About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Acupuncture
DeviceThe 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
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
The average NRS (numerical rating scale) score of arm pain in the past 24 hours as change from baseline.
The average NRS (numerical rating scale) score of neck pain in the past 24 hours as change from baseline.
Clinical response rate
NRS (numerical rating scale) score of arm pain decreased by at least 30% compared with baseline in the past 24 hours.
Clinical response rate
NRS (numerical rating scale) score of neck pain decreased by at least 30% compared with baseline in the past 24 hours.
Other outcomes
Assessment of belief in acupuncture
Participants will be asked: Do you think your cervical spondylotic radiculopathy may be helped by acupuncture?
Blinding assessment Description
Participants will be asked: Do you think you have received traditional acupuncture in the past 6 weeks?
Locations
Sponsors and contacts
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