Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 5:14 AM
Study NCT ID:
NCT04528160
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2020-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Neuroscience Education for Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, '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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inclusion rate', 'timeFrame': '9 weeks', 'description': 'ratio between the number of participants included in the study and the total number of people contacted'}, {'measure': 'Refusal rate', 'timeFrame': '9 weeks', 'description': 'ratio between the number of individuals who refused to participate in the study and the number of individuals contacted'}, {'measure': 'Exclusion rate', 'timeFrame': '9 weeks', 'description': 'ratio between the number of individuals excluded for not meeting the inclusion criteria and the total number of individuals contacted'}, {'measure': 'Dropout rate', 'timeFrame': '9 weeks', 'description': 'ratio between the number of participants who abandoned the study and the number of participants who completed the initial assessment'}, {'measure': 'Retention rate', 'timeFrame': '9 weeks', 'description': 'ratio between the number of participants who completed the final assessment and the number of participants who completed the initial assessment'}, {'measure': 'Number of participants reporting adverse events', 'timeFrame': '9 weeks', 'description': 'Self-report of any adverse event perceived as being related to the intervention'}, {'measure': 'Perception of participants towards the intervention structure and content', 'timeFrame': '9 weeks', 'description': 'Semi-structured interviews with participants on the structure and content of the intervention'}], 'secondaryOutcomes': [{'measure': 'Pain severity and interference', 'timeFrame': 'Baseline', 'description': 'Assessed using the Brief Pain Inventory questionnaire (range 0-110 and higher values are indicative of higher pain severity and interference)'}, {'measure': 'Pain severity and interference', 'timeFrame': '9 weeks', 'description': 'Assessed using the Brief Pain Inventory questionnaire (range 0-110 and higher values are indicative of higher pain severity and interference)'}, {'measure': 'Pain severity and interference', 'timeFrame': '6 months', 'description': 'Assessed using the Brief Pain Inventory questionnaire (range 0-110 and higher values are indicative of higher pain severity and interference)'}, {'measure': 'Pain catastrophizing', 'timeFrame': 'Baseline', 'description': 'Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)'}, {'measure': 'Pain catastrophizing', 'timeFrame': '9 weeks', 'description': 'Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)'}, {'measure': 'Pain catastrophizing', 'timeFrame': '6 months', 'description': 'Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)'}, {'measure': 'Depression', 'timeFrame': 'Baseline', 'description': 'Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)'}, {'measure': 'Depression', 'timeFrame': '9 weeks', 'description': 'Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)'}, {'measure': 'Depression', 'timeFrame': '6 months', 'description': 'Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)'}, {'measure': 'Fear of movement', 'timeFrame': 'Baseline', 'description': 'Assessed using the TAMPA Scale, which assesses fear of movement (range: 13-52 and higher values are indicative of higher levels of fear of movement)'}, {'measure': 'Fear of movement', 'timeFrame': '6 weeks', 'description': 'Assessed using the TAMPA Scale, which assesses fear of movement (range: 13-52 and higher values are indicative of higher levels of fear of movement)'}, {'measure': 'Fear of movement', 'timeFrame': '6 months', 'description': 'Assessed using the TAMPA Scale, which assesses fear of movement (range: 13-52 and higher values are indicative of higher levels of fear of movement)'}, {'measure': 'Knowledge of pain neuroscience', 'timeFrame': 'Baseline', 'description': 'Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)'}, {'measure': 'Knowledge of pain neuroscience', 'timeFrame': '9 weeks', 'description': 'Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)'}, {'measure': 'Knowledge of pain neuroscience', 'timeFrame': '6 months', 'description': 'Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)'}, {'measure': 'Gait velocity', 'timeFrame': 'Baseline', 'description': 'Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters'}, {'measure': 'Gait velocity', 'timeFrame': '9 weeks', 'description': 'Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters'}, {'measure': 'Gait velocity', 'timeFrame': '6 months', 'description': 'Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters'}, {'measure': 'Postural control', 'timeFrame': 'Baseline', 'description': 'Assessed using the Timed up and go test - the time, in seconds, that it takes to stand from a chair, walk 3 meters, turn, walk another 3 meters to sit in the chair.'