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| ID | Type | Description | Link |
|---|---|---|---|
| 86/QĐ-ĐHQG | Other Grant/Funding Number | Vietnam National University, Ho Chi Minh City |
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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.
This 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.
A 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.
The findings will provide clinical evidence on the effectiveness of acupuncture at Lieque (LU7) for reducing neck pain and improving patient outcomes in cervical spondylosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lieque (LU7) + Electroacupuncture | Experimental | 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). |
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| Electroacupuncture Only | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture at LU7 (Lieque) + Electroacupuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neck Pain Intensity (VAS Score) | 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. | Baseline (D0), Day 10 (D10), and Day 20 (D20). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neck Pain Questionnaire (NPQ) Score | 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 | Description | Time Frame |
|---|---|---|
| Adverse Events Related to Acupuncture/Electroacupuncture | 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. | Throughout the 20 treatment sessions (approximately 4 weeks). |
Inclusion Criteria:
Age 40 years or older
Diagnosis of cervical spondylosis based on clinical evaluation and imaging.
Presence of cervical spine syndrome, including:
Radiographic evidence of cervical spondylosis on standard X-ray (frontal, lateral, or oblique views), showing one or more of the following:
Patients receiving treatment at Thu Duc City Hospital
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ngoc Doan Thuy Nguyen, MD, MSc | Contact | +84-918-949-394 | nndthuy@uhsvnu.edu.vn | |
| Ngoc Doan Thuy Nguyen, MD, MSc | Contact | +84-918-949-394 | nguyenngocdoanthuy@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Ngoc Doan Thuy Nguyen, MD, MSc | The University of Health Sciences, VNU-HCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thu Duc City Hospital | Ho Chi Minh City | Ho Chi Minh | 700000 | Vietnam |
Individual participant data will not be shared due to concerns regarding data confidentiality and patient privacy.
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| ID | Term |
|---|---|
| D055009 | Spondylosis |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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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.
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| Electroacupuncture Only | Procedure | 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. |
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| Baseline (D0), Day 10 (D10), and Day 20 (D20). |
| Change in Cervical Range of Motion (ROM) | 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. | Baseline (D0), Day 10 (D10), and Day 20 (D20). |
| Distribution of Traditional Chinese Medicine (TCM) Syndrome Types | Participants will be classified into Traditional Chinese Medicine (TCM) syndromes according to TCM diagnostic criteria: Wind-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. | At baseline (D0), prior to intervention. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |