Effectiveness of Acupuncture for Cervical Spondylotic Radiculopathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Acupuncture groupExperimental treatment 1 intervention
Group B: Sham acupuncture groupSham comparator 1 intervention

Trial outcomes

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.

Time frame
At 6 weeks from randomization.

Secondary outcomes

1

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

Time frame
At 1,3,6,10,18,30 weeks from randomization.
2

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

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

Clinical response rate

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

Time frame
At 1,3,10,18,30 weeks from randomization.
4

Clinical response rate

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

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

Other outcomes

1

Assessment of belief in acupuncture

Participants will be asked: Do you think your cervical spondylotic radiculopathy may be helped by acupuncture?

Time frame
Baseline assessment (week 0)
2

Blinding assessment Description

Participants will be asked: Do you think you have received traditional acupuncture in the past 6 weeks?

Time frame
Within 5 minutes after either treatment at week 6.

Locations

This trial has no locations.

Sponsors and contacts

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