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Evaluation of clinical effect of Wei's traumatology manipulation on knee osteoarthropathy

Registration number：

ITMCTR2024000469

Date of Last Refreshed on：

2024-09-24

Date of Registration：

2024-09-24

Registration Status：

Prospective registration

Public title：

Evaluation of clinical effect of Wei's traumatology manipulation on knee osteoarthropathy

English Acronym：

Scientific title：

Evaluation of clinical effect of Wei's traumatology manipulation on knee osteoarthropathy

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Zhang jinlin

Study leader：

Zhang jinlin

Applicant telephone：

18121263393

Study leader's telephone：

18121263393

Applicant Fax：

Study leader's fax：

Applicant E-mail：

105596709@qq.com

Study leader's E-mail：

105596709@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

999 Hope Road Jiading District Shanghai

Study leader's address：

999 Hope Road Jiading District Shanghai

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Approved by ethic committee：

Approved No. of ethic committee：

（2024）临伦审第（38）号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of human research Project Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Date of approved by ethic committee：

2024/5/11 0:00:00

Contact Name of the ethic committee：

Wang Yifeng

Contact Address of the ethic committee：

No. 197 Ruijin Second Road Shanghai

Contact phone of the ethic committee：

021-64370045

Contact email of the ethic committee：

ruijincrc@126.com

Primary sponsor：

The Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Primary sponsor's address：

No. 197 Ruijin Second Road Shanghai

Secondary sponsor：

Country：

China

Province：

Shanghai

City：

Institution
hospital：

The Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Address：

No. 197 Ruijin Second Road Shanghai

Source(s) of funding：

Science Innovation Action Plan

Target disease：

Knee osteoarthritis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

Objective: To evaluate the functional improvement of patients with knee arthrosis treated with Weil manipulation by comparing the Lysholm score before and after treatment. Secondary objectives: 1. To evaluate the changes of VAS score muscle tone around knee joint and knee pain point threshold after manual treatment; 2.Explore the mechanism of manipulative treatment to improve the dysfunction of knee arthropathy patients.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1: In accordance with the diagnostic criteria including clinical signs and imaging data the diagnostic criteria of traditional Chinese medicine: refer to the "Guiding Principles of Clinical Research on New Chinese Medicine for the Treatment of osteoarthropathy" of the "Guiding Principles of Clinical Research on New Chinese Medicine" 2: Diagnostic criteria for Western medicine: The diagnostic criteria for knee osteoarthropathy formulated by the Rheumatology Branch of the Chinese Medical Association (2010) and the Kellgren-Lawrence imaging grade was 1-3 3: Sign a dated informed consent form commit to follow the study procedures and cooperate with the entire study process.The age range is 30-70 years old.

Exclusion criteria：

1: 1. Can not cooperate with the completion of data collection or incomplete data 2: 2. Patients with malignant tumors 3: 3. Patients diagnosed with suppurative arthritis gout or acute knee trauma 4: 4. Patients with a history of knee fracture 5: 5. Patients with poor treatment compliance 6: Other experimental studies for the treatment of this disease are being conducted within 6.2 weeks

Study execute time：

From 2024-01-31

To      2025-12-31

Recruiting time：

From 2024-10-01

To      2025-06-30

Interventions：

42

Group：

control group

Sample size：

Intervention：

infrared therapy

Intervention code：

42

Group：

treatment group

Sample size：

Intervention：

manipulation，infrared therapy

Intervention code：

Total sample size ： 84

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Institution/hospital：

The Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Level of the institution：

Grade IIIA hospital

Outcomes：

Outcome：

Tender point assessment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Assessment of muscle tissue status

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

visual analogue scale（VAS）

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Lysholm Knee Score Scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

none

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

30
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)：

Using simple randomization the research team members (Xue Bin and Yan Wei)obtained random numbers by using Excel software prepared random number cards sealed the envelopes with numbers on the envelopes and selected the corresponding numbered envelopes according to the order of enrollment. Eligible subjects were divided into groups according to the random numbers on the cards in the envelopes

Blinding：

IPD sharing：

Yes

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

Publication time: within 6 months after the publication of the research results; Disclosure mode: mesman platform(www.medresman.org); The sharing method is: ask researchers for

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

Case-report forms were used to collect and manage data

Data Managemen Committee：

Not yet

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

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