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A randomized controlled study on the analgesic treatment of migraine in acute phase with the combination of horizontal penetration needling and rizatritan

Registration number：

ITMCTR2024000156

Date of Last Refreshed on：

2024-08-01

Date of Registration：

2024-08-01

Registration Status：

Prospective registration

Public title：

A randomized controlled study on the analgesic treatment of migraine in acute phase with the combination of horizontal penetration needling and rizatritan

English Acronym：

Scientific title：

A randomized controlled study on the analgesic treatment of migraine in acute phase with the combination of horizontal penetration needling and rizatritan

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Renzhong Kou

Study leader：

Renzhong Kou

Applicant telephone：

15861813731

Study leader's telephone：

15861813731

Applicant Fax：

Study leader's fax：

Applicant E-mail：

530950775@qq.com

Study leader's E-mail：

530950775@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

157 Daming Road, Nanjing, JiangsuProvince

Study leader's address：

157 Daming Road, Nanjing, Jiangsu Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Nanjing Hospital of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

KY2024046

Approved file of Ethical Committee：

View

Name of the ethic committee：

EEthics Committee of Nanjing Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/7/4 0:00:00

Contact Name of the ethic committee：

Desong Kong

Contact Address of the ethic committee：

157 Daming Road, Nanjing, JiangsuProvince

Contact phone of the ethic committee：

02552276505

Contact email of the ethic committee：

kongds@njucm.edu.cn

Primary sponsor：

Nanjing Hospital of Traditional Chinese Medicine

Primary sponsor's address：

157 Daming Road, Nanjing, JiangsuProvince

Secondary sponsor：

Country：

China

Province：

Jiangsu

City：

Nanjing

Institution
hospital：

Nanjing Hospital of Traditional Chinese Medicine

Address：

157 Daming Road, Nanjing, JiangsuProvince

Source(s) of funding：

Key Laboratory of Needle and Drug Combination of Ministry of Education (Nanjing University of Chines

Target disease：

migraine

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

This study intends to expand the sample size on the basis of previous studies, and conduct a randomized controlled study on the efficacy and safety of "needling flat acupuncture method" combined with rizatriptan in the treatment of migraine pain in the acute phase, so as to verify the advantages of the combination of acupuncture and medicine in terms of efficacy and safety, and clarify its scope of adaptation, so as to provide clinical evidence for further promotion of our team's combination of acupuncture and medicine for the prevention and treatment of migraine.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

①Meet the diagnostic criteria of migraine without aura and migraine with aura; ②Aged 18-50 years, with a history of migraine for more than 12 months; ③In the acute phase, the pain degree was evaluated by visual analogue scale (VAS) method with 4 points or more; ④Patients voluntarily received relevant acute analgesia treatment and signed informed consent.

Exclusion criteria：

①Patients with hypertension and current unstable blood pressure control (stage 2, high-risk patients and above), coronary heart disease (including patients with pacemakers), cerebral infarction and other cardiovascular and cerebrovascular stenosis or obstructive diseases, peripheral vascular stenosis and obstruction; ②Patients with severe primary diseases such as liver, kidney, digestion and blood system; ③Mental patients, or patients with infection and bleeding; ④Pregnant or lactating women; ⑤Patients with organic lesions; ⑥Patients who cannot understand and cooperate with the visual analogue scale (VAS) method.

Study execute time：

From 2024-08-15

To      2025-12-31

Recruiting time：

From 2024-08-15

To      2025-12-31

Interventions：

50

Group：

Acupuncture combined with medicine group

Sample size：

Intervention：

horizontal penetration needling and rizatriptan monobenzoate tablets

Intervention code：

50

Group：

Western medicine group

Sample size：

Intervention：

rizatriptan monobenzoate tablets

Intervention code：

50

Group：

Acupuncture group

Sample size：

Intervention：

horizontal penetration needling

Intervention code：

Total sample size ： 150

Countries of recruitment
and research settings：

Country：

china

Province：

jiangsu

City：

nanjing

Institution/hospital：

Nanjing Hospital of Traditional Chinese Medicine

Level of the institution：

3

Outcomes：

Outcome：

2h Headache remission rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Safety evaluation

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

2h headache disappearance rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

24h headache remission rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

24h headache disappearance rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
50
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The SPSS 22.0 software gives the random numbers

Blinding：

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：

CRF

Data Managemen Committee：

No

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

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