Chronic Neck PainNCT07892495
The Clinical Efficacy and Multimodal Imaging Mechanism of the Knot-tying Technique in the Treatment of Chronic Neck Pain
A study testing Untangling Needle Therapy: Acupuncture with Untangling Needle in people with Chronic Neck Pain, run by Li Juntao.
Trial summary
This study is a multicenter 1:1 randomized controlled trial, enrolling patients with chronic neck pain from the Rehabilitation Medicine Department of Huizhou Third People's Hospital. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Untangling Needle Therapy: Acupuncture with Untangling Needle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2028
- Phase
- Interventional
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for chronic neck pain;
- Aged 20-65, any gender;
- Experienced neck pain in the past 7 days and complain of neck pain and limited range of motion; ④ Diagnosed with chronic neck pain at their medical institution or another healthcare facility; ⑤ Have at least one active myofascial trigger point (MTrP) in the unilateral trapezius area; ⑥ Voluntarily choose to participate in this study and sign the informed consent form; ⑦ Visual analog scale (VAS) score ≥3 at rest;
Who cannot join
- Took medication or received treatment for neck or shoulder muscle pain or discomfort in the past 7 days;
- Have a history of neck surgery in the past 3 months;
- Suffered a neck sprain from trauma such as a traffic accident or contusion in the past 3 months;
- Have cervical radiculopathy, cervical disc herniation, spinal canal stenosis, fracture, dislocation, infection, tuberculosis, tumor, rheumatic autoimmune disease, spinal cord lesions, or severe neurological deficits;
- Have acute soft tissue injury, related rheumatic diseases, congenital cervical deformities, psychogenic pain, or suspected/confirmed vertebral or spinal canal tumors, tuberculosis, or severe osteoporosis; ⑥ Have severe heart (or has a pacemaker), liver, kidney, cerebrovascular, tumor diseases, or other conditions the researchers consider unsuitable for participation;
- ⑦ (Females only) Have been pregnant or given birth in the past 6 months;
- ⑧ Participated in other clinical intervention studies in the past 3 months;
- ⑨ Other individuals deemed unsuitable for the study by medical staff, such as those with impaired cognitive function who cannot understand the consent form or provide voluntary consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Efficacy and Multimodal Imaging Mechanisms of Jiejie Acupuncture for Chronic Neck Pain
This study is a multicenter 1:1 randomized controlled trial, enrolling patients with chronic neck pain from the Rehabilitation Medicine Department of Huizhou Third People's Hospital. A total of 60 participants are planned to be recruited, divided 1:1 into a trial group receiving the knot-release acupuncture method and a sham acupuncture control group. The study aims to evaluate the immediate clinical efficacy and safety of the knot-release acupuncture method for treating chronic neck pain and to explore its peripheral-to-central mechanisms using multimodal detection technologies. The research content includes:
- Dynamically monitoring core evaluation indicators in enrolled patients, including VAS scores, real-time shear wave elastography (SWE), cervical range of motion (ROM), Neck Disability Index (NDI-TH), and functional near-infrared spectroscopy (fNIRS), to assess the immediate clinical efficacy and safety of the knot-release acupuncture method for chronic neck pain.
- Observing and recording any adverse events throughout the intervention period, systematically and scientifically evaluating the clinical safety of the knot-release acupuncture method for chronic neck pain, and providing a safety basis for its standardized clinical application.
- Conditions
- Chronic Neck Pain
- Being tested
- Untangling Needle Therapy: Acupuncture with Untangling Needle, Sham acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Untangling Needle Therapy: Acupuncture with Untangling NeedleOther
Use acupuncture needles on the trigger points to provoke and relax them, once a day, 3-5 minutes each time, for a total of one treatment.
Sham acupunctureOther
Sham acupuncture, using needles of the same specifications for shallow insertion at trigger points. Treatment frequency: shallow insertion depth of 3mm, once a day, 3-5 minutes each time, for a total of 1 treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: JieJie Needle Therapy: needling with JieJie needles | Experimental | Unknotting Needling Treatment: Acupuncture with an unknotting needle Treatment Frequency: Use the acupuncture needle on the trigger point to provoke and release the knot, once a day, 3-5 minutes each time, for a total of 1 session Receives: Other: Untangling Needle Therapy: Acupuncture with Untangling Needle |
| Control group: sham acupuncture | Sham comparator | Sham acupuncture, using needles of the same specification for shallow insertion at trigger points. Treatment frequency: shallow insertion depth of 3mm, once a day, 3-5 minutes each time, for a total of 1 treatment. Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale（VAS）
- Score range: 0-10 points
- 0 points: no pain
- 10 points: the most severe pain imaginable
- Meaning of the score: the higher the score, the more intense the pain (worse)
Measured: Baseline, immediately after treatment
Trapezius shear modulus measured by a soft tissue mechanical imager using real-time shear wave elastography (SWE) technology and 2D ultrasound qualitative imaging features
Using a soft tissue mechanical imaging device, we employ real-time shear wave elastography (SWE) to detect active myofascial trigger points (MTrPs) in the upper trapezius. Participants sit or lie face down, with their head and elbows fixed in position. The upper trapezius MTrPs are located using standardized palpation methods. The probe is coated with 4 mm of coupling gel and gently placed on the skin, avoiding the fascia layer in the measurement scale, with a 5 mm gap between the excitation handle and the probe marker. For each measurement point, 10 sets of data are collected, and values with a relative error of less than 10% are considered valid. The median of these valid values is taken as the shear modulus result. During the measurement process, 2D ultrasound images of the target area are also collected, and the assessor qualitatively records the 2D ultrasound features such as echoes and morphology. Higher shear modulus values indicate the upper trapezius tissue is stiffer.
Measured: Baseline, immediately after treatment
Secondary outcomes (3)
Cervical range of motion (ROM)
Cervical spine mobility is assessed as active range of motion (A-ROM), including forward flexion, backward extension, side bending on both sides, and rotation on both sides. The higher the score (angle value), the greater the active movement range of the neck (which is better)
Measured: Baseline, immediately after treatment
Neck Disability Index (NDI-TH)
The NDI-TH consists of 10 items, each worth 5 points, with a total score ranging from 0 (no disability) to 50 (complete paralysis). The higher the score, the more severe the functional impairment.
Measured: Baseline, immediately after treatment
Changes in oxygenated hemoglobin (HbO₂) concentration in the prefrontal and motor-related brain areas measured by multi-channel functional near-infrared spectroscopy (fNIRS)
We used a multi-channel functional near-infrared spectroscopy (fNIRS) device with light source wavelengths set at 730 nm and 850 nm, and a sampling rate of 11 Hz. The device had 24 light sources and 16 detectors, giving a total of 48 measurement channels. The probes were placed according to the international 10-20 EEG system, with an average distance of 30 mm between light sources and detectors. The regions of interest included the left and right prefrontal cortex (PFC), left and right dorsolateral prefrontal cortex (DLPFC), premotor cortex / supplementary motor area (PMC/SMA), primary motor cortex (M1), and primary somatosensory cortex (S1). We preprocessed the raw data from the corresponding channels for each brain region and averaged the channels within each region to get the HbO₂ concentration for that area. Higher oxygenated hemoglobin values indicate higher local blood oxygen levels in that brain region.
Measured: Baseline, immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Juntao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Juntao, The Third People's Hospital of Huizhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892495
- Sponsor's protocol ID
- 2026-KY-149-01
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No