Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-02-26 @ 7:16 PM
Study NCT ID:
NCT07241312
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Muscle Oxygenation and Upper Extremity Exercise Capacity in Patients With Chronic Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Trapezius Muscle Oxygen Saturation', 'timeFrame': 'Day 1', 'description': "Patients' trapezius muscle oxygen saturation will be measured using a near infrared spectroscopy (Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA))."}, {'measure': 'Evaluation of upper extremity capacity', 'timeFrame': 'Day 1', 'description': "Patients' upper extremity functional exercise capacity will be evaluated with six-minute pegboard and ring test."}], 'secondaryOutcomes': [{'measure': 'Evaluation of peripheral muscle strength', 'timeFrame': 'Day 2', 'description': "Patients' shoulder abductor and shoulder flexor, elbow flexor and upper trapezius muscle strength will be evaluated with a portable hand dynamometer (KFORCE Muscle Controller®, KinventTM, France)."}, {'measure': 'Evaluation of respiratory muscle strength', 'timeFrame': 'Day 2', 'description': 'An electronic mouth pressure device in accordance with American Thoracic Society and European Respiratory Society criteria will be used to evaluate respiratory muscle strength (Micro Medical MicroRM, UK).'}, {'measure': 'Evaluation of activity of daily living', 'timeFrame': 'Day 2', 'description': "The Glittre activity of daily living test will be used to evaluate patients' activities of daily living."}, {'measure': 'Evaluation of upper extremity functional status', 'timeFrame': 'Day 1', 'description': 'Upper Extremity Functional Index will be used to evaluate the upper extremity functional status of the patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic neck pain', 'upper extremity', 'muscle oxygenation'], 'conditions': ['Chronic Neck Pain']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to investigate the relationship between upper extremity exercise capacity and muscle oxygenation, muscle strength, and activities of daily living in patients with chronic neck pain.', 'detailedDescription': "Neck pain is an important public health problem that causes disability worldwide Chronic neck pain is defined as the presence of pain in an individual's neck area for more than twelve weeks. Chronic neck pain negatively affects the daily living activities of the individual; functional limitation causes job loss.\n\nNeck pain has been observed to be associated with the trapezius muscle and impaired microcirculation in the trapezius muscle and inadequate muscle blood flow and oxygenation.\n\nIn addition, neck pain has been stated to reduce upper extremity performance. However, most of the results regarding the relationship between muscle activity and pain are not consistent. In addition, there are studies showing that respiratory muscles as well as peripheral muscles are affected in these patients. In the light of all this information, it was concluded that there may be a relationship between upper extremity exercise capacity and the oxygen level of the trapezius muscle and activities of daily living in patients with chronic neck pain. In this context, the aim of the study was to investigate the relationship between upper extremity exercise capacity and muscle oxygenation, muscle strength and activities of daily living in patients with chronic neck pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between the ages of 18-65 who have had neck pain for at least 12 weeks, who were followed up in the Physical Therapy Outpatient Clinic of the Department of Physical Medicine and Rehabilitation will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with neck pain lasting at least 3 months due to one of the following problems: cervical strain or sprain, cervical disc lesions, cervical spondylosis, facet joint dysfunction, and myofascial pain syndrome.\n\nExclusion Criteria:\n\n* Neck pain intensity during activity is below 3 points according to the Visual Analog Scale\n* Upper extremity motor deficit on neurological examination\n* Any surgery related to neck problems\n* Cervical radiculopathy\n* Any upper extremity surgery\n* Any rheumatic and/or neurological disease or any disease affecting the vestibular system'}, 'identificationModule': {'nctId': 'NCT07241312', 'briefTitle': 'Relationship Between Muscle Oxygenation and Upper Extremity Exercise Capacity in Patients With Chronic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Kirsehir Ahi Evran Universitesi'}, 'officialTitle': 'Investigation of the Relationship Between Muscle Oxygenation and Upper Extremity Exercise Capacity, Respiratory and Peripheral Muscle Strength, and Activities of Daily Living in Patients With Chronic Neck Pain', 'orgStudyIdInfo': {'id': 'AhiEvranU530'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Neck Pain Group', 'description': 'Individuals between the ages of 18-65 who have had neck pain for at least 12 weeks, who were followed up in the Physical Therapy Outpatient Clinic of the Department of Physical Medicine and Rehabilitation will be included in the study.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kırşehir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Kırşehir Ahi Evran University, Physical Therapy and Rehabilitation Center, Cardiopulmonary Unit', 'geoPoint': {'lat': 39.14583, 'lon': 34.16389}}], 'centralContacts': [{'name': 'Başak KAVALCI KOL, PhD', 'role': 'CONTACT', 'email': 'basak.kavalci@ahievran.edu.tr', 'phone': '+903862802317'}], 'overallOfficials': [{'name': 'Başak KAVALCI KOL, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kirsehir Ahi Evran Universitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirsehir Ahi Evran Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D, Lecturer', 'investigatorFullName': 'Başak KAVALCI KOL', 'investigatorAffiliation': 'Kirsehir Ahi Evran Universitesi'}}}}