Cervical SpondylopathyNCT06847945
Observation on the Curative Effect of Acupuncture At Sensitized Points on Gallbladder Meridian in the Treatment of Neck Type Cervical Spondylopathy
A study testing Acupuncture in people with Cervical Spondylopathy, run by LiChaoran at 1 site in China.
Trial summary
To investigate the changes of acupoint sensitization characteristics of patients with Neck Type Cervical Spondylopathy through Gallbladder meridian observe the curative effect of acupuncture intervention and optimize the clinical diagnosis and treatment plan of acupuncture treatment of Neck Type Cervical Spondylopathy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Spondylopathy
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2025to 31 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting the diagnostic criteria of Neck Type Cervical Spondylopathy.
- Age 18 to 65 years old gender is not limited.
- Clear awareness good compliance willing to cooperate with the study and accept the experimental arrangement.
- Physical examination may or may not be accompanied by positive signs of the musculoskeletal system (including limited motor function local tender points etc.).
- The visual analogue Scale (VAS) score was more than 3 points and less than 7 points (ranging from 0 to 10 points).
- Informed consent and sign informed consent.
Who cannot join
- It does not meet the diagnostic criteria and inclusion criteria of cervical spondylosis.
- Under 18 years of age or over 65 years of age;
- 2 weeks before the start of the experiment the relevant treatment of the disease or the use of relevant therapeutic drugs;
- Patients with other types of cervical spondylosis (cervical radiculopathy vertebral artery type cervical spondylosis cervical myelopathy sympathetic cervical spondylosis) or with other serious organic diseases and patients with neck and shoulder pain caused by non-neck diseases;
- Patients with cardiovascular and cerebrovascular liver kidney digestive system blood system and other serious life-threatening primary diseases or suffering from hemorrhagic diseases or skin diseases or pregnant or lactating women or have a history of cardiac pacemaker implantation;
- Previous history of neck surgery or neck fracture;
- Persons with confusion mental disorder or cognitive impairment;
- The skin at the test site has scars redness swelling heat and pain that affect the test result.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third Affiliated Hospital of Zhejiang Chinese Medicine University
Hangzhou, 310000
15557137527
About this study
Official title: Changes of Acupoint Sensitization Characteristics on Gallbladder Meridian and Acupuncture Intervention Effect in Patients with Cervical Spondylosis
To investigate the changes of acupoint sensitization characteristics of patients with Neck Type Cervical Spondylopathy through Gallbladder meridian observe the curative effect of acupuncture intervention and optimize the clinical diagnosis and treatment plan of acupuncture treatment of Neck Type Cervical Spondylopathy
- Conditions
- Cervical Spondylopathy
- Being tested
- Sham acupuncture, Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham acupunctureProcedure or surgery
Patients in the non-meridian and non-acupoint group received sham acupuncture treatment at the position 2cm apart from the sensitized acupoint, once every other day for 30min each time, a total of 3 times for 1 week.
AcupunctureProcedure or surgery
Patients in acupoint sensitization group were treated with pseudoacupuncture at the sensitized points once every other day for 30min each time, a total of 3 times for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Non-meridian，non-acupoint group | Sham comparator | Not described Receives: Procedure: Sham acupuncture |
| Acupoint sensitization group | Experimental | Not described Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The visual Analogue Scale (VAS) ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function of the Cervical. Participants were asked to evaluate their current pain, and the pain nature was marked by X on the line above. 0 was classified as painless and 10 was classified as severe pain. The higher the score, the more obvious the pain.
Measured: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up
Secondary outcomes (5)
musculoskeletal ultrasound detection of cervical
Measured: Before the start of treatment, immediately after the end of the third treatment
Pressure pain threshold
The measurement result of FDX Force Gauge can quantify pain more objectively in clinical practice. And pressure pain threshold(PPT) at acupoints can be measured more objectively and accurately by FDX Force Gauge. The tester used a hand-held pain threshold test instrument to probe the acupoints.After switching on the machine, the comp peak mode was selected. The unit of measurement result is N.The figure on the display was zeroed before each measurement. The probe (1cm in diameter) was placed vertically on the acupoints of Gallbladder meridian. And the pressure was applied slowly and steadily at a constant speed(at a rate of 5N/s) downwards, and stopped immediately when the subject started to feel pain.The figure on the display is the pain threshold of the acupoint.Every acupoint was measured twice, with a 5-minute break between each measurement session.
Measured: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up
The Neck Disability Index
The NDI consists of 10 items that cover various aspects of daily life affected by neck pain, including pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreational activities.Each item is scored on a scale from 0 to 5, where 0 indicates no disability and 5 represents the worst imaginable disability. The total score ranges from 0 to 50, which can also be expressed as a percentage by multiplying the raw score by 2.
Interpretation of the scores is as follows:
0-4: No disability 5-14: Mild disability 15-24: Moderate disability 25-34: Severe disability Over 34: Complete disability
Measured: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up
Cervical range of motion scale
Subjects take a seated position, head in the middle, shoulders relaxed, both eyes looking straight ahead, forward flexion: normal flexion range of mition is between 35 °and 45 °; backward extension: the normal degree of backward extension is between 35 ° and 45 °; lateral flexion: normal lateral flexion range of mition is 45 °; rotate:the normal degree of rotation is between 60°and 80°. A range of motion instrument (Digital Angle Ruler)will be used to determine cervical spine movements. The device will be placed on the top or side of the head and the patient will be instructed to move the head as far as possible, without experiencing pain, in a standard fashion;right rotation, left rotation, flexion, extension, right lateral flexion and left lateral flexion. Within the range of cervical motion of patients, a larger value indicates a healthier cervical spine, while a smaller value indicates a more serious cervical mobility disorder.
