pain thresholds', 'timeFrame': '5 weeks', 'description': 'Method of assessment - psychophysical test; Pressure was applied over the trapezius and at C5-C6 with a algometer until the participant first felt pain. The results was the quantity of force (in Kgf) supported by participants.'}, {'measure': 'Disability', 'timeFrame': 'At the beginning', 'description': 'Method of assessment - the neck pain disability index'}, {'measure': 'Disability', 'timeFrame': '5 weeks', 'description': 'Method of assessment - the neck pain disability index'}, {'measure': 'Disability', 'timeFrame': '3 months', 'description': 'Method of assessment - the neck pain disability index'}, {'measure': 'catastrophizing', 'timeFrame': 'at beginning', 'description': 'Method of assessment - Pain catastrophising scale'}, {'measure': 'catastrophizing', 'timeFrame': '5 weeks', 'description': 'Method of assessment - Pain catastrophising scale'}, {'measure': 'catastrophizing', 'timeFrame': '3 months', 'description': 'Method of assessment - Pain catastrophising scale'}, {'measure': 'fear of movement', 'timeFrame': 'At the beginning', 'description': 'method of assessment - the Tampa Scale'}, {'measure': 'fear of movement', 'timeFrame': '5 weeks', 'description': 'method of assessment - the Tampa Scale'}, {'measure': 'fear of movement', 'timeFrame': '3 months', 'description': 'method of assessment - the Tampa Scale'}, {'measure': 'Knowledge of pain neurophysiology', 'timeFrame': 'at beginning', 'description': 'method of assessment - scale; the neurophysiology of pain questionnaire'}, {'measure': 'Knowledge of pain neurophysiology', 'timeFrame': '5 weeks', 'description': 'method of assessment - scale; the neurophysiology of pain questionnaire'}, {'measure': 'Knowledge of pain neurophysiology', 'timeFrame': '3 months', 'description': 'method of assessment - scale; the neurophysiology of pain questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.', 'detailedDescription': 'This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.\n\nUniversity students with chronic neck pain were randomly allocated to receive pain neuroscience education and exercise or exercise only and assessed at baseline, after the intervention and at 3 months follow up. Outcome variables were pain intensity (primary outcome), disability, fear of movement, catastrophizing, knowledge of pain neurophysiology, pressure pain thresholds and neck and scapular muscle endurance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants could enter the study if they had chronic idiopathic neck pain, defined as pain felt in the neck at least once a week in the previous 3 months and for which no cause had been established. Furthermore, they were required to have a minimum pain intensity in the previous week of 2 in the visual analogue scale.\n\nExclusion Criteria:\n\n* Participants were excluded if they had had physiotherapy for their neck pain in the 6 months previous to the study, if they had rheumatic, nervous, cardiac and/or respiratory pathology that could prevent or make it difficult to do the exercises. Exclusion criteria were ascertained by self-report.'}, 'identificationModule': {'nctId': 'NCT03362333', 'briefTitle': 'Pain Neuroscience Education and Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Aveiro University'}, 'officialTitle': 'Pain Neuroscience Education and Exercise Versus Exercise for University Students With Chronic Idiopathic Neck Pain: a Randomized, Controlled and Single Blind Study', 'orgStudyIdInfo': {'id': 'PCEDCSS-FMUP 18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pain neuroscience education and exercise', 'description': 'This group received pain neuroscience education and exercise once a week over 4 weeks', 'interventionNames': ['Other: Exercise', 'Other: Pain neuroscience education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'description': 'This group received exercise directed at the neck and shoulder regions once a week over 4 weeks', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular stabilizer muscles.', 'armGroupLabels': ['Exercise', 'pain neuroscience education and exercise']}, {'name': 'Pain neuroscience education', 'type': 'OTHER', 'description': 'Pain neuroscience education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience.', 'armGroupLabels': ['pain neuroscience education and exercise']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anabela Silva, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aveiro'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aveiro University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Anabela G Silva', 'investigatorAffiliation': 'Aveiro University'}}}}