An interventional study of Untangling Needle Therapy: Acupuncture with Untangling Needle and Sham acupuncture in Chronic Neck Pain, sponsored by Li Juntao. Not yet recruiting. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Li Juntao · Not applicable, Interventional, and Treatment
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:
1,360 studies on the registry are indexed under Neck Pain; 299 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 1,116 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →This is the only study on the registry with Li Juntao as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meet the diagnostic criteria for chronic neck pain;
Aged 20-65, any gender;
Exclusion Criteria:
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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Untangling Needle Therapy: Acupuncture with Untangling Needle
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.
Other: Sham acupuncture
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 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.
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)
Time frame: 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.
Time frame: Baseline, immediately after treatment
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)
Time frame: 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.
Time frame: 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.
Time frame: Baseline, immediately after treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2028, 23 months later.
Of 763 non-industry interventional studies with no phase under Neck Pain, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 23 months is above that.
Counting every sponsor, half of 772 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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