Effectiveness of Acupuncture for Cervical Spondylotic Radiculopathy

NCT ID: NCT07150234

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2028-09-30

Brief Summary

This study will be an evaluation of the efficacy and safety of acupuncture for cervical spondylotic radiculopathy. The main questions it aims to answer are 1. Does acupuncture improve the pain intensity among patients with cervical spondylotic radiculopathy? 2. Does acupuncture treat cervical spondylotic radiculopathy safely? Researchers will compare acupuncture to sham acupuncture to see if acupuncture could improve symptoms among patients with cervical spondylotic radiculopathy. Experimental and control groups will be treated with 6 weeks of acupuncture or sham-acupuncture respectively. Patients were followed up at 1 month, 3 months, 6 months after treatment to record outcome, any disease progression, adverse events, and so on.

Conditions

Cervical Spondylotic Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Acupuncture group

Acupuncture group received 3 acupuncture treatment sessions per week (every 1 or 2 days) over 6 weeks, 18 sessionsin total. The main acupuncture points are Jingbailao (EX-HN15), Jingjiaji (EX-B2), Binao (LI14) and Ashi. And according to the symptoms, select from the following acupoints: Wangu (GB12), Shouwuli (LI13), Quchi (LI11), Hegu (LI4), Zhongzhu (TE3) and Waiguan (TE5).

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: DEVICE

The needles will be inserted in acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes.

Sham acupuncture group

Sham acupuncture group received 3 sham acupuncture treatment sessions per week (every 1 or 2 days) over 6 weeks, 18 sessionsin total. The main acupuncture points are Jingbailao (EX-HN15), Jingjiaji (EX-B2), Binao (LI14) and Ashi. And according to the symptoms, select from the following acupoints: Wangu (GB12), Shouwuli (LI13), Quchi (LI11), Hegu (LI4), Zhongzhu (TE3) and Waiguan (TE5).

Group Type: SHAM_COMPARATOR

sham acupuncture

Intervention Type: DEVICE

The needles will be inserted into the pad and reaching the skin. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effect of the needle tip penetrating the skin.

Interventions

Acupuncture

The needles will be inserted in acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes.

Intervention Type: DEVICE

sham acupuncture

The needles will be inserted into the pad and reaching the skin. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effect of the needle tip penetrating the skin.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age is 18-75 years old;

2. Patients meets the diagnostic criteria of cervical spondylotic radiculopathy and the discomfort such as pain and numbness only radiates to one upper limb (unilateral);

3. NRS score of the average 24h arm pain/numbness in the last week was ≥4;

4. The course of disease is ≥6 weeks;

5. Patients voluntarily participate in the study and sign the informed consent.

Exclusion Criteria

1. Those with tumors, connective tissue diseases, rheumatism, spinal cord diseases, fractures, vertebral dislocation, metabolic and endocrine diseases (paget's disease, osteoporosis), other neuropathy (peripheral neuropathy, amyotrophic lateral sclerosis, transverse myelitis, Guillain-Barre syndrome, brachial plexus neuropathy), vascular related diseases (carotid artery dysfunction, arteriovenous fistula or deformity), inflammation(rheumatoid arthritis, inflammatory arthritis, ankylosing spondylitis) and infectious diseases (osteomyelitis, abscess, discitis, Lyme disease, herpes zoster, meningitis), etc.

2. Those with diseases such as scapulohumeral periarthritis, thoracic outlet syndrome, tennis elbow, carpal tunnel syndrome, etc. that cause upper limb pain or discomfort;

3. Those with cervical spondylotic radiculopathy whose condition is in a rapidly progressive stage;

4. Those received systematic comprehensive conservative treatment fails for three months, the conservative treatment includes physical therapy (fixation, traction, manipulation, exercise, ultrasound and infrared), drugs (ibuprofen, nonsteroidal anti-inflammatory drugs, gabapentin, pregabalin, antidepressants, etc.) and nerve block;

5. Those with ankylosis of vertebral joints;

6. Those neurological impairment (such as muscular atrophy and sensory disturbance);

7. Those with congenital abnormality of cervical vertebra;

8. Those with head and neck injuries and surgical history;

9. Those with long-term use of analgesics, muscle relaxants, hormones, or other pain more severe than neck pain;

10. Those with mental illness such as depression, anxiety, suicidal tendency, cognitive dysfunction or language disorder;

11. Those who received acupuncture treatment one week before joining the group;

12. Those who with drug dependence;

13. Those who with serious heart, liver, kidney, hematopoietic system, coagulation system, autoimmune system diseases, poorly controlled hypertension, diabetes, active infection, infectious diseases, severe malnutrition in the whole body, malignant tumor or serious diseases at the end stage;

14. Those who are pregnant or planning pregnancy, lactating and postpartum ≤12 months within one year;

15. Those who are metal allergy or serious needle fear;

16. Those with skin ulcer, damage and scar at selected acupoints;

17. Those who have received other clinical study within 90 days prior to randomization;

18. Pending litigation or industrial injury compensation related to neck pain;

19. Those who are unable to communicate in Mandarin or read Chinese.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Xinyu Shen

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2025-109-KY-01

Identifier Type: -

Identifier Source: org_study_id