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Clinical RCT study of moxibustion for knee osteoarthritis based on the theory of

Registration number：

ITMCTR2100005303

Date of Last Refreshed on：

2021-09-12

Date of Registration：

2021-09-12

Registration Status：

Prospective registration

Public title：

Clinical RCT study of moxibustion for knee osteoarthritis based on the theory of

English Acronym：

Scientific title：

Acupuncture

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100051088 ; ChiMCTR2100005303

Applicant：

WANGPei

Study leader：

WANGPei

Applicant telephone：

18851821529

Study leader's telephone：

18851821529

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1477562073@qq.com

Study leader's E-mail：

1477562073@qq.com

Study leader's website(voluntary supply)：

江苏省太湖疗养院

Study leader's website
(voluntary supply)：

Applicant address：

Jiangsu Provincial Cadre's Sanatorium ，Wuxi Jiangsu

Study leader's address：

Jiangsu Provincial Cadre's SanatorJiangsu Provinium ，Wuxi Jiangsu

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Jiangsu Provincial Cadre's Sanatorium

Approved by ethic committee：

Approved No. of ethic committee：

20201001

Approved file of Ethical Committee：

View

Name of the ethic committee：

Jiangsu Provincial Cadre's Sanatorium

Date of approved by ethic committee：

1990/1/1 0:00:00

Contact Name of the ethic committee：

YUAN Fangcen

Contact Address of the ethic committee：

Jiangsu Provincial Cadre's SanatorJiangsu Provinium ，Wuxi Jiangsu

Contact phone of the ethic committee：

18851821529

Contact email of the ethic committee：

1477562073@qq.com

Primary sponsor：

Jiangsu Provincial Cadre's Sanatorium

Primary sponsor's address：

Jiangsu Provincial Cadre's SanatorJiangsu Provinium ，Wuxi Jiangsu

Secondary sponsor：

Country：

CHINA

Province：

Jiangsu

City：

Institution
hospital：

Jiangsu Provincial Cadre's Sanatorium

Address：

Jiangsu Provincial Cadre's SanatorJiangsu Provinium ，Wuxi Jiangsu

Source(s) of funding：

General project research funding of Jiangsu Provincial Health Commission

Target disease：

Knee Osteoarthritis

Target disease code：

Study type：

Treatment study

Study design：

Case-Control study

Study phase：

Others

Objectives of Study：

Analyze the difference in clinical efficacy of two different moxibustion programs, and then scientifically evaluate the effectiveness, safety and feasibility of their treatment programs, in order to further optimize the KOA treatment program and provide references for clinical treatment.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Meet the diagnostic criteria for knee osteoarthritis of the American Academy of Rheumatology; (2) In most days of the past month, knee joint pain was at least moderate or below (pain numerical score method, namely VAS score<7); (3) Age 40-75 years old (including 40 and 75 years old); (4) Subjects stop analgesics and only allow them to take related drugs when the pain is unbearable, such as analgesics or non-steroidal anti-inflammatory drugs. But subjects cannot take hormone drugs; (5) Willing to sign an informed consent form. Note: Patients who meet the above 5 items at the same time can be included in this study.

Exclusion criteria：

(1) Those who have received hormone therapy in the past 3 months; (2) Receive intra-articular hyaluronidase injections within the past 6 months; (3) Received joint irrigation or arthroscopy in the past year; (4) Diseases that hinder the safe participation of experimental design and the completion of the research, such as severe systemic diseases such as myocardial infarction or stroke, congestive heart failure, severe chronic obstructive pulmonary disease, cancer, diabetes, etc. in the past 3 months. Severe mental illness; (5) Physical history or clinical manifestations with bleeding tendency, including the current use of anticoagulants; (6) Inflammatory arthritis (such as rheumatoid or psoriasis), this trial will test subjects for rheumatoid factor, erythrocyte sedimentation rate, and anti-O to exclude the possibility of rheumatoid arthritis (7) Participate in other research at the same time; (8) Those who have had knee replacement surgery; (9) Participated in the related treatment of knee osteoarthritis trial in the past; (10) Those who are excessively fearful of needle knives; (11) At the same time local use of external treatment methods, such as local application treatment, etc.; (12) Unable to complete various scales; (13) Unwilling to be randomly grouped. Note: Patients who meet any of the above items will be excluded.

Study execute time：

From 2021-10-01

To      2022-10-31

Recruiting time：

From 2021-10-01

To      2022-10-31

Interventions：

44

Group：

Control group

Sample size：

Intervention：

Moxibustion

Intervention code：

44

Group：

therapy group

Sample size：

Intervention：

Moxibustion

Intervention code：

Total sample size ： 88

Countries of recruitment
and research settings：

Country：

CHINA

Province：

Jiangsu

City：

--请选择--

Institution/hospital：

Jiangsu Provincial Cadre's Sanatorium

Level of the institution：

provincial

Outcomes：

Outcome：

IL-1、IL-17、TNF-α、OPG、PCTBGP、

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

serum

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

40
Min age years
75
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 method adopts central randomization. After subjects meet the selection criteria and sign an informed consent form, the researchers of each clinical sub-center will apply for a random number to the central data administrator through telephone, text message, WeChat, etc. The central data administrator w

Blinding：

IPD sharing：

Yes

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

ResMan（www.medresman.org）

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

Case report 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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