Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-27 @ 11:10 AM
Study NCT ID:
NCT07027059
Status:
RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Mobilization Exercises on Pain and Central Sensitization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-06-02', 'studyFirstSubmitQcDate': '2025-06-10', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central Sensitization', 'timeFrame': 'baseline and after the 8 sessions (4th week)', 'description': 'pressure pain threshold'}], 'secondaryOutcomes': [{'measure': 'Central Sensitization', 'timeFrame': 'baseline and after the 8 sessions (4th week)', 'description': 'Central Sensitization scale'}, {'measure': 'Pain Catastrophizing', 'timeFrame': 'baseline and after the 8 sessions (4th week)', 'description': 'Pain Catastrophizing scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lateral Epicondylitis'], 'conditions': ['Lateral Epicondylitis']}, 'referencesModule': {'references': [{'pmid': '26381484', 'type': 'BACKGROUND', 'citation': 'Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of neural mobilization exercises on central sensitization and pain characteristics in individuals with lateral epicondylitis. Enrolled participants will be randomly assigned to two groups. One group will receive routine exercises and ESWT treatment, while the other group will receive neural mobilization exercises in addition to routine exercises and ESWT treatment.', 'detailedDescription': 'This study aims to investigate the effects of neural mobilization exercises on central sensitization and pain characteristics in individuals with lateral epicondylitis. Enrolled participants will be randomly assigned to two groups. One group will receive routine exercises and ESWT treatment, while the other group will receive neural mobilization exercises in addition to routine exercises and ESWT treatment.\n\nMedian nerve mobilizations will be implemented as the neural mobilization exercises. All groups will receive two sessions per week and complete the process in four weeks; therefore, they will have received a total of eight sessions by the end of the study. Routine exercises and median nerve mobilizations will be implemented in every session (twice a week), while ESWT will be implemented once a week.\n\nMedian nerve mobilizations will be administered in 5 sets, each consisting of 10 repetitions per session.\n\nBefore and after the sessions, subjective factors related to pain will be assessed using the Central Sensitization Scale and the Pain Catastrophizing Scale, as well as pressure pain threshold measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of lateral epicondylitis\n* 18-65 years old\n\nExclusion Criteria:\n\nAny other pathology, disease, condition, pain, surgery on the elbow, wrist, fingers, shoulder, or neck in the last year'}, 'identificationModule': {'nctId': 'NCT07027059', 'briefTitle': 'Neural Mobilization Exercises on Pain and Central Sensitization', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Katip Celebi University'}, 'officialTitle': 'The Effect of Neural Mobilization Exercises on Pain and Central Sensitization in Individuals With Lateral Epicondylitis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Lepicondilitis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mobilization', 'description': 'participants will receive additional median nerve mobilizations', 'interventionNames': ['Behavioral: median nerve mobilization', 'Behavioral: routine exercises for lateral epicondylisits']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'participants will receive routine exercises', 'interventionNames': ['Behavioral: routine exercises for lateral epicondylisits']}], 'interventions': [{'name': 'median nerve mobilization', 'type': 'BEHAVIORAL', 'description': 'An exercise to increase median nerve mobility by flexing and extending fingers, wrist, elbow, shoulder, and neck', 'armGroupLabels': ['mobilization']}, {'name': 'routine exercises for lateral epicondylisits', 'type': 'BEHAVIORAL', 'description': 'eccentric strengthening exercises', 'armGroupLabels': ['control', 'mobilization']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'kevser kacmaz Kacmaz, PT, PhD', 'role': 'CONTACT', 'email': 'kevser_sevik@hotmail.com', 'phone': '505-550-9879'}, {'name': 'kevser sevik kacmaz, pt, phd', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Izmir Katip Celebi University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'kevser sevik kacmaz, pt, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izmir Katip Celebi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Katip Celebi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'research asisstant, phd', 'investigatorFullName': 'kevser kacmaz', 'investigatorAffiliation': 'Izmir Katip Celebi University'}}}}