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Clinical Efficacy Evaluation and Mechanism Study of Acupuncture Treatment for Cervical Dystonia

Registration number：

ITMCTR2024000503

Date of Last Refreshed on：

2024-09-29

Date of Registration：

2024-09-29

Registration Status：

Retrospective registration

Public title：

Clinical Efficacy Evaluation and Mechanism Study of Acupuncture Treatment for Cervical Dystonia

English Acronym：

Scientific title：

Clinical Efficacy Evaluation and Mechanism Study of Acupuncture Treatment for Cervical Dystonia

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Zhang Jinjing

Study leader：

Zhang Jinjing

Applicant telephone：

15922410659

Study leader's telephone：

15922410659

Applicant Fax：

Study leader's fax：

Applicant E-mail：

15922410659@139.com

Study leader's E-mail：

15922410659@139.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 117 Meishan Road Shushan District Hefei Anhui Province

Study leader's address：

No. 117 Meishan Road Shushan District Hefei Anhui Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The First Affiliated Hospital of Anhui University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2023AH-63

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical ethics committee of The first affiliated hospital of Anhui university of Chinese Medicine(Anhui Provincial Hospital of Chinese Medicine)

Date of approved by ethic committee：

2023/11/13 0:00:00

Contact Name of the ethic committee：

Xu Guiqin

Contact Address of the ethic committee：

Scientific Research Department The First Affiliated Hospital of Anhui University of Chinese Medicine No.117 Meishan Road Shushan District Hefei Anhui Province

Contact phone of the ethic committee：

0551 6283 8532

Contact email of the ethic committee：

xuqin608@163.com

Primary sponsor：

The First Affiliated Hospital of Anhui University of Chinese Medicine

Primary sponsor's address：

No. 117 Meishan Road Shushan District Hefei Anhui Province

Secondary sponsor：

Country：

China

Province：

Anhui

City：

Hefei

Institution
hospital：

The First Affiliated Hospital of Anhui University of Chinese Medicine

Address：

No. 117 Meishan Road Shushan District Hefei Anhui Province

Source(s) of funding：

Science and Technology Department of Anhui Province

Target disease：

Cervical Dystonia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

1. Based on the clinical experience of famous Chinese medicine special acupuncture and moxibustion methods were adopted to treat spastic torticollis and modern science and technology were used to objectively evaluate the clinical effectiveness and safety of acupuncture and moxibustion for spastic torticollis; 2. Through functional magnetic resonance imaging block design activation images of brain areas were collected to partially reveal the mechanism of acupuncture in the treatment of spastic torticollis.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Meeting the diagnostic criteria of spastic torticollis; ②Age 16-65 years old gender is not limited; ③ The course of disease is less than or equal to 1 year; ④ If the oral antispasticity drug is not effective at least 3 months from the last oral drug treatment; ⑤All patients had not received local injection of botulinum toxin type A before or more than 3 months after the last botulinum toxin treatment could be enrolled in the study; ⑥ Voluntarily sign the informed consent of the trial and can cooperate with and adhere to acupuncture treatment. Note: Only those with the above 6 items can be included in this study.

Exclusion criteria：

① If the head MRI or CT cervical CT or plain film examination found that there are organic diseases of the skull and neck; ② Secondary spasmodic torticollis and other dystonic diseases caused by drugs injuries tumors etc.; ③ Patients with severe spastic torticollis were excluded; ④ The interval between the last injection of Botox is less than 3 months or it is still effective. ⑤Patients who had received selective radiculotomy cervical muscle amputation and pallidectomy were not included in this study; Have serious heart liver lung kidney and other internal diseases. Note: Patients meeting any of the above criteria were excluded.

Study execute time：

From 2023-09-14

To      2026-09-13

Recruiting time：

From 2023-11-14

To      2026-09-13

Interventions：

30

Group：

Western medicine section

Sample size：

Intervention：

Inject freeze-dried crystal botulinum toxin type A

Intervention code：

30

Group：

Acupuncture and moxibustion group

Sample size：

Intervention：

electric acupuncture

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Anhui

City：

Hefei

Institution/hospital：

The First Affiliated Hospital of Anhui University of Chinese Medicine

Level of the institution：

Class III Class A general hospital

Country：

China

Province：

China

City：

Hefei

Institution/hospital：

Anhui Provincial Hospital of Integrated Traditional Chinese and Western Medicine - Institute of Neurology

Level of the institution：

Class II Class A hospital

Country：

China

Province：

anhui

City：

qianshan

Institution/hospital：

Qianshan Hospital of TCM

Level of the institution：

Third level Traditional Chinese Medicine Hospital

Outcomes：

Outcome：

Tsui scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Ultrasonics

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

fMRI

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Pittsburgh Sleep Quality Index Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Surface electromyography

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

West Toronto spastic Torticollis Scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hospital Anxiety and Depression Scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

without

Tissue：

Fate of sample 

Others

Note：

Recruiting

16
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)：

In this study a single blind method was adopted for efficacy evaluators and the scale evaluation was completed by a third party to minimize bias caused by subjective factors of researchers.

Blinding：

IPD sharing：

No

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

without

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

Data collection: (1) Scale score: ①Tsui scale; ② West Toronto Spastic Torticollis Scale (TWSTRS); ③ Hospital Anxiety and Depression Scale (HADS); Pittsburgh Sleep Quality Index Scale (PSQI); (2) Ultrasound related indexes: ① Thickness of bilateral sternocleidomastoid muscle and Young model value; ②Thickness and Young's modulus of muscle of both sides of head clamp; (3) Surface electromyography: ① Power frequency values (MPF) of both sternocleidomastoid muscles and trapezius muscles; ② Average electromyography values (AEMG) of bilateral sternocleidomastoid muscle and trapius muscle (4) fMRI: Data were analyzed using relevant software after whole brain scan of CD patients in the acupuncture group. Clinical scales (Tsui TWSTRS HADS PSQI) were collected before the first treatment at 4 and 8 weeks after treatment and at 12 and 20 weeks of follow-up. The relevant indexes of ultrasound and surface EMG were collected before treatment and at the 4th and 8th week after treatment. In the acupuncture group fMRI was collected before the first treatment and within 2 days after the last treatment.

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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