Effectiveness of Acupuncture for Cervical Spondylotic Radiculopathy

NCT07150234 | Not Yet Recruiting

• 1 other identifier: 2025-109-KY-01
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

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

Keywords

cervical spondylotic radiculopathy

Outcome Measures

Primary Outcomes (1)

• Clinical response rate

  Average NRS (numerical rating scale) score of arm pain decreased by at least 30% compared with baseline in the past 24 hours.

  At 6 weeks from randomization.

Secondary Outcomes (15)

• The average NRS (numerical rating scale) score of arm pain in the past 24 hours as change from baseline.

  At 1,3,6,10,18,30 weeks from randomization.

• The average NRS (numerical rating scale) score of neck pain in the past 24 hours as change from baseline.

  At 1,3,6,10,18,30 weeks from randomization.

• Clinical response rate

  At 1,3,10,18,30 weeks from randomization.

• Clinical response rate

  At 1,3,6,10,18,30 weeks from randomization.

• The NDI (Neck Disability Index) score as change from baseline.

  At 3,6,10,18,30 weeks from randomization.

Other Outcomes (2)

• Assessment of belief in acupuncture

  Baseline assessment (week 0)

• Blinding assessment Description

  Within 5 minutes after either treatment at week 6.

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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).

Device: Acupuncture

Sham acupuncture group

SHAM COMPARATOR

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).

Device: sham acupuncture

Interventions

Acupuncture 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.

Acupuncture group

sham acupuncture 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.

Sham acupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is 18-75 years old;
• Patients meets the diagnostic criteria of cervical spondylotic radiculopathy and the discomfort such as pain and numbness only radiates to one upper limb (unilateral);
• NRS score of the average 24h arm pain/numbness in the last week was ≥4;
• The course of disease is ≥6 weeks;
• Patients voluntarily participate in the study and sign the informed consent.

You may not qualify if:

• 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.
• Those with diseases such as scapulohumeral periarthritis, thoracic outlet syndrome, tennis elbow, carpal tunnel syndrome, etc. that cause upper limb pain or discomfort;
• Those with cervical spondylotic radiculopathy whose condition is in a rapidly progressive stage;
• 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;
• Those with ankylosis of vertebral joints;
• Those neurological impairment (such as muscular atrophy and sensory disturbance);
• Those with congenital abnormality of cervical vertebra;
• Those with head and neck injuries and surgical history;
• Those with long-term use of analgesics, muscle relaxants, hormones, or other pain more severe than neck pain;
• Those with mental illness such as depression, anxiety, suicidal tendency, cognitive dysfunction or language disorder;
• Those who received acupuncture treatment one week before joining the group;
• Those who with drug dependence;
• 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;
• Those who are pregnant or planning pregnancy, lactating and postpartum ≤12 months within one year;
• Those who are metal allergy or serious needle fear;

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Access Criteria: A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal.