Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-31 @ 12:30 PM
Study NCT ID:
NCT05725356
Status:
UNKNOWN
Last Update Posted:
2023-02-13
First Post:
2023-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Physical Exercise on Chronic Non-Specific Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-02-09', 'lastUpdatePostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Pain Rating Scale', 'timeFrame': 'Change from baseline pain at 8 weeks', 'description': 'Used to assess pain intensity. It uses the numbers from 0 to 10 and 0 indicates (no pain) through 1-3 (mild pain, slight impairment in daily life activities), 4-6 (moderate pain, substantial impairment in daily life activities), and 7-10 (severe pain, severe impairment in daily life activities).'}, {'measure': 'Neck Disability Index', 'timeFrame': 'Change from baseline pain at 8 weeks', 'description': "Patient's self-reported impairment due to neck pain. It is a self-reported tool comprising 10 items. Each item is graded on a 6-point scale ranging from 0 (no disability) to 5 (severe disability)."}], 'secondaryOutcomes': [{'measure': 'Health and Safety Executive Management Standards Indicator Tool', 'timeFrame': 'Change from baseline pain at 8 weeks', 'description': "Assessing psychosocial stress in the work area. Thirty-five HSE-MS questions measure seven dimensions, including demands, control, supervisory support , peer support , relationships, role (including a clear understanding of the employee's role in the organization), and changes. A higher score on each dimension (5 points) indicated lower stress."}, {'measure': 'The Short Form Health Survey', 'timeFrame': 'Change from baseline pain at 8 weeks', 'description': 'Used to measure the quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'Neck pain is a common medical condition among office workers all over the world. The purpose of this study was to see if physical exercise, such as basic body awareness, neck-specific training exercises, and ergonomic modifications, could help reduce pain, disability, and job stress while also improving quality of life among office workers. Participants will be assigned at random to either an experimental (exercise therapy and ergonomic modification) or a control group (ergonomic modification).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 25-60 years\n* Greater than 3 months of chronic NSNP.\n* Office workers and computer users\n* The ability to continue working\n\nExclusion Criteria:\n\n* A history of severe injury\n* Previous physical therapy treatments\n* Joint instability\n* Frequent migraines\n* Spasmodic torticollis\n* Inflammatory rheumatic diseases\n* Peripheral nerve entrapment\n* Severe psychiatric illness\n* Pregnancy\n* Other conditions that prevent physical loading.'}, 'identificationModule': {'nctId': 'NCT05725356', 'briefTitle': 'Effectiveness of Physical Exercise on Chronic Non-Specific Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Qassim University'}, 'officialTitle': 'Effectiveness of Physical Exercise on Job Stress and Quality of Life in Office Workers With Chronic Non-Specific Neck Pain: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UT-153-31-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Receiving physical exercise treatment (basic body awareness therapy and neck-specific training exercises) and ergonomic modification', 'interventionNames': ['Other: Basic body awareness therapy']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Receiving ergonomic modification only', 'interventionNames': ['Other: Basic body awareness therapy']}], 'interventions': [{'name': 'Basic body awareness therapy', 'type': 'OTHER', 'otherNames': ['ergonomic modification'], 'description': 'Participants were instructed to focus on maintaining good posture, balance, uninterrupted breathing, increased awareness, and decreasing unnecessary muscle tension.', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buraidah', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Sattam Almutairi', 'role': 'CONTACT', 'phone': '0505102644'}], 'facility': 'King Fahad Specialist Hospital', 'geoPoint': {'lat': 26.32599, 'lon': 43.97497}}], 'centralContacts': [{'name': 'Sattam M Almutairi', 'role': 'CONTACT', 'email': 'A.Sattam@qu.edu.sa', 'phone': '+966505102644'}], 'overallOfficials': [{'name': 'Sattam M Almutairi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physical Therapy Department, College of Medical Rehabilitation Sciences, Qassim University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qassim University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tabuk', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Sattam Almutairi', 'investigatorAffiliation': 'Qassim University'}}}}