Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-30 @ 3:05 PM
Study NCT ID:
NCT06270069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-02-13', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS', 'timeFrame': 'Immediately before the rehab treatment starts and immediately after the intervention', 'description': 'Numerical Rating Scale; score 0-10 with higher estimates indicating higher levels of pain intensity (horizontal line)'}, {'measure': 'Gauge of pain', 'timeFrame': 'Immediately before the rehab treatment starts and immediately after the intervention', 'description': 'Numerical Rating Scale; score -5/+5 with lower estimates indicating higher levels of pain intensity (vertical line)'}], 'secondaryOutcomes': [{'measure': 'ODI', 'timeFrame': 'Immediately before the rehab treatment starts and immediately after the intervention', 'description': 'Oswestry Disability Index; score 0-50 with higher scores representing greater restriction to activities.'}, {'measure': 'PCS', 'timeFrame': 'Immediately before the rehab treatment starts and immediately after the intervention', 'description': 'Pain Catastrophizing Scale; score 0-52 with higher estimates showing higher catastrophizing'}, {'measure': 'TSK', 'timeFrame': 'Immediately before the rehab treatment starts and immediately after the intervention', 'description': 'Tampa Scale of Kinesiophobia; score 13-52 with higher estimates showing higher fear of movement'}, {'measure': 'PSEQ', 'timeFrame': 'Immediately before the rehab treatment starts and immediately after the intervention', 'description': 'Pain Self Efficacy Questionnaire; score 0-60 with higher estimates showing higher self-effficacy'}, {'measure': 'GPE', 'timeFrame': 'Immediately after the intervention', 'description': 'Global Perceived Effect (how much did the treatment received help your pain?); score -3 (it worsen a lot the things)/+3 (it helped a lot)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This is an observational study aimed at evaluating the responsiveness and minimal important change of two measures of pain intensity in people with low back pain. It consists of a battery of self-administered questionnaires which will be given to individuals with low back pain to complete before and after a rehabilitation treatment. Relationships among the different outcome measures will be also evaluated.', 'detailedDescription': 'This is an observational study aimed at evaluating the responsiveness and minimal important change of two different graphical ways to assess pain intensity in people with low back pain.\n\nLiterature found out that low back pain intensity is commonly assessed by a numerical rating scale ranging from no pain to the worst imaginable pain, once presented to responders horizontally. A different way to assess pain intensity could be to answer a similar numerical rating scale if set vertically.\n\nIn Literature there are not studies which head-to-head evaluate the responsiveness and minimal important change of these two ways of assessing pain intensity due to low back pain.\n\nParticipants will also have to complete self-reported outcome measures of disability, catastrophizing, fear of movement and self-efficacy, and correlations among these tools and the above two different ways to evaluate pain intensity will be evaluated. Descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample under investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Non-specific low back pain is defined as low back pain not attributable to a recognizable, known specific pathology (eg, infection, tumour, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder,radicular syndrome, or cauda equina syndrome).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non specific low back pain\n* Adult age\n* Ability to understand the Italian language\n\nExclusion Criteria:\n\n* Refuse to adhere to the study\n* Definite causes of low back pain\n* Central or peripheral neurological signs\n* Systemic illness or psychiatric deficits\n* Recent myocardial infarction, cerebrovascular events, or chronic lung or renal diseases'}, 'identificationModule': {'nctId': 'NCT06270069', 'briefTitle': 'Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'International Institute of Behavioral Medicines'}, 'officialTitle': 'Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain', 'orgStudyIdInfo': {'id': '2024-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Excercise-based therapy', 'type': 'OTHER', 'description': 'An individual 60-min motor training sessions twice a week for eight-week outpatient program, that included exercises aimed at improving postural control, strengthening and stabilizing the back muscles, and stretching'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Barbara Rocca, MSC', 'role': 'CONTACT', 'email': 'info.ellis.bm@gmail.com', 'phone': '3333653393'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Institute of Behavioral Medicines', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}