- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07522710
Clinical Study on Intensive Multi-acupuncture in the Treatment of Neck and Shoulder Myofascial Pain Syndrome
Clinical Study on the Treatment of Neck and Shoulder Pain by Intensive Multi-acupuncture Method Based on the Principle of "Tendons Disease Pain-point Needling".
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: yeying yeying
- Phone Number: 15679234887
- Email: yeyinging931@163.com
Study Contact Backup
- Name: jiangyongliang jyl
- Phone Number: 13858173136
- Email: jyl2182@126.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intensive multi-acupuncture method group
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.
|
The needles are inserted into the subject body to treat the disease.
|
|
Experimental: normal needling group
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.
|
The needles are inserted into the subject body to treat the disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical efficacy evaluation criteria
Time Frame: Through study completion, an average of 1 year
|
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%
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain visual analog scale score(VAS)
Time Frame: Through study completion, an average of 1 year
|
The visual analogue scale (VAS) is used for pain assessment.The basic method is to use a traveling scale of about 10 cm in length,with"0" and"10" scores at each end, with 0 indicating no pain and 10 representing the most severe pain that is intolerable.
|
Through study completion, an average of 1 year
|
|
Neck Disability Index (NDI) score
Time Frame: Through study completion, an average of 1 year
|
The Neck Disability Index (NDI) is a commonly used scale for assessing the degree of cervical pain and associated functional impairment, reflecting the improvement in neck function before and after treatment.
It consists of 10 items, each scored from 0 to 5, with a total score ranging from 0 to 50.
|
Through study completion, an average of 1 year
|
|
Cervical Range of Motion (CROM) scale
Time Frame: Through study completion, an average of 1 year
|
CROM refers to a method for measuring cervical range of motion using the arc of motion.
A medical goniometer is used for measurement, and the degrees of motion are recorded in six directions: flexion, extension, left and right lateral flexion, and left and right rotation.
|
Through study completion, an average of 1 year
|
|
Constant-Murley Score (CMS) scale
Time Frame: Through study completion, an average of 1 year
|
The CMS is a multidimensional scale widely used to assess shoulder joint function, covering four aspects: pain, activities of daily living, range of motion, and muscle strength.
The total score is 100, with a higher score indicating better shoulder joint function.
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZSLL-ZN-2026-008-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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