The Clinical Efficacy and Multimodal Imaging Mechanism of the Knot-tying Technique in the Treatment of Chronic Neck Pain

NCT07892495 | Not Yet Recruiting

• 1 other identifier: 2026-KY-149-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 1.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.
2. 2.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

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Baseline, immediately after treatment

Secondary Outcomes (3)

• Cervical range of motion (ROM)

  Baseline, immediately after treatment

• Neck Disability Index (NDI-TH)

  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)

  Baseline, immediately after treatment

Study Arms (2)

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

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.

Other: Sham acupuncture

Interventions

Untangling Needle Therapy: Acupuncture with Untangling Needle OTHER

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.

Experimental group: JieJie Needle Therapy: needling with JieJie needles

Sham acupuncture OTHER

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.

Control group: sham acupuncture

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Li Juntao: lead

Central Study Contacts

Juntao Li

CONTACT

+86 15976183336; derk82@163.com

Gurong Cun

CONTACT

+86 15925445007; 2825199454@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Director of the Neurological Rehabilitation Ward at the Rehabilitation Medicine Center

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share