Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-10 @ 1:58 PM
Study NCT ID:
NCT07151404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Acupuncture at Lieque (LU7) for Neck Pain in Cervical Spondylosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'D015671', 'term': 'Electroacupuncture'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to two groups. The experimental group will receive filiform needle acupuncture at Lieque (LU7) combined with electroacupuncture at Jiaji (Ex-B2, C4-C7) and selected neck-shoulder acupoints. The control group will receive electroacupuncture at Jiaji (Ex-B2, C4-C7) and neck-shoulder acupoints only. Treatment will be performed once daily for a total of 20 sessions over approximately 4 weeks, excluding Sundays.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events Related to Acupuncture/Electroacupuncture', 'timeFrame': 'Throughout the 20 treatment sessions (approximately 4 weeks).', 'description': 'All adverse events will be systematically recorded, including but not limited to: nausea, fatigue, dizziness, heavy numbness of the limbs, and other unexpected events. Each event will be assessed for severity (mild, moderate, severe) and its possible relationship to the intervention.'}, {'measure': 'Distribution of Traditional Chinese Medicine (TCM) Syndrome Types', 'timeFrame': 'At baseline (D0), prior to intervention.', 'description': 'Participants will be classified into Traditional Chinese Medicine (TCM) syndromes according to TCM diagnostic criteria:\n\nWind-Cold-Damp Bi Syndrome (WCDBS) Wind-Damp-Heat Bi Syndrome (WDHBS) Qi Stagnation and Blood Stasis (QSBS) Liver and Kidney Yin Deficiency (LKYD) The frequency and proportion of each syndrome type will be recorded.'}], 'primaryOutcomes': [{'measure': 'Change in Neck Pain Intensity (VAS Score)', 'timeFrame': 'Baseline (D0), Day 10 (D10), and Day 20 (D20).', 'description': 'Pain intensity in the neck region will be assessed using a 100-mm Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain.'}], 'secondaryOutcomes': [{'measure': 'Change in Neck Pain Questionnaire (NPQ) Score', 'timeFrame': 'Baseline (D0), Day 10 (D10), and Day 20 (D20).', 'description': 'The NPQ (8-item version) will be used to assess disability related to neck pain. It covers 8 domains: pain intensity, pain and sleep, nocturnal paresthesia, duration of symptoms, carrying objects, reading/TV, work/housework, and social activities. Each domain is scored 0-4; total score ranges from 0 (no disability) to 32 (severe disability). Higher scores indicate greater disability.'}, {'measure': 'Change in Cervical Range of Motion (ROM)', 'timeFrame': 'Baseline (D0), Day 10 (D10), and Day 20 (D20).', 'description': 'Cervical spine ROM (flexion, extension, right/left lateral flexion, right/left rotation) will be measured in degrees using a goniometer (or inclinometer). Higher values indicate greater mobility.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical Spondylosis', 'Neck Pain', 'Cervical Spine', 'Acupuncture', 'Electroacupuncture', 'Lieque Point', 'LU7 Acupoint', 'Jiaji Points', 'Cervical-Shoulder Acupoints', 'Randomized Controlled Trial', 'LU7', 'Ex-B2', 'Ex-B2, C4-C7'], 'conditions': ['Cervical Spondylosis', 'Neck Pain']}, 'descriptionModule': {'briefSummary': 'Cervical spondylosis is a common degenerative disorder of the cervical spine that often leads to chronic neck pain, stiffness, and reduced daily functioning. Pain management in these patients remains challenging, and acupuncture is widely used as a non-pharmacological treatment option. However, the additional benefit of stimulating the Lieque (LU7) acupoint, based on the Six Command Points theory, has not been fully established.\n\nThis randomized controlled trial will evaluate whether acupuncture at Lieque (LU7), combined with electroacupuncture at Jiaji (Ex-B2, C4-C7) and cervical-shoulder points, provides greater pain relief compared to electroacupuncture at Jiaji (Ex-B2, C4-C7) and cervical-shoulder points alone.\n\nA total of 130 participants with cervical spondylosis will be randomly assigned to two groups. Treatments will be delivered over 20 days. The primary outcome is the change in neck pain intensity, measured by a 0-100 mm Visual Analog Scale (VAS), from baseline to the end of treatment.\n\nThe findings will provide clinical evidence on the effectiveness of acupuncture at Lieque (LU7) for reducing neck pain and improving patient outcomes in cervical spondylosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40 years or older\n* Diagnosis of cervical spondylosis based on clinical evaluation and imaging.\n* Presence of cervical spine syndrome, including:\n\n * Neck and shoulder pain.\n * Limited range of motion in the cervical spine.\n * Local tenderness over the cervical spine or paraspinal region corresponding to nerve roots.\n* Radiographic evidence of cervical spondylosis on standard X-ray (frontal, lateral, or oblique views), showing one or more of the following:\n\n * Subchondral sclerosis.\n * Narrowing of the intervertebral disc space.\n * Osteophyte formation (bone spurs, bridging osteophytes).\n* Patients receiving treatment at Thu Duc City Hospital\n\nExclusion Criteria:\n\n* Patients who do not agree to participate in the study.\n* Acute torticollis, cervical disc herniation, spinal deformity, cervical spine trauma, or spinal tumors.\n* Neck and shoulder pain not caused by cervical spondylosis.