}, {'measure': 'Postural control', 'timeFrame': '9 weeks', 'description': 'Assessed using the Timed up and go test - the time, in seconds, that it takes to stand from a chair, walk 3 meters, turn, walk another 3 meters to sit in the chair.'}, {'measure': 'Postural control', 'timeFrame': '6 months', 'description': 'Assessed using the Timed up and go test - the time, in seconds, that it takes to stand from a chair, walk 3 meters, turn, walk another 3 meters to sit in the chair.'}, {'measure': 'Self-perceived disability', 'timeFrame': 'Baseline', 'description': 'assessed using the World Health Organization Disability Assessment Schedule 2.0 - 12-item version of WHODAS 2.0) questionnaire (range: 12-60 and higher values are indicative of higher levels of disability)'}, {'measure': 'Self-perceived disability', 'timeFrame': '9 weeks', 'description': 'assessed using the World Health Organization Disability Assessment Schedule 2.0 - 12-item version of WHODAS 2.0) questionnaire (range: 12-60 and higher values are indicative of higher levels of disability)'}, {'measure': 'Self-perceived disability', 'timeFrame': '6 months', 'description': 'assessed using the World Health Organization Disability Assessment Schedule 2.0 - 12-item version of WHODAS 2.0) questionnaire (range: 12-60 and higher values are indicative of higher levels of disability)'}, {'measure': 'Perception of change', 'timeFrame': '9 weeks', 'description': 'Assessed using the Global Perception of Change scale (answer is given using a 7-point likert scale from 1- no change to 7 - a great deal better and a considerable improvement that has made all the difference)'}, {'measure': 'Perception of change', 'timeFrame': '6 months', 'description': 'Assessed using the Global Perception of Change scale (answer is given using a 7-point likert scale from 1- no change to 7 - a great deal better and a considerable improvement that has made all the difference)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '34417415', 'type': 'DERIVED', 'citation': 'Heleno E, Andias R, Neto M, Silva AG. A Feasibility Study of Pain Neuroscience Education and Exercise for Community-Dwelling Older Adults With Chronic Pain. J Geriatr Phys Ther. 2023 Jan-Mar 01;46(1):26-35. doi: 10.1519/JPT.0000000000000327. Epub 2021 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the feasibility of using pain neuroscience education for older adults with chronic pain from primary care services. It will have a group of participants receiving pain neuroscience education and exercise and a group receiving usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be able to read and write and have chronic pain (defined as pain lasting 3 months or more and felt at least once a week during these 3 months ) anywhere in the body.\n\nExclusion Criteria:\n\n* presence of pathology of the nervous or cardiovascular systems, cancer, or having had a surgery in the last 6 months or the presence of a condition for which the practice of therapeutic exercise could be contraindicated.'}, 'identificationModule': {'nctId': 'NCT04528160', 'briefTitle': 'Pain Neuroscience Education for Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Aveiro University'}, 'officialTitle': 'Pain Neuroscience Education for Older Adults With Pain From Primary Care: a Feasibility Study', 'orgStudyIdInfo': {'id': 'PNE4OlderAdults'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain neuroscience education and exercise', 'description': 'This group will receive an 8-week intervention (1 session per week) of pain neuroscience education and exercise.\n\nPNE will be conducted in line with international guidelines and will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. Exercise will include mobility, balance and strength exercises.', 'interventionNames': ['Other: Pain neuroscience education and exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'This group will receive usual care administered by general practitioners at primary care.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Pain neuroscience education and exercise', 'type': 'OTHER', 'description': 'PNE will be conducted in line with international guidelines and will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. Exercise will included genera exercise delivered at moderate intensity.', 'armGroupLabels': ['Pain neuroscience education and exercise']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Usual care delivered at primary care for older adults with pain.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3810-193', 'city': 'Aveiro', 'country': 'Portugal', 'facility': 'School of Health Sciences', 'geoPoint': {'lat': 40.64575, 'lon': -8.64643}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aveiro University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Anabela G Silva', 'investigatorAffiliation': 'Aveiro University'}}}}