Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-01-20 @ 7:02 AM
Study NCT ID:
NCT06485804
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI Mobile App vs Self Exercises in Workers With Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gender', 'timeFrame': 'Assessed at baseline', 'description': 'Gender: Female, Male.'}, {'measure': 'Age', 'timeFrame': 'Assessed at baseline', 'description': 'Age in terms of years'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Assessed at baseline', 'description': "BMI is calculated as follows: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height (in metres) squared."}, {'measure': 'Comorbidities', 'timeFrame': 'Assessed at baseline', 'description': 'Comorbidities comprise: Diabetes, Hypertension, Thyroid disorders, Cardiovascular and Lung diseases, and Cancer history.'}, {'measure': 'Musculoskeletal disorders', 'timeFrame': 'Assessed at baseline', 'description': 'Musculoskeletal disorders comprise: Osteoarthrities, Rheumatic arthritis, Osteoporosis, and Tendinopathies.'}, {'measure': 'Work seniority', 'timeFrame': 'Assessed at baseline', 'description': 'Work seniority: Length of work service (years).'}, {'measure': 'Time spent in front of computer', 'timeFrame': 'Assessed at baseline', 'description': 'Time spent in front of computer: average number of daily hours spent in front of computer.'}], 'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Pain intensity will be assessed at baseline, and at 4, and 8 weeks of follow-up.', 'description': 'Pain intensity assessed using a Visual Analog Scale on a scale from 0 to 100.'}], 'secondaryOutcomes': [{'measure': 'Function', 'timeFrame': 'Function will be assessed at baseline, and at 4, and 8 weeks of follow-up.', 'description': 'Patient function will be assessed using the neck disability index (NDI). The scale consists of a set of questions addressing various aspects of neck pain and its influence on activities such as personal care, lifting, reading, working, and recreation'}, {'measure': 'Quality of life measure', 'timeFrame': 'Quality of life will be assessed at baseline, and at 4, and 8 weeks of follow-up.', 'description': "The short form 12 (SF-12) will be used to measure health-related Quality of life. The SF-12 is a shorter version of the short form 36 (SF-36) and is used to assess individual's physical and mental well-being."}, {'measure': 'Patient adherence', 'timeFrame': 'Patient adherence will be assessed at 4, and 8 weeks of follow-up.', 'description': 'Adherence will be measured using a frequency-based response scale (ie; never, seldom, often, almost always, and always) adapted from the adherence scale of Sluijs et al. (Phys Ther 1993)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Office Workers', 'Clinical trial Protocol', 'Exercise Therapy', 'Mobile Application', 'Neck Pain', 'Patient compliance', 'Self-management', 'Workplace'], 'conditions': ['Neck Pain', 'Work-Related Condition']}, 'referencesModule': {'references': [{'pmid': '40971708', 'type': 'DERIVED', 'citation': 'Salah S, Jellad A, Mili M, Chaabeni A, Bedoui MH, Ben Saad H. Comparing efficacy and adherence of smartphone-guided exercises to conventional self-directed exercises for neck pain in office workers: A randomized controlled trial protocol. PLoS One. 2025 Sep 19;20(9):e0329863. doi: 10.1371/journal.pone.0329863. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the impact of two different methods to administer self-exercises in administrative workers with neck pain: an Artificial Intelligence embedded mobile application and written sheet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '63 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The presence of a chronic NP lasting for more than three months, and a pain level at baseline assessment ≥ 30 (VAS)\n\nExclusion Criteria:\n\n* Acute neck pain, neck pain from specific causes (eg; Chronic inflammatory diseases), spine trauma or surgery, cervical radiculopathy or myelopathy, and physical therapy treatments in the last six months before baseline assessment.'}, 'identificationModule': {'nctId': 'NCT06485804', 'briefTitle': 'AI Mobile App vs Self Exercises in Workers With Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Comparing Efficacy and Adherence of Smartphone-guided Exercises to Conventional Self-directed Exercises for Neck Pain in Office Workers: A Randomized Controlled Trial Protocol', 'orgStudyIdInfo': {'id': 'AIMobApp-Neck-Pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants in the intervention group will use a smartphone application which will provide an individualized exercises program.', 'interventionNames': ['Other: Smartphone application guided exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants in the control group will receive a rehabilitation program delivered on a paper sheet containing pictures of exercises with written explanations in French, including the number of sets and repetitions'}], 'interventions': [{'name': 'Smartphone application guided exercises', 'type': 'OTHER', 'description': 'Participants in the intervention group will use a smartphone application to execute a self-rehabilitation program. The app will integrate:\n\n* Basic information about neck pain and ergonomic advice.\n* A series of evaluation questions on pain and function.\n* Appropriate sets of exercises with videos and instructions.\n* Daily reminders.\n* Evaluation reports providing feedback and adherence.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Anis Jellad, Professor', 'role': 'CONTACT', 'email': 'anisjellad@gmail.com', 'phone': '98210626'}], 'overallOfficials': [{'name': 'Sana Salah, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Monastir'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sana Salah', 'class': 'UNKNOWN'}, {'name': 'Amr Chaabeni', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anis Jellad', 'investigatorAffiliation': 'University of Monastir'}}}}