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Clinical study of Qihuang needle therapy in the treatment of mixed cervical spondylosis based on infrared thermal imaging technology

Registration number：

ITMCTR2025000040

Date of Last Refreshed on：

2025-01-07

Date of Registration：

2025-01-07

Registration Status：

Retrospective registration

Public title：

Clinical study of Qihuang needle therapy in the treatment of mixed cervical spondylosis based on infrared thermal imaging technology

English Acronym：

Scientific title：

Clinical study of Qihuang needle therapy in the treatment of mixed cervical spondylosis based on infrared thermal imaging technology

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Huang Bingjing

Study leader：

Huang Bingjing

Applicant telephone：

13055557689

Study leader's telephone：

13055557689

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1634113665@qq.com

Study leader's E-mail：

1634113665@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Unit 703 Building 32 Shing Sheung Yun Garden Hanxiao Avenue Yannan Street Yong'an Sanming Province Fujian province China

Study leader's address：

Unit 703 Building 32 Shing Sheung Yun Garden Hanxiao Avenue Yannan Street Yong'an Sanming Province Fujian province China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Sanming Second Hospital

Approved by ethic committee：

Approved No. of ethic committee：

GZYLL(KY)-2023-027

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Theory Committee of Guangzhou University of Chinese Medicine Shenzhen Hospital (Futian)

Date of approved by ethic committee：

2023/8/1 0:00:00

Contact Name of the ethic committee：

Lu Lin

Contact Address of the ethic committee：

No. 6001 Beihuan Avenue Futian District Shenzhen Guangdong Province China

Contact phone of the ethic committee：

0755-83548506

Contact email of the ethic committee：

gzyszyyll@126.com

Primary sponsor：

Guangzhou University of Chinese Medicine Shenzhen Hospital (Futian))

Primary sponsor's address：

No. 6001 Beihuan Avenue Futian District Shenzhen Guangdong Province China

Secondary sponsor：

Country：

China

Province：

Guangdong Province

City：

Shenzhen

Institution
hospital：

Guangzhou University of Chinese Medicine Shenzhen Hospital (Futian))

Address：

No. 6001 Beihuan Avenue Futian District Shenzhen Guangdong Province China

Source(s) of funding：

Graduate graduation project

Target disease：

mixed cervical spondylosis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

Implement a randomized controlled clinical study to compare the efficacy difference of Qihuang needle therapy and ordinary acupuncture therapy for mixed cervical spondylosis (mainly cervical type cervical spondylopathy and mixed cervical spondylotic radiculopathy). The main indicators are Visual Analog Scale/Score (VAS) Neck Disability Index (NDI) and Tanaka Yasuhisa Cervical Disease Symptom Scale. The secondary indicators are the average temperature value (∆ t) measured by Infrared Thermal Imaging (ITI) and the Root Mean Square (RMS) measured by Surface Electromyography (sEMG). And using SPSS software to analyze the correlation between ∆ t and RMS in the experimentAnd analyze the correlation between the average body surface temperature (∆t) of infrared thermal imaging (ITI) in the experiment and the root mean square (RMS) value measured by surface electromyography (sEMG) in order to provide certain evidence support for infrared thermal imaging technology as a clinical efficacy indicator for evaluating the treatment of mixed cervical spondylosis with Qihuang needle and further enrich the theoretical basis of Qihuang needle therapy for mixed cervical spondylosis in clinical practice.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Meet the diagnostic criteria for mixed cervical spondylosis (CCS mixed CSR) in the Expert Consensus on Classification Diagnosis and Non-surgical Treatment of Cervical Spondylosis and the Diagnostic Efficacy Criteria for Orthopedic Syndromes of Traditional Chinese Medicine; ② Be between the ages of 20-65;③ Patients who have signed the informed consent form and can cooperate to complete the treatment.

Exclusion criteria：

① Other subtypes of cervical spondylosis; ② Traumatic cervical spondylosis cervical fractures and dislocations; ③ Rheumatism rheumatoid arthritis tumors tuberculosis severe osteoporosis congenital malformations and other diseases; ④ Individuals with bleeding tendencies and coagulation disorders; ⑤ Patients with serious cardiovascular and cerebrovascular diseases diabetes high fever local skin damage and severe skin peptide disease; ⑥ Patients with acute infectious diseases systemic infection or infectious disease at the treatment site: patients with damaged neck skin and severe skin disease; ⑦ Pregnant or lactating women and mentally ill patients who are unable to live; ⑧ Those who have not been treated according to regulations and cannot determine the efficacy.

Study execute time：

From 2023-09-01

To      2024-03-01

Recruiting time：

From 2023-09-01

To      2024-03-01

Interventions：

35

Group：

2

Sample size：

Intervention：

ordinary acupuncture therapy

Intervention code：

35

Group：

1

Sample size：

Intervention：

Qihuang needl

Intervention code：

Total sample size ： 70

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong province

City：

Shenzhen

Institution/hospital：

Guangzhou University of Chinese Medicine Shenzhen Hospital (Fukuda)

Level of the institution：

Third Grade First Class Hospital

Outcomes：

Outcome：

20 point Tianzhong Jingjiu Cervical Symptom Scale data

Type：

Primary indicator

Measure time point of outcome：

0 days; 14 days; 28 days

Measure method：

scale

Outcome：

Visual Analogue Scale/Score; VAS

Type：

Primary indicator

Measure time point of outcome：

0 days; 14 days; 28 days

Measure method：

scale

Outcome：

Neck Disability Index; NDI

Type：

Primary indicator

Measure time point of outcome：

0 days; 14 days; 28 days

Measure method：

scale

Outcome：

the root mean square (RMS) of upper trapezius

Type：

Secondary indicator

Measure time point of outcome：

0 days; 14 days

Measure method：

surface Electromyography; sEMG

Outcome：

average body surface temperature of upper trapezius

Type：

Secondary indicator

Measure time point of outcome：

0 days; 14 days

Measure method：

infrared thermal imaging

Collecting sample(s)
from participants：

Completed

20
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

This study used a simple randomization method and the project leader divided 70 patients equally into two groups according to a 1:1 control principle. Use SPSS27.0 statistical software to generate random numbers create random allocation cards and put them into opaque envelopes with numbers. The number on the envelope must be the same as the number on the card. According to the order of inclusion in the study compare the envelope numbers and open them strictly follow the card numbers for grouping and treatment.

Blinding：

IPD sharing：

Yes

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

The 2024 uploaded the raw data to the International Tradition（http://http://itmctr.ccebtcm.org.cn/）al Medicine Clinical Registry on Dec. 6

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

The data collection for this study was carried out by the project leader using a paper version of the Case Record Form (CRF) who asked each enrolled research subject to fill out the form one by one collected and saved the paper version of the report results and compiled them into a book. This study has not yet implemented an electronic collection management system.

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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