Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 5:46 PM
Study NCT ID:
NCT07368751
Status:
RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-01-20', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the Shoulder Pain and Disability Index (SPADI) at weeks 6 and 12.', 'timeFrame': 'Change from baseline in SPADI score at weeks 6 and 12', 'description': 'The Shoulder Pain and Disability Index (SPADI) will be used to assess shoulder pain and disability levels in patients. SPADI consists of 13 items and includes two subscales: pain and disability. The pain subscale consists of 5 items while the disability subscale consists of 8 items. Both subscale scores and the total score are calculated on a 0-100 scale, with higher scores indicating greater pain and disability.'}, {'measure': 'Change from baseline of Numerical Rating Pain Scale (NPRS) at week 6 and week 12', 'timeFrame': 'Change from baseline in NPRS score at week 6 and week 12', 'description': 'Pain intensity will be assessed using the Numerical Rating Pain Scale (NPRS). Participants will be asked to rate the intensity of their shoulder pain on a scale from 0 to 10, with higher scores indicating greater pain.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) score at week 6 and week 12', 'timeFrame': 'Change from baseline in QuickDASH score at weeks 6 and 12', 'description': 'QuickDASH is a patient-reported outcome measure and will be used to assess upper extremity function and symptoms. The total score ranges from 0 to 100, with higher scores indicating greater functional disability.'}, {'measure': 'Change from baseline in Pain Catastrophizing Scale (PCS) score at week 6 and week 12', 'timeFrame': 'Change from baseline in PCS score at weeks 6 and 12', 'description': 'The Pain Catastrophizing Scale (PCS) will be used to assess rumination, magnification, and helplessness related to pain. The scale yields a total score ranging from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.'}, {'measure': 'change from baseline in the Glenohumeral Joint Range of Motion at week 6 and week 12', 'timeFrame': 'Change from baseline in range of motion at weeks 6 and 12', 'description': 'Glenohumeral joint range of motion will be assessed using a universal goniometer, a widely used and reliable method for measuring shoulder joint mobility.'}, {'measure': 'Change from baseline in Pain Self-Efficacy Questionnaire (PSEQ) score at week 6 and week 12', 'timeFrame': 'Change from baseline in PSEQ score at weeks 6 and 12', 'description': "The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item self-report questionnaire designed to assess an individual's confidence in performing activities despite pain. Total scores range from 0 to 60, with higher scores indicating greater pain-related self-efficacy."}, {'measure': 'Treatment satisfaction assessed with the Global Rating of Change (GRC) Scale at weeks 6 and 12', 'timeFrame': 'At weeks 6 and 12', 'description': "GRC scale is designed to measure a patient's perceived improvement or deterioration over time to determine the effect of an intervention. A 5-point scale ranging from -2 to +2 will be used (-2 = much worse, -1 = worse, 0 = no change, +1 = better, +2 = much better)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frozen Shoulder', 'Vagus Nerve Stimulation', 'Exercise'], 'conditions': ['Frozen Shoulder']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if the addition of transcutaneous vagus nerve stimulation (tVNS) to exercise is effective in improving pain, shoulder function, shoulder range of motion, and psychological factors in adults with frozen shoulder.\n\nThe main questions this study aims to answer are:\n\nDoes adding tVNS to exercise reduce shoulder pain ? Does adding tVNS to exercise improve shoulder function and shoulder range of motion? Does adding tVNS to exercise improve psychological factors ? Does adding tVNS to exercise improve patient satisfaction?\n\nResearchers will compare the effect of active tVNS added to exercise with sham-controlled tVNS added to exercise to determine whether adding tVNS provides additional benefits in the management of frozen shoulder.\n\nParticipants will:\n\nReceive active tVNS plus exercise therapy or sham-controlled tVNS plus exercise therapy.\n\nAttend supervised rehabilitation sessions 3 times per week for 6 weeks. Perform a home exercise program as instructed by the study physiotherapist.', 'detailedDescription': 'This is a randomized, double-blind (participants and outcome assessors), sham-controlled study. Participants will be recruited from a university hospital. Volunteers diagnosed with frozen shoulder who meet the inclusion criteria and are referred by an orthopedics and traumatology specialist will be included.\n\nThe study will be conducted in accordance with the ethical principles of the Declaration of Helsinki. Participants who provide written informed consent and meet the inclusion criteria will be randomized in a 1:1 ratio to either exercise therapy combined with active transcutaneous Vagus Nerve Stimulation (tVNS) or exercise therapy combined with sham-controlled tVNS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 40 and 65 years.\n* Less than 50% range of motion compared with the contralateral shoulder in at least one movement (external rotation, abduction, flexion, or internal rotation).\n* More than 25% loss of range of motion in at least two movement planes compared with the unaffected shoulder.\n* Increasing limitation of glenohumeral external and internal rotation during abduction from 45° to 90°.\n* Shoulder pain lasting at least 3 months during activities of daily living.\n\nExclusion Criteria:\n\n* Passive joint range of motion within normal limits\n* External rotation range of motion \\<30°\n* Radiographic evidence of glenohumeral arthritis\n* Presence of inflammatory joint disease\n* Previous treatment related to the current shoulder complaint (physiotherapy and rehabilitation, intra-articular injection, or surgery)\n* Pain intensity \\<3 according to the Numerical Pain Rating Scale (NPRS)\n* Presence of neurological deficits, cardiac disease, neuropathic disorders, or pregnancy'}, 'identificationModule': {'nctId': 'NCT07368751', 'briefTitle': 'Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Clinical Effects of Transcutaneous Vagus Nerve Stimulation in the Treatment of Frozen Shoulder: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IUC-FTR-SA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'transcutaneous Vagus Nerve Stimulation (tVNS) plus exercises', 'description': 'the interventional group will receive active tVNS plus exercise therapy including traditional exercises and home exercises.', 'interventionNames': ['Other: Active tVNS plus exercises']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham controlled tVNS plus exercises', 'description': 'the control group will receive Sham-controlled tVNS plus exercise therapy including traditional exercises and home exercises.', 'interventionNames': ['Other: Sham controlled tVNS plus exercises']}], 'interventions': [{'name': 'Active tVNS plus exercises', 'type': 'OTHER', 'description': 'This program will be performed 3 times per week for 6 weeks. Each session will include 30 minutes of tVNS. Stimulation will be delivered to the auricular branch of the vagus nerve using a non-invasive transcutaneous device. Electrodes will be placed on the tragus and concha regions of the ear. in addition to traditional exercises including mobilization, ROM exercises, stretching and strengthening exercises.', 'armGroupLabels': ['transcutaneous Vagus Nerve Stimulation (tVNS) plus exercises']}, {'name': 'Sham controlled tVNS plus exercises', 'type': 'OTHER', 'description': 'This program will be performed three times per week for six weeks. In each session, 30 minutes of sham tVNS will be applied, during which the device will remain inactive, in addition to traditional exercise therapy including joint mobilization, range of motion exercises, stretching, and strengthening exercises.', 'armGroupLabels': ['Sham controlled tVNS plus exercises']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Salam Alruz, Msc', 'role': 'CONTACT', 'email': 'salamalruz@gmail.com', 'phone': '+90 5510805265'}, {'name': 'Derya Çelik', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Istanbul University-Cerrahpaşa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Salam Alruz, MSc', 'role': 'CONTACT', 'email': 'salamalruz@gmail.com', 'phone': '+90 5510805265'}], 'overallOfficials': [{'name': 'Salam Alruz, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Salam Alruz', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}