Cervical Spondylotic RadiculopathyNCT07150234
Effectiveness of Acupuncture for Cervical Spondylotic Radiculopathy
A study testing Acupuncture in people with Cervical Spondylotic Radiculopathy, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Spondylotic Radiculopathy
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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;
- Those with skin ulcer, damage and scar at selected acupoints;
- Those who have received other clinical study within 90 days prior to randomization;
- Pending litigation or industrial injury compensation related to neck pain;
- Those who are unable to communicate in Mandarin or read Chinese.
About this study
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
- Being tested
- Acupuncture, sham acupuncture
- Keywords
- cervical spondylotic radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
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 acupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At 1,3,6,10,18,30 weeks from randomization.
Clinical response rate
NRS (numerical rating scale) score of arm pain decreased by at least 30% compared with baseline in the past 24 hours.
Measured: At 1,3,10,18,30 weeks from randomization.
Clinical response rate
NRS (numerical rating scale) score of neck pain decreased by at least 30% compared with baseline in the past 24 hours.
Measured: At 1,3,6,10,18,30 weeks from randomization.
The NDI (Neck Disability Index) score as change from baseline.
Measured: At 3,6,10,18,30 weeks from randomization.
Percentage of patients with NDI (Neck Disability Index) score lower than baseline by 8.5 points or more.
Measured: At 3,6,10,18,30 weeks from randomization.
NRS (numerical rating scale) score of the maximum neck/arm pain during neck exercise as change from baseline.
Measured: At 1,3,6,10,18,30 week from randomization.
ISI-C (Insomnia Severity Index) score as change from baseline.
Measured: At 6,10,18,30 weeks from randomization.
PHQ-9 (Patient Health Questionnaire-9) score as change from baseline.
Measured: At 3,6,10,18,30 weeks from randomization.
GAD-7 (Generalized Anxiety Disorder-7) score as change from baseline.
Measured: At 3,6,10,18,30 weeks from randomization.
EQ-5D-5L score as change from baseline.
Measured: At 6,10,18,30 weeks from randomization.
Patient Global Impression of Change, PGIC
1 means great improvement of arm pain, 2 means moderate improvement of arm pain, 3 means better of arm pain, 4 means no change of arm pain, 5 means slight deterioration of arm pain, 6 means moderate deterioration of arm pain and 7 means much deterioration of arm pain.
Measured: At 6,30 weeks from randomization.
Percentage of emergency painkillers used in the past week.
Measured: At 1,3,6,10,18,30 weeks from randomization.
The total number of days of using emergency painkillers in the past week.
Measured: At 1,3,6,10,18,30 weeks from randomization.
Adverse event
Collect the adverse reactions related to acupuncture, such as needle breakage, local hematoma, infection and abscess, and any unexpected symptoms, signs or health conditions during the experiment.
Measured: At 1,3,6,10,18,30 weeks from randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start10 Sep 2025 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spondylotic RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Shen, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150234
- Sponsor's protocol ID
- 2025-109-KY-01
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data and data dictionary will be available with the publication until six months after publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupuncture for Cervical Spondylotic Radiculopathy
- ClinicalTrials.gov ID
- NCT07150234
- Acronym / sponsor ID
- 2025-109-KY-01
- Conditions
- Cervical Spondylotic Radiculopathy
- Keywords
- cervical spondylotic radiculopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 10 Sep 2025 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Device: AcupunctureAcupuncture 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). |
| Sham acupuncture group | Sham comparator | Device: sham acupunctureSham 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureThe 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. | Device | Acupuncture group |
| sham acupunctureThe 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. | Device | Sham acupuncture group |
Primary outcome
Clinical response rate
Time frame: At 6 weeks from randomization.
Average NRS (numerical rating scale) score of arm pain decreased by at least 30% compared with baseline in the past 24 hours.
15 secondary outcomes
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.
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.
Clinical response rate
Time frame: At 1,3,10,18,30 weeks from randomization.
Clinical response rate
Time frame: At 1,3,6,10,18,30 weeks from randomization.
The NDI (Neck Disability Index) score as change from baseline.
Time frame: At 3,6,10,18,30 weeks from randomization.
Percentage of patients with NDI (Neck Disability Index) score lower than baseline by 8.5 points or more.
Time frame: At 3,6,10,18,30 weeks from randomization.
NRS (numerical rating scale) score of the maximum neck/arm pain during neck exercise as change from baseline.
Time frame: At 1,3,6,10,18,30 week from randomization.
ISI-C (Insomnia Severity Index) score as change from baseline.
Time frame: At 6,10,18,30 weeks from randomization.
PHQ-9 (Patient Health Questionnaire-9) score as change from baseline.
Time frame: At 3,6,10,18,30 weeks from randomization.
GAD-7 (Generalized Anxiety Disorder-7) score as change from baseline.
Time frame: At 3,6,10,18,30 weeks from randomization.
EQ-5D-5L score as change from baseline.
Time frame: At 6,10,18,30 weeks from randomization.
Patient Global Impression of Change, PGIC
Time frame: At 6,30 weeks from randomization.
Percentage of emergency painkillers used in the past week.
Time frame: At 1,3,6,10,18,30 weeks from randomization.
The total number of days of using emergency painkillers in the past week.
Time frame: At 1,3,6,10,18,30 weeks from randomization.
Adverse event
Time frame: At 1,3,6,10,18,30 weeks from randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: Yes. Deidentified participant data and data dictionary will be available with the publication until six months after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Cervical Spondylotic Radiculopathy, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate (time frame: At 6 weeks from randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.