\n* History of systemic diseases such as rheumatoid arthritis, severe cardiovascular disease, systemic infection, malignancy, or immunodeficiency disorders.\n* History of neurological or psychiatric conditions that impair communication or compliance, including speech disorders, impaired consciousness, psychosis, or dementia.\n* Contraindications to electroacupuncture.\n* Non-compliance with study treatment protocol.\n* Use of non-steroidal anti-inflammatory drugs (NSAIDs) within the past 10 days or local corticosteroid injection within the past 3 months.'}, 'identificationModule': {'nctId': 'NCT07151404', 'briefTitle': 'Efficacy of Acupuncture at Lieque (LU7) for Neck Pain in Cervical Spondylosis', 'organization': {'class': 'OTHER', 'fullName': 'School of Medicine - Vietnam National University at Ho Chi Minh city'}, 'officialTitle': 'Efficacy of Acupuncture at Lieque (LU7) Based on Six Command Points Theory, Combined With Electroacupuncture at Jiaji (Ex-B2, C4-C7) and Cervical-Shoulder Points in Cervical Spondylosis', 'orgStudyIdInfo': {'id': 'C2025-44-13'}, 'secondaryIdInfos': [{'id': '86/QĐ-ĐHQG', 'type': 'OTHER_GRANT', 'domain': 'Vietnam National University, Ho Chi Minh City'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lieque (LU7) + Electroacupuncture', 'description': 'Participants will receive filiform needle acupuncture at Lieque (LU7) combined with electroacupuncture at Jiaji (Ex-B2, C4-C7) and neck-shoulder acupoints. Sterile disposable filiform needles (0.3 × 25 mm) will be used. Electroacupuncture will be applied at 60 Hz continuous wave for 30 minutes per session. Treatment will be given once daily for a total of 20 sessions, excluding Sundays (approximately 4 weeks).', 'interventionNames': ['Procedure: Acupuncture at LU7 (Lieque) + Electroacupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Electroacupuncture Only', 'description': 'Participants will receive electroacupuncture at Jiaji (Ex-B2, C4-C7) and neck-shoulder acupoints only, without acupuncture at Lieque (LU7). Electroacupuncture will be applied at 60 Hz continuous wave for 30 minutes per session. Treatment will be given once daily for a total of 20 sessions, excluding Sundays (approximately 4 weeks).', 'interventionNames': ['Procedure: Electroacupuncture Only']}], 'interventions': [{'name': 'Acupuncture at LU7 (Lieque) + Electroacupuncture', 'type': 'PROCEDURE', 'otherNames': ['Filiform Needle Acupuncture at Lieque (LU7)', 'Filiform Needle Acupuncture at LU7', 'Filiform Needle Acupuncture'], 'description': 'Participants will receive filiform needle acupuncture at Lieque (LU7) combined with electroacupuncture at Jiaji (Ex-B2, C4-C7) and neck-shoulder acupoints including Fengchi (GB20), Jianjing (GB21), Tianzhu (BL10), and Dazhu (BL11). Sterile disposable filiform needles (0.3 × 25 mm) will be inserted at LU7 using standard manual acupuncture technique. Electroacupuncture will be delivered with continuous wave stimulation at 60 Hz for 30 minutes per session. Treatment will be performed once daily for a total of 20 sessions over approximately 4 weeks, excluding Sundays.', 'armGroupLabels': ['Lieque (LU7) + Electroacupuncture']}, {'name': 'Electroacupuncture Only', 'type': 'PROCEDURE', 'otherNames': ['Electroacupuncture', 'Electroacupuncture Control', 'EA at Jiaji and Neck-Shoulder Acupoints', 'EA', 'Electroacupuncture at Jiaji and Neck-Shoulder Acupoints'], 'description': 'Participants will receive electroacupuncture at Jiaji (Ex-B2, C4-C7) and neck-shoulder acupoints including Fengchi (GB20), Jianjing (GB21), Tianzhu (BL10), and Dazhu (BL11), without acupuncture at Lieque (LU7). Electroacupuncture will be delivered with continuous wave stimulation at 60 Hz for 30 minutes per session. Treatment will be performed once daily for a total of 20 sessions over approximately 4 weeks, excluding Sundays.', 'armGroupLabels': ['Electroacupuncture Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700000', 'city': 'Ho Chi Minh City', 'state': 'Ho Chi Minh', 'country': 'Vietnam', 'contacts': [{'name': 'Ngoc Doan Thuy Nguyen, MD, MSc', 'role': 'CONTACT', 'email': 'nndthuy@uhsvnu.edu.vn', 'phone': '+84-918-949-394'}, {'name': 'Ngoc Doan Thuy Nguyen, MD, MSc', 'role': 'CONTACT', 'email': 'nguyenngocdoanthuy@outlook.com', 'phone': '+84-918-949-394'}, {'name': 'Ngoc Doan Thuy Nguyen, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xuan Sy Truong, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Van Dinh Le, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Thu Duc City Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'centralContacts': [{'name': 'Ngoc Doan Thuy Nguyen, MD, MSc', 'role': 'CONTACT', 'email': 'nndthuy@uhsvnu.edu.vn', 'phone': '+84-918-949-394'}, {'name': 'Ngoc Doan Thuy Nguyen, MD, MSc', 'role': 'CONTACT', 'email': 'nguyenngocdoanthuy@outlook.com', 'phone': '+84-918-949-394'}], 'overallOfficials': [{'name': 'Ngoc Doan Thuy Nguyen, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Health Sciences, Vietnam National University Ho Chi Minh City'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to concerns regarding data confidentiality and patient privacy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nguyen Ngoc Doan Thuy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MSc, MD, Lecturer, Department of Acupuncture, School of Medicine - Vietnam National University at Ho Chi Minh City', 'investigatorFullName': 'Nguyen Ngoc Doan Thuy', 'investigatorAffiliation': 'School of Medicine - Vietnam National University at Ho Chi Minh city'}}}}