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Observation on the clinical effect of acupuncture regulating muscle softening tendons and bone-setting in the treatment of cervical spondylosis

Registration number：

ITMCTR2024000268

Date of Last Refreshed on：

2024-08-20

Date of Registration：

2024-08-20

Registration Status：

Retrospective registration

Public title：

Observation on the clinical effect of acupuncture regulating muscle softening tendons and bone-setting in the treatment of cervical spondylosis

English Acronym：

Scientific title：

Observation on the clinical effect of acupuncture regulating muscle softening tendons and bone-setting in the treatment of cervical spondylosis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Youjia Gu

Study leader：

Wenguang Hou

Applicant telephone：

13775013143

Study leader's telephone：

13564567336

Applicant Fax：

Study leader's fax：

Applicant E-mail：

740218480@qq.com

Study leader's E-mail：

houwenguang@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

The second Department of Acupuncture and Moxibustion, No. 110 Ganhe Road, Hongkou District, Shanghai

Study leader's address：

The second Department of Acupuncture and Moxibustion, No. 110 Ganhe Road, Hongkou District, Shanghai

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Yueyang Hospital of Integrated Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024-068

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Yueyang Hospital of Integrated Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/4/11 0:00:00

Contact Name of the ethic committee：

Congquan Yin

Contact Address of the ethic committee：

The second Department of Acupuncture and Moxibustion, No. 110 Ganhe Road, Hongkou District, Shanghai

Contact phone of the ethic committee：

+86 21 6516 1782

Contact email of the ethic committee：

yyyyllwyh@163.com

Primary sponsor：

Yueyang Hospital of Integrated Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

Primary sponsor's address：

The second Department of Acupuncture and Moxibustion, No. 110 Ganhe Road, Hongkou District, Shanghai

Secondary sponsor：

Country：

China

Province：

Shanghai

City：

Institution
hospital：

Yueyang Hospital of Integrated Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

Address：

The second Department of Acupuncture and Moxibustion, No. 110 Ganhe Road, Hongkou District, Shanghai

Source(s) of funding：

Yueyang Hospital of Integrated Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

Target disease：

Cervical spondylopathy

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

In recent years, relevant studies have confirmed that the occurrence and development of cervical spondylosis is closely related to the lesions of the muscular system around the cervical spine, and it is believed that cervical spondylosis is a syndrome caused by the injury and spasticity of the cervical vertebrae-related muscles leading to changes in the relative position of adjacent muscles and bones. The neck muscles play an important role in the development and treatment of cervical spondylosis. In response to this problem, our team also carried out preliminary clinical observation. Instead of selecting conventional points such as bilateral neck and spine, we directly started from the muscles causing muscle tension, cervical lateral curvature and physiological curvature of cervical spine of patients, and selected corresponding acupuncture points for acupuncture treatment on the basis of targeted differentiation of the muscles on the affected side. The relaxation and adjustment of muscles drove the adjustment of bones, so as to achieve the purpose of regulating muscle bone and softening tendons. Relieve cervical spondylosis caused by neck pain, muscle tension and other symptoms, correct posture, the effect is significant. In order to further verify the idea and method of acupuncture regulating muscle bone and softening tendons, the experiment is looking for the optimal treatment of cervical spondylosis.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Meet the western medical diagnostic criteria for cervical spondylosis; (2) Age ≥18 years old and ≤59 years old, gender is not limited; (3) No language barrier, can understand the content of the scale; (4) those who have not received any other form of treatment within the last 1 month; (5) The subject is willing, can actively cooperate, and signs the informed consent.

Exclusion criteria：

(1) Patients with other neck diseases, such as neck trauma, fracture, dislocation or surgical history, congenital spinal abnormalities, cervical bone and joint tuberculosis, tumors, and space-occupying lesions in the spinal canal; (2) suffering from other serious diseases of the viscera system (heart, liver, lung, kidney, brain, etc.) or mental disorders; (3) suffering from diseases related to coagulation dysfunction; (4) Patients with a history of neck trauma or surgery, or serious skin lesions or infections at the treatment site; (5) People who are allergic or allergic to acupuncture needles, dizzy or afraid of pain; (6) Pregnant and lactating women.

Study execute time：

From 2024-04-15

To      2025-04-15

Recruiting time：

From 2024-04-15

To      2025-04-15

Interventions：

36

Group：

Experimental group

Sample size：

Intervention：

Health education guidance + acupuncture regulating muscle soft tendons and bone-setting method

Intervention code：

36

Group：

Control group

Sample size：

Intervention：

Health education guidance +Pseudoacupuncture group

Intervention code：

Total sample size ： 72

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Institution/hospital：

Yueyang Hospital of Integrated Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Neck Disability Index , NDI

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Evaluation of shoulder and neck morphology

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Body surface infrared thermal imaging

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Physiological curvature of the cervical spine

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Cervical motion

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Mc Gill pain questionnaire,MPQ

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

none

Tissue：

Fate of sample 

Others

Note：

Recruiting

18
Min age years
59
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

The SPSS25.0 random number generator was used to generate 72 random numbers between 0 and 1, corresponding serial numbers 1-72, and the random numbers were divided into two groups by visual boxed classification, then their corresponding serial numbers were automatically divided into two groups.

Blinding：

This study adopts single blindness, and the blind subjects are the subjects. The subjects in the experimental group received conventional treatment + muscle softening and bone setting method, and the subjects in the control group received conventional treatment + false acupuncture method.

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

-

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

-

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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