NCT07522710

Brief Summary

In this study, the proposed subjects came from the Traditional Diagnosisand Treatment Center of Zhongshan Hospital of Zhejiang Province.78 patients with neck and shoulder pain who met the criteria were randomly divided into the control group (39 cases) and the experimental group (39 cases) in a ratio of 1:1.The control group used ordinary acupuncture methods,and the experimental group adopted intensive mtlti-acupuncture method for intervention.The treatment was carried out twice a week,with 4 times as a course of treatment,for a total of one couse of treatment. The data of VAS NDI,Cervical Range of Motion Assessment,and Constant-Murley Score of the two grous were recorded at the baseline period,after the 2nd treatment,after the 4th treatment,and 2 weeks after the end of the treatment for follow-up.All data were statistically analyzed using SPSS27.0 software,and relevant differences were compared after treatment. In order to evaluate the effectiveness of intensive multi-acupuncture method in the treatment of neck and shoulder pain,and to promote the development and clinical application of"pain as adupoint" meridian stabbing method.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

March 20, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 22, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2027

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

March 20, 2026

Last Update Submit

April 3, 2026

Conditions

Keywords

Neck and Shoulder Myofascial Pain SyndromeNeck Pain

Outcome Measures

Primary Outcomes (1)

  • clinical efficacy evaluation criteria

    It was evaluated according to the efficacy standard of neck and shoulder pain in the Guidelines for Clinical Research of New Chinese Medicines, and the NDI index was used as the benchmark: Efficacy index (N) = \[(pre-treatment score - post-treatment score) ÷ pre-treatment score\] × 100% * cure: the patient does not feel obvious back pain and other discomforts, N ≥ 90% * Effective: Effective: low back pain is significantly relieved, 60% ≤ N \< 90% ③ Effective: lower back pain is relieved, 30%≤N\<60%. ④ Ineffective: the patient's low back pain is not relieved, N\<30%. Total effective rate (%) = \[(number of cured + number of effective + number of effective) ÷ number of cases in each group\] × 100%.

    Through study completion, an average of 1 year

Secondary Outcomes (4)

  • Pain visual analog scale score(VAS)

    Through study completion, an average of 1 year

  • Neck Disability Index (NDI) score

    Through study completion, an average of 1 year

  • Cervical Range of Motion (CROM) scale

    Through study completion, an average of 1 year

  • Constant-Murley Score (CMS) scale

    Through study completion, an average of 1 year

Study Arms (2)

intensive multi-acupuncture method group

EXPERIMENTAL

Perpendicular or oblique insertion in the occipital region reaching the periosteal attachment of the superior/inferior nuchal lines; after the needle tip contacts the bone surface, perform mild lifting and thrusting to elicit a sour and distending sensation, with a depth ≤ 3 cm. In the posterior neck, insert along the paravertebral region adjacent to the spinous processes from C2 to T2 and the articular processes using a subperiosteal technique, advancing along the spinous processes with the depth controlled within 0.5 cm beneath the bone surface. In the infraspinous fossa of the scapula, insert perpendicularly toward the bone surface; along the scapular medial border, insert obliquely parallel to the ribs. In the anterior shoulder region, insert at the coracoid process area and the intertubercular groove of the humerus at a 45° oblique angle until the needle tip contacts the bone surface.The treatment is performed twice a week for a total of 4 treatments.

Procedure: Acupuncture

normal needling group

EXPERIMENTAL

The points were selected with reference to the 2006 National Standard of the People's Republic of China(GB/T 12346-2006),"Acupoint Names and Localization".The patients were placed in the prone position, the acupoints were sterilized with 75% alcohol, and the needles were inserted vertically with the conventional needling method, to the extent that there was a sensation of acidity,numbness,heaviness, distension,or radiating to the surroundings, and the needles were left in place for 15 min. The treatments were carried out twice a week for a total of four treatments.

Procedure: Acupuncture

Interventions

AcupuncturePROCEDURE

The needles are inserted into the subject body to treat the disease.

intensive multi-acupuncture method group

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the above diagnostic criteria for both Chinese and Western medicine;
  • Aged between 18 and 69 years, with no gender restriction; ③ Disease duration of more than 3 months, with no other treatment received within the past month; ④ Voluntarily participate in this study, comply with the physician's arrangements, cooperate with treatment, and sign the Informed Consent Form.

You may not qualify if:

  • Patients with severe life-threatening primary diseases such as severe cardiac, hepatic, renal, or hematopoietic system disorders, as well as those with psychiatric conditions;
  • Patients with pre-existing diseases that may affect the diagnosis of this condition, such as spinal cord injury, significant cervical disc herniation or spondylolisthesis, cervical compression fracture, whiplash injury, etc., as well as those complicated by visceral disorders presenting with similar symptoms; ③ Women who are pregnant or breastfeeding, for whom acupuncture treatment is not suitable;
  • Patients with a history of needle phobia, hemophobia, bleeding tendency, or coagulation disorders;
  • Patients with ulcers or suspected infection on the local body surface; ⑥ Patients who have received other treatments within the past two weeks that may potentially affect the observation of the study outcomes; ⑦ Patients with cognitive impairments who are unable to independently complete the relevant scale assessments or do so under the guidance of the researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

jiangyongliang jyl

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

March 20, 2026

First Posted

April 13, 2026

Study Start

March 22, 2026

Primary Completion (Estimated)

March 3, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04