Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-29 @ 6:52 AM
Study NCT ID:
NCT05077566
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2021-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'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': 'D010101', 'term': 'Oxygen Consumption'}], 'ancestors': [{'id': 'D008660', 'term': 'Metabolism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure pain threshold', 'timeFrame': 'Baseline', 'description': 'Pressure pain threshold measured with an algometer in Kgf'}, {'measure': 'Pressure pain threshold', 'timeFrame': 'Post-intervention (approximately 45 minutes after baseline)', 'description': 'Pressure pain threshold measured with an algometer in Kgf'}], 'secondaryOutcomes': [{'measure': 'Aerobic capacity', 'timeFrame': 'Baseline', 'description': 'Measured with the Chester Step Test (CST) which gives aerobic capacity and allows the calculation of percentage of VO2 max.'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline', 'description': 'Measured with the International Physical Activity Questionnaire. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week).'}, {'measure': 'Anxiety and depression', 'timeFrame': 'Baseline', 'description': 'Measured with the Hospital Anxiety and Depression Scale. This scale has 2 subscales, one for Anxiety and one for Depression both scored 0 to 21 and higher values represent higher levels of anxiety and depression.'}, {'measure': 'Catastrophizing', 'timeFrame': 'Baseline', 'description': 'Measured with the Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)'}, {'measure': 'Fear of movement', 'timeFrame': 'Baseline', 'description': 'Measured with the TAMPA Scale of Kinesiophobia (range: 13-52 and higher values are indicative of higher levels of fear of movement)'}, {'measure': 'Disability', 'timeFrame': 'Base', 'description': 'Measured with the Roland Morris Disability Questionnaire (range: 0 to 24, with higher values indicating higher disability)'}, {'measure': 'Pain phenotype', 'timeFrame': 'Baseline', 'description': 'Measured with the Pain DETECT Scale. The final score between -1 and 38, indicates the likelihood of a neuropathic pain component. A score of ) 12 indicates that pain is unlikely to have a neuropathic component (\\< 15%), while a score of \\* 19 suggests that pain is likely to have a neuropathic component (\\> 90%).'}, {'measure': 'Symptoms of central sensitization', 'timeFrame': 'Baseline', 'description': 'Measured with the Central Sensitization Inventory. Score ranges from 0 to 100 and higher scores indicate higher symptoms of central sensitization.'}, {'measure': 'Pain intensity', 'timeFrame': 'Baseline', 'description': 'Assessed using the Visual Analogue Scale from 0 to 100 mm'}, {'measure': 'Pain intensity', 'timeFrame': 'Post-intervention (approximately 45 minutes after baseline)', 'description': 'Assessed using the Visual Analogue Scale from 0 to 100 mm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is:\n\n• To evaluate the immediate hypoalgesic effect of an aerobic exercise session of different intensities in patients with chronic low back pain;\n\nThe secondary objective is:\n\n• To explore whether pain intensity, level of physical activity, functionality, catastrophizing, kinesiophobia, anxiety and depression interfere with the immediate hypoalgesic effect of exercise.', 'detailedDescription': 'There will be 3 groups of participants, an asymptomatic control group that will not perform any exercise and two groups of individuals with low back pain. One group will perform exercise at 90% VO2máx and the other at 60% VO2máx.\n\nAll the three groups will be assessed at baseline for pressure pain threshold, pain intensity, pain phenotype, disability, kinesiophobia, catastrophizing, anxiety and depression, physical activity, and aerobic capacity. In addition, pressure pain threshold and pain intensity will also be assessed at post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All groups:\n* age between 18 and 65 years old\n* Participants with low back pain:\n* non-specific LBP (defined as pain between the costal margins and the inferior gluteal folds, which is usually accompanied by painful limitation of movement and may be associated with pain referred down to the leg)\n\nExclusion Criteria:\n\n* All groups:\n* presence of pathology of the nervous system, cardiovascular or carcinogenic, rheumatic diseases (for example, rheumatoid arthritis), fibromyalgia, previous history of lumbar surgery, medication that affects or alters heart rate, any contraindication to exercise and pregnancy.'}, 'identificationModule': {'nctId': 'NCT05077566', 'briefTitle': 'Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Aveiro University'}, 'officialTitle': 'Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'CED8_2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise at 60% vo2', 'description': 'This arm will receive 15 minutes of exercise at 60% VO2 max.', 'interventionNames': ['Other: Exercise at 60% vo2']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise at 90% vo2', 'description': 'This arm will receive 15 minutes of exercise at 90% VO2 max.', 'interventionNames': ['Other: Exercise at 90% vo2']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'No intervention'}], 'interventions': [{'name': 'Exercise at 60% vo2', 'type': 'OTHER', 'description': '15 minutes of exercise at 60% VO2 max.', 'armGroupLabels': ['Exercise at 60% vo2']}, {'name': 'Exercise at 90% vo2', 'type': 'OTHER', 'description': '15 minutes of exercise at 90% VO2 max.', 'armGroupLabels': ['Exercise at 90% vo2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aveiro', 'country': 'Portugal', 'facility': 'Private Clinics of Physiotherapy', 'geoPoint': {'lat': 40.64575, 'lon': -8.64643}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aveiro University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Anabela G Silva', 'investigatorAffiliation': 'Aveiro University'}}}}