Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-29 @ 1:55 AM
Study NCT ID:
NCT06649903
Status:
COMPLETED
Last Update Posted:
2024-11-04
First Post:
2024-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Spinal Manipulation and Visteral Osteopathy for Mechanical 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026882', 'term': 'Manipulation, Chiropractic'}, {'id': 'D055360', 'term': 'Osteopathic Physicians'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010820', 'term': 'Physicians'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'It is a randomized controlled study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-01', 'studyFirstSubmitDate': '2024-10-17', 'studyFirstSubmitQcDate': '2024-10-17', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS pain scale', 'timeFrame': 'At baseline and immediately following the intervention session.', 'description': 'The Visual Analog Scale (VAS) for pain is a subjective measurement tool used to assess an individual\\'s pain intensity. It consists of a straight line, typically 10 centimeters in length, with endpoints that represent the extremes of pain: one end signifies \\"no pain\\" (0) and the other indicates \\"worst pain imaginable\\" (10).\n\nParticipants mark a point on the line that corresponds to their pain level at the moment of assessment. The distance from the \\"no pain\\" end to the marked point is then measured in centimeters, providing a numerical value that quantifies the intensity of the pain experienced. This scale is commonly used in clinical settings for its simplicity and effectiveness in capturing the subjective experience of pain.'}, {'measure': 'Microfet 2 Dynamometer', 'timeFrame': 'At baseline and immediately following the intervention session.', 'description': 'The Microfet 2 Dynamometer is a handheld device used to objectively measure muscle strength in clinical and research settings. It employs a digital force transducer that provides accurate and reliable assessments of isometric muscle strength across various muscle groups.\n\nIt is commonly used in physical therapy and rehabilitation to evaluate muscle function, track progress over time, and inform treatment decisions. Its compact size and versatility make it suitable for various assessments, including grip strength, limb strength, and specific muscle testing. The device is particularly valuable for ensuring standardized measurements in strength evaluation protocols.'}], 'secondaryOutcomes': [{'measure': 'Hand Dynamometer', 'timeFrame': 'At baseline and immediately following the intervention session.', 'description': 'A hand dynamometer is a electronic device used to measure grip strength, which is an important indicator of overall muscle strength and function.\n\nThe hand dynamometer is widely used in clinical, rehabilitation, and research settings to assess the strength of the hand and forearm muscles. This measurement can provide valuable information regarding a patient\\'s recovery progress, functional capacity, and overall health status.\n\nConsistent use of the hand dynamometer can help establish baselines, track changes in muscle strength over time, and guide treatment interventions for various conditions affecting hand function.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neck pain treatment', 'visceral osteopathy', 'servical spinal manupilation', 'osteopathy'], 'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'This study compares two treatment techniques, cervical spinal manipulation (CSM) and visceral osteopathy (VO), in patients with mechanical neck pain (MNP). The aim of the study was to evaluate the effects of these treatments on pain levels, neck mobility, and muscle strength in both the neck and upper extremities.', 'detailedDescription': 'The purpose of this study is to compare the acute effects of cervical spinal manipulation (CSM) treatment and visceral osteopathy (VO) techniques on pain, cervical range of motion (ROM), muscle strength, and grip strength in individuals with mechanical neck pain (MNP).\n\nThe study is going to include a total of 30 subjects aged 18-60 diagnosed with MNP. The subjects are randomly divided into two groups. The CSM group received high-velocity, low-amplitude (HVLA) spinal manipulation, while the other group underwent VO techniques. Each treatment technique is going to be applied in only one session. Pain intensity is assessed using the Visual Analog Scale (VAS). Cervical ROM and the craniovertebral angle (CVA) are evaluated using a goniometer. Neck and elbow muscle strength are measured with a hand-held dynamometer, and grip strength is assessed using a hand-grip dynamometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants is included if they had neck pain present for at least one week, reduced cervical ROM, a manual muscle test score of 4 or higher for the neck muscles, and no neurological pain in the neck.\n\nExclusion Criteria:\n\n* Exclusion criteria included individuals with rheumatic diseases, a history of spinal surgery, neck fractures, tumors in the neck region, vertebrobasilar artery insufficiency, blood clotting disorders, or inadequate mental capacity.'}, 'identificationModule': {'nctId': 'NCT06649903', 'briefTitle': 'Cervical Spinal Manipulation and Visteral Osteopathy for Mechanical Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Atlas University'}, 'officialTitle': 'Comparison of Cervical Spinal Manipulation and Visceral Osteopathy Techniques in People with Mechanical Neck Pain', 'orgStudyIdInfo': {'id': 'Cihat Seyrek'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervical Spinal Manipulation (CSM)', 'description': 'This arm includes participants who receive a single session of high-velocity, low-amplitude spinal manipulation aimed at reducing pain and improving cervical range of motion and muscle strength in individuals with mechanical neck pain. The intervention is administered by a qualified physiotherapist, following established protocols for cervical spinal manipulation.', 'interventionNames': ['Behavioral: Chiropractic']}, {'type': 'EXPERIMENTAL', 'label': 'Visceral Osteopathy', 'description': 'Participants in this arm undergo a single session of visceral osteopathy techniques focused on improving pain and functional outcomes in individuals with mechanical neck pain. The VO techniques are designed to enhance mobility and alleviate discomfort through manipulation of the viscera and associated structures, performed by a trained osteopath.', 'interventionNames': ['Behavioral: Osteopathy']}], 'interventions': [{'name': 'Chiropractic', 'type': 'BEHAVIORAL', 'description': 'high speed low amplitude neck manipulation', 'armGroupLabels': ['Cervical Spinal Manipulation (CSM)']}, {'name': 'Osteopathy', 'type': 'BEHAVIORAL', 'description': 'the stomach and liver technique was applied', 'armGroupLabels': ['Visceral Osteopathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34408, 34403', 'city': 'Istanbul', 'state': 'Kagıthane', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Atlas University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34413', 'city': 'Istanbul', 'state': 'Kağıthane', 'country': 'Turkey (Türkiye)', 'facility': 'Atlas University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'At this time, we are undecided about sharing individual participant data (IPD) with other researchers. We will evaluate the feasibility and ethical considerations of data sharing upon study completion. Factors influencing this decision may include participant confidentiality, data integrity, and potential research collaborations. A final determination will be made based on these considerations to ensure compliance with ethical guidelines and the responsible use of participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlas University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Hilal Denizoğlu Külli', 'investigatorAffiliation': 'Atlas University'}}}}