Measured: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up
The 12 items Short Form Health Survey
The 12-Item Short Form Health Survey (SF-12) is a widely used tool designed to assess overall health-related quality of life. It evaluates both physical and mental health domains through 12 questions, providing two composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).Scoring Range:Minimum Score: 0，Maximum Score: 100.Higher Scores: Indicate better health status. Higher PCS and MCS scores suggest better physical and mental well-being, respectively.Lower Scores: Indicate worse health status. Lower scores may suggest significant limitations in daily activities or poorer psychological well-being.
Measured: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start5 Mar 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical SpondylopathyStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LiChaoran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LiChaoran, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Chaoran Li, Study chair, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847945
- Sponsor's protocol ID
- ZSLL-KY-2023-040-03
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li C, Wang J, Shao X, Wu Y, Qu X, Cai J, He L, Yu L, Xu R, Xia Y, Wang R, Zhang L, Qiu Y. Acupuncture at Sensitized Acupoints versus Sham Acupuncture for Neck-Type Cervical Spondylosis: Study Protocol for a Randomized Controlled Trial. J Pain Res. 2025 Dec 23;18:6963-6976. doi: 10.2147/JPR.S548317. eCollection 2025.
PubMed 41458188
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Acupoint Sensitization Characteristics on Gallbladder Meridian and Acupuncture Intervention Effect in Patients with Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT06847945
- Acronym / sponsor ID
- ZSLL-KY-2023-040-03
- Conditions
- Cervical Spondylopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- LiChaoranUniversity, hospital or other
- Study start
- 5 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Feb 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.
To investigate the changes of acupoint sensitization characteristics of patients with Neck Type Cervical Spondylopathy through Gallbladder meridian observe the curative effect of acupuncture intervention and optimize the clinical diagnosis and treatment plan of acupuncture treatment of Neck Type Cervical Spondylopathy
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 |
|---|---|---|
| Non-meridian，non-acupoint group | Sham comparator | Procedure: Sham acupuncture |
| Acupoint sensitization group | Experimental | Procedure: Acupuncture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meeting the diagnostic criteria of Neck Type Cervical Spondylopathy.
- Age 18 to 65 years old gender is not limited.
- Clear awareness good compliance willing to cooperate with the study and accept the experimental arrangement.
- Physical examination may or may not be accompanied by positive signs of the musculoskeletal system (including limited motor function local tender points etc.).
- The visual analogue Scale (VAS) score was more than 3 points and less than 7 points (ranging from 0 to 10 points).
Key exclusion criteria (8 listed)
- It does not meet the diagnostic criteria and inclusion criteria of cervical spondylosis.
- Under 18 years of age or over 65 years of age;
- 2 weeks before the start of the experiment the relevant treatment of the disease or the use of relevant therapeutic drugs;
- Patients with other types of cervical spondylosis (cervical radiculopathy vertebral artery type cervical spondylosis cervical myelopathy sympathetic cervical spondylosis) or with other serious organic diseases and patients with neck and shoulder pain caused by non-neck diseases;
- Patients with cardiovascular and cerebrovascular liver kidney digestive system blood system and other serious life-threatening primary diseases or suffering from hemorrhagic diseases or skin diseases or pregnant or lactating women or have a history of cardiac pacemaker implantation;
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 |
|---|---|---|
| Sham acupuncturePatients in the non-meridian and non-acupoint group received sham acupuncture treatment at the position 2cm apart from the sensitized acupoint, once every other day for 30min each time, a total of 3 times for 1 week. | Procedure or surgery | Non-meridian，non-acupoint group |
| AcupuncturePatients in acupoint sensitization group were treated with pseudoacupuncture at the sensitized points once every other day for 30min each time, a total of 3 times for 1 week. | Procedure or surgery | Acupoint sensitization group |
Primary outcome
Visual Analogue Scale
Time frame: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up
The visual Analogue Scale (VAS) ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function of the Cervical. Participants were asked to evaluate their current pain, and the pain nature was marked by X on the line above. 0 was classified as painless and 10 was classified as severe pain. The higher the score, the more obvious the pain.
5 secondary outcomes
musculoskeletal ultrasound detection of cervical
Time frame: Before the start of treatment, immediately after the end of the third treatment
Pressure pain threshold
Time frame: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up
The Neck Disability Index
Time frame: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up
Cervical range of motion scale
Time frame: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up
The 12 items Short Form Health Survey
Time frame: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up
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 26 Feb 2025.
- Derived from this study: PubMed 41458188Li C, Wang J, Shao X, Wu Y, Qu X, Cai J, He L, Yu L, Xu R, Xia Y, Wang R, Zhang L, Qiu Y. Acupuncture at Sensitized Acupoints versus Sham Acupuncture for Neck-Type Cervical Spondylosis: Study Protocol for a Randomized Controlled Trial. J Pain Res. 2025 Dec 23;18:6963-6976. doi: 10.2147/JPR.S548317. eCollection 2025.
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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.
Chaoran Li study chair
The Third Affiliated hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Cervical Spondylopathy, run by LiChaoran at 1 site in China.
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 6 inclusion and 8 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 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Chaoran Li (15557137527, crwd44@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06847945, which also lists 1 linked publication.
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 26 Feb 2025.