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Therapeutic effect and mechanism of Sande technique combined with massage in the treatment of knee osteoarthritis with kidney deficiency and blood stasis

Registration number：

ITMCTR2200006579

Date of Last Refreshed on：

2022-09-09

Date of Registration：

2022-09-09

Registration Status：

Prospective registration

Public title：

Therapeutic effect and mechanism of Sande technique combined with massage in the treatment of knee osteoarthritis with kidney deficiency and blood stasis

English Acronym：

Scientific title：

Therapeutic effect and mechanism of Sande technique combined with massage in the treatment of knee osteoarthritis with kidney deficiency and blood stasis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200063523 ; ChiMCTR2200006579

Applicant：

Yan Zheng

Study leader：

Yan Zheng

Applicant telephone：

+86 18620817531

Study leader's telephone：

+86 18620817531

Applicant Fax：

Study leader's fax：

Applicant E-mail：

517177959@qq.com

Study leader's E-mail：

517177959@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

621 Gangwan Road, Huangpu District, Guangzhou City, Guangdong Province

Study leader's address：

621 Gangwan Road, Huangpu District, Guangzhou City, Guangdong Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The Fifth Affiliated Hospital of Guangzhou Medical University

Approved by ethic committee：

Approved No. of ethic committee：

GYWY-L2022-47

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the Fifth Affiliated Hospital of Guangzhou Medical University

Date of approved by ethic committee：

2022/5/6 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

The Fifth Affiliated Hospital of Guangzhou Medical University

Primary sponsor's address：

621 Gangwan Road, Huangpu District, Guangzhou City, Guangdong Province

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Institution
hospital：

The Fifth Affiliated Hospital of Guangzhou Medical University

Address：

621 Gangwan Road, Huangpu District, Guangzhou City, Guangdong Province

Source(s) of funding：

The Fifth Affiliated Hospital of Guangzhou Medical University

Target disease：

Knee osteoarthritis with kidney deficiency and blood stasis

Target disease code：

Study type：

Treatment study

Study design：

randomized controlled trial(parallel group design)

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

(1) To compare and analyze the clinical efficacy of Sande technique combined with meridian massage in the treatment of knee osteoarthritis with kidney deficiency and blood stasis. (2) To explore the molecular biology and biomechanical mechanism of Sande technique combined with meridian massage in the treatment of knee osteoarthritis with kidney deficiency and blood stasis.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① It conforms to the KOA diagnostic criteria of the Guidelines for Diagnosis and Treatment of osteoarthritis of the Chinese Society of Osteology, Chinese Medical Association (2007 edition), and conforms to the TCM dialectical classification of kidney deficiency and myeloid deficiency and blood stasis block in the Chinese Medicine Diagnostic and therapeutic Criteria for Diseases and Syndromes of Chinese Medicine. ② Age 50-85 years old; ③ X-ray KellgrenLawrence(K-L) classification in ⅰ-ⅲ; ④It can walk at least 10m without any auxiliary devices. ⑤ Volunteer to participate and cooperate to complete the study and sign the informed consent.

Exclusion criteria：

① Advanced osteoarthritis patients with severe knee deformity; ② Patients treated with cortisol hormone and analgesic drugs in the past month; ③ Patients with lower extremity surgery in the past 6 months; ④ Patients with diabetes, mental diseases, severe immunosuppressive diseases, blood diseases (coagulation disorders), infectious diseases, serious heart disease and liver and kidney dysfunction, rheumatoid arthritis, rheumatic immune arthritis, gout and Kaschin-Beck disease.

Study execute time：

From 2022-09-07

To      2023-05-06

Recruiting time：

From 2022-09-09

To      2023-05-06

Interventions：

20

Group：

Sample size：

Intervention：

Intervention code：

20

Group：

Sample size：

Intervention：

Intervention code：

20

Group：

Sample size：

Intervention：

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

City：

Institution/hospital：

Level of the institution：

Outcomes：

Outcome：

Baseline Information Collection

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

VAS score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Plantar pressure analysis

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Range of motion

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Infrared thermal imaging

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Osteoarthritis index

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Musculoskeletal ultrasound

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

50
Min age years
85
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

not applicable

Blinding：

IPD sharing：

No

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

not applicable

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

not applicable

Data Managemen Committee：

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

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