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Clinical study of different forms of Yijin Jing in the treatment of knee osteoarthritis

Registration number：

ITMCTR2024000234

Date of Last Refreshed on：

2024-08-14

Date of Registration：

2024-08-14

Registration Status：

Prospective registration

Public title：

Clinical study of different forms of Yijin Jing in the treatment of knee osteoarthritis

English Acronym：

Scientific title：

Clinical study of different forms of Yijin Jing in the treatment of knee osteoarthritis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Hu Zehao

Study leader：

Chen Guohua

Applicant telephone：

+86 138 0700 4791

Study leader's telephone：

+86 139 2367 8988

Applicant Fax：

Study leader's fax：

Applicant E-mail：

2384516405@qq.com

Study leader's E-mail：

chenguohua0811@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

3 Shaoshan Road, Longhu District, Shantou City, Guangdong Province

Study leader's address：

3 Shaoshan Road, Longhu District, Shantou City, Guangdong Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

3 Shaoshan Road, Longhu District, Shantou City, Guangdong Province

Approved by ethic committee：

Approved No. of ethic committee：

20230406

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Shantou Hospital of Traditional Chinese Medicine affiliated to Guangzhou University of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/5/11 0:00:00

Contact Name of the ethic committee：

Xie Rushan

Contact Address of the ethic committee：

3 Shaoshan Road, Longhu District, Shantou City, Guangdong Province

Contact phone of the ethic committee：

+86 183 1664 7794

Contact email of the ethic committee：

stszypx@163.com

Primary sponsor：

Shantou Hospital of Traditional Chinese Medicine, Guangzhou University of Traditional Chinese Medicine

Primary sponsor's address：

3 Shaoshan Road, Longhu District, Shantou City, Guangdong Province

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Shantou

Institution
hospital：

Shantou Hospital of Traditional Chinese Medicine, Guangzhou University of Traditional Chinese Medicine

Address：

3 Shaoshan Road, Longhu District, Shantou City, Guangdong Province

Source(s) of funding：

The seventh batch of National Traditional Chinese Medicine experts Academic Experience inheritance Project (National Traditional Chinese Medicine Education Letter (2022) No. 76)

Target disease：

Knee Osteoarthritis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

This study innovatively combined the traditional Yi Jin Jing with Ba Duan Jin and Wu Bird Opera to create an optimised Yi Jin Jing exercise programme in three different forms (seated, horizontal and vertical) for patients with knee osteoarthritis (KOA) of varying degrees of severity; the study was designed to explore the therapeutic efficacy of the modified Yi Jin Jing in the treatment of KOA, and at the same time compare the therapeutic efficacy of conventional medications on the improvement of limb motor function and symptoms in patients with KOA.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Compliance with the diagnostic criteria of osteoarthritis of the knee in Chinese and Western medicine; (2) Meet the imaging diagnosis of stage I, II and III; (3) No obvious cardiac, hepatic, pulmonary or renal insufficiency; (4) Age between 40-75 years old; (5) If they have already received other manipulative or conservative treatments, after a washout period of more than 5 days. (6) Have not participated in systematic or interval training for another sport in the past 6 months (no more than twice a week); (7) No other disabling medical condition (e.g., stroke, Parkinson's disease, etc); (8) Patients who agreed to sign a written informed consent.

Exclusion criteria：

(1) Failure to meet the inclusion criteria; (2) Knee joints with obvious internal and external deformity, consistent with imaging diagnosis of stage IV; (3) Combined with serious primary diseases such as cardiovascular, cerebrovascular, hepatic, renal and haematopoietic systems, serious systemic infections, psychiatric patients, allergic patients, pregnant and lactating women, combined with bone tumours and bone tuberculosis; (4) Those who cannot adhere to the treatment and have incomplete information.

Study execute time：

From 2024-05-11

To      2027-05-11

Recruiting time：

From 2025-01-01

To      2026-12-31

Interventions：

30

Group：

Control group

Sample size：

Intervention：

regular medication treatment

Intervention code：

30

Group：

Modified Yijin Jing exercise group

Sample size：

Intervention：

Modified Yijin Jing exercise+regular medication treatment

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Shantou

Institution/hospital：

Shantou Hospital of Traditional Chinese Medicine, Guangzhou University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Short Form 36 Health Survey(SF-36)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hospital for Special Surgery Knee Score Scale(HSS)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

null

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)：

Subjects will be assigned according to a computer-generated table of random numbers and will be randomly assigned to 3 groups by an independent person who is unaware of the purpose of the experiment and the recruitment process.

Blinding：

Outcome assessors remained blinded in the process of implementation.

IPD sharing：

No

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

Not stated

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

CRF

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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