Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT03804567
Status:
COMPLETED
Last Update Posted:
2020-04-10
First Post:
2019-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oldpain2go®: an Exploratory (Pre-Feasibility) Study.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-09', 'studyFirstSubmitDate': '2019-01-11', 'studyFirstSubmitQcDate': '2019-01-11', 'lastUpdatePostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A 100mm pain intensity Visual Analogue Scale (VAS) for low back pain', 'timeFrame': 'Change measures at three points, baseline, 1 week and 2 weeks from baseline', 'description': 'A self reported pain level scale'}], 'secondaryOutcomes': [{'measure': 'The Roland Morris Disability Questionnaire (RMDQ)', 'timeFrame': 'Change measures at three points, baseline, 1 week and 2 weeks from baseline', 'description': 'A measure of disability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oldpain2go®', 'Feasibility'], 'conditions': ['Pain, Chronic']}, 'descriptionModule': {'briefSummary': 'Research question: Is there any evidence to suggest that the oldpain2go® intervention merits scientific investigation?', 'detailedDescription': 'Aims:\n\n1. To collect data to:\n\n 1. give an indication of the potential effect size, of any effects, from the oldpain2go® intervention, in people with persistent low back pain.\n 2. to explore the eligibility criteria, recruitment methods and materials proposed here, for potential use in a future Feasibility study, of the oldpain2go® intervention.\n2. To compare demographic characteristics, medical history and outcome measure data of:\n\n 1. people for whom Oldpain2go® is indicated (at the Oldpain2go® screening session), with those for whom it is not,\n 2. people for whom the Oldpain2go® intervention works, after one treatment, with those for whom it does not, and\n 3. people for whom the Oldpain2go® intervention works, after one, or two, treatments, with those for whom it does not work after two treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently suffering from persistent, non-specific, low back pain\n* Aged over 18 years\n* For whom Oldpain2go® is indicated as a treatment option after the standard clinical screening process for the Oldpain2go® treatment\n\nExclusion Criteria:\n\n* Any Red Flags,\n* Any causative (or potentially causative) structural abnormality, or pathology detected or suspected\n* Any concurrent pathology, or condition that would limit options for Physiotherapy treatment,\n* Lack of (or any reason to doubt presence of) Mental Capacity to give Informed Consent'}, 'identificationModule': {'nctId': 'NCT03804567', 'acronym': 'Oldpain2go®', 'briefTitle': 'Oldpain2go®: an Exploratory (Pre-Feasibility) Study.', 'organization': {'class': 'OTHER', 'fullName': 'Teesside University'}, 'officialTitle': 'Oldpain2go®: an Exploratory (Pre-Feasibility) Study.', 'orgStudyIdInfo': {'id': '163/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oldpain2go®', 'description': 'This is a concept of dealing with a client in a way that uses their conscious mind to alter their unconscious automated programs (chronic pain) that are troubling them.', 'interventionNames': ['Other: Oldpain2go®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine low back pain management', 'description': 'Normal accepted physiotherapy treatment for persistent low back pain.', 'interventionNames': ['Other: Routine low back pain management']}], 'interventions': [{'name': 'Oldpain2go®', 'type': 'OTHER', 'description': 'This is a concept of dealing with a client in a way that uses their conscious mind to alter their unconscious automated programs such as chronic pain that are troubling them.', 'armGroupLabels': ['Oldpain2go®']}, {'name': 'Routine low back pain management', 'type': 'OTHER', 'description': 'Standard low back persistent physiotherapy management as recommended by national guidelines.', 'armGroupLabels': ['Routine low back pain management']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TS20 2PT', 'city': 'Norton', 'state': 'Stockton-on-Tees', 'country': 'United Kingdom', 'facility': 'Norton Physiotherapy Centre', 'geoPoint': {'lat': 54.13303, 'lon': -0.78501}}], 'overallOfficials': [{'name': 'Alasdair MacSween, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Teesside University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teesside University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Lecturer in Research Governance', 'investigatorFullName': 'Alasdair MacSween', 'investigatorAffiliation': 'Teesside University'}}}}