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A metabolomic study of acupuncture force-mining acupoints for the treatment of lumbar disc herniation

Registration number：

ITMCTR2024000816

Date of Last Refreshed on：

2024-12-13

Date of Registration：

2024-12-13

Registration Status：

Prospective registration

Public title：

A metabolomic study of acupuncture force-mining acupoints for the treatment of lumbar disc herniation

English Acronym：

Scientific title：

A metabolomic study of acupuncture force-mining acupoints for the treatment of lumbar disc herniation

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Mengyingqing

Study leader：

Zhanghaifeng

Applicant telephone：

15211539165

Study leader's telephone：

13576920759

Applicant Fax：

Study leader's fax：

Applicant E-mail：

3335412564@qq.com

Study leader's E-mail：

3335412564@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 445 Bayi Avenue Donghu District Nanchang Jiangxi Province China

Study leader's address：

No. 445 Bayi Avenue Donghu District Nanchang Jiangxi Province China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

the Affiliated Hospital of Jiangxi University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

JZFYLL2024006200089

Approved file of Ethical Committee：

View

Name of the ethic committee：

the Medical Ethics Committee of the Affiliated Hospital of Jiangxi University of Chinese Medicine

Date of approved by ethic committee：

2024/6/20 0:00:00

Contact Name of the ethic committee：

Xiongmingyi

Contact Address of the ethic committee：

No. 445 Bayi Avenue Donghu District Nanchang Jiangxi Province China

Contact phone of the ethic committee：

0791-86363831

Contact email of the ethic committee：

853546250@qq.com

Primary sponsor：

the Affiliated Hospital of Jiangxi University of Chinese Medicine

Primary sponsor's address：

No. 445 Bayi Avenue Donghu District Nanchang Jiangxi Province China

Secondary sponsor：

Country：

China

Province：

Jiangxi

City：

Nanchang

Institution
hospital：

the Affiliated Hospital of Jiangxi University of Chinese Medicine

Address：

No. 445 Bayi Avenue Donghu District Nanchang Jiangxi Province China

Source(s) of funding：

Jiangxi Provincial Traditional Chinese Medicine Advantageous Diseases Low Back Pain

Target disease：

lumbar disc herniation

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

The aim of this single-center randomized controlled trial is to evaluate whether there is a significant difference in the efficacy of acupuncture at acupoints with different degrees of sensitisation for the treatment of LDH and to elucidate the mechanism of action at the metabolic level of acupuncture at sensitive acupoints for LDH.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Accordance with the diagnostic criteria for LDH. The diagnostic criteria follows the Guidelines for the Diagnosis and Treatment of Lumbar Intervertebral Disc Herniation published by the Spine Surgery Group of the Orthopaedic Branch of the Chinese Medical Association and the Orthopaedic Rehabilitation Group of the Orthopaedic Branch of the Chinese Medical Association in 2020. ①Low back pain and activity limitation. ②Abnormal sensation of lower limbs. ③Positive nerve pull test mainly including straight leg raising test straight leg raising strengthening test femoral nerve entrapment test contralateral straight leg raising test or positive femoral nerve pull test. ④Weak tendon reflection compared with the unaffected side. ⑤Decrease muscle strength. ⑥MRI or CT scan of the lumbar spine shows a herniated disc and the compressed nerve is consistent with the nerve affected by the symptoms and signs. LDH can be diagnosed when 3 of the first 5 criteria are met in combination with sixth point. (2) 18≤age≤70 years ma

Exclusion criteria：

Patients with any of the following conditions will be excluded: (1) Patients with LDH who have a history of lumbar spine surgery or who have an indication for surgery (symptoms not relieved or even worsened by previous systematic conservative treatment for more than 6 to 12 weeks or symptoms of muscle paralysis and bowel dysfunction caused by cauda equina palsy). (2) Combination of lumbar tuberculosis tumour spinal stenosis and other diseases causing low back pain. (3) Combination of serious heart liver kidney dysfunction or blood disease autoimmune system infectious disease mental disease etc. (4) Pregnant or breastfeeding women. (5) Skin cracks and intolerance to acupuncture treatment in the area of waist and lower limbs.

Study execute time：

From 2024-12-19

To      2025-03-30

Recruiting time：

From 2024-12-20

To      2025-03-30

Interventions：

20

Group：

the higher sensitization group

Sample size：

Intervention：

acupuncture

Intervention code：

20

Group：

the waiting-list group

Sample size：

Intervention：

no

Intervention code：

20

Group：

the lower sensitization group

Sample size：

Intervention：

acupuncture

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangxi

City：

Nanchang

Institution/hospital：

the Affiliated Hospital of Jiangxi University of Chinese Medicine

Level of the institution：

grade 3A

Outcomes：

Outcome：

Serum metabolomics

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Japanese Orthopaedic Association Scores

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Visual Analogue Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
70
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The randomization sequence was generated by Yingqing Meng using excel software and the random allocation card was made according to the results. Subjects included in this study were assigned to the high sensitivity group and the low sensitivity group and the waiting for treatment group in the ratio of 1:1:1. The randomized sequence with impervious that had been filled in with the serial number the random number and the corresponding grouping): the sequence of the visit to the clinic was taken out of the bag with the random allocation card corresponding to the serial number and grouped according to the information on it.

Blinding：

IPD sharing：

Yes

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

lf necessary, please contact the project leader by email

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

Data collection management is carried out by paper CRF form

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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