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A Clinical Study on Standardized Treatment of Tendinopathy by Synergy of Chinese and Western Medicine(part two)

Registration number：

ITMCTR2024000090

Date of Last Refreshed on：

2024-06-04

Date of Registration：

2024-06-04

Registration Status：

Prospective registration

Public title：

A Clinical Study on Standardized Treatment of Tendinopathy by Synergy of Chinese and Western Medicine(part two)

English Acronym：

Scientific title：

A Clinical Study on Standardized Treatment of Tendinopathy by Synergy of Chinese and Western Medicine(part two)

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Liuxiaohua

Study leader：

Liuxiaohua

Applicant telephone：

15210269577

Study leader's telephone：

15210269577

Applicant Fax：

Study leader's fax：

Applicant E-mail：

liuxiaohuabd01@sina.com

Study leader's E-mail：

liuxiaohuabd01@sina.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Wangjing Hospital, China Academy of Traditional Chinese Medicine, Chaoyang District, Beijing, China

Study leader's address：

Wangjing Hospital, China Academy of Traditional Chinese Medicine, Chaoyang District, Beijing, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Department of Sports Medicine, Wangjing Hospital, China Academy of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

WJEC-KT-2024-002-P002

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee, Wangjing Hospital, China Academy of Traditional Chinese Medicine, China

Date of approved by ethic committee：

2024/2/26 0:00:00

Contact Name of the ethic committee：

Wanghao

Contact Address of the ethic committee：

Wangjing Hospital of China Academy of Traditional Chinese Medicine, Huajiadi Street, Chaoyang District, Beijing, China

Contact phone of the ethic committee：

8473 9681

Contact email of the ethic committee：

peterxfx@126.com

Primary sponsor：

Wangjing Hospital, China Academy of Traditional Chinese Medicine

Primary sponsor's address：

Wangjing Hospital of China Academy of Traditional Chinese Medicine, Huajiadi Street, Chaoyang District, Beijing, China

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Chaoyang District

Institution
hospital：

Wangjing Hospital, China Academy of Traditional Chinese Medicine

Address：

Wangjing Hospital of China Academy of Traditional Chinese Medicine, Huajiadi Street, Chaoyang District, Beijing, China

Source(s) of funding：

Wangjing Hospital, China Academy of Traditional Chinese Medicine

Target disease：

Tendinopathy

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

For the conservative treatment of tendinopathy and the rehabilitation treatment after tendinopathy repair surgery, randomized controlled clinical trial studies are conducted to establish standardized Chinese and Western medicine combined treatment protocols, confirming their important role in the whole process of tendinopathy treatment and forming standardized Chinese and Western medicine combined treatment protocols. We will also promote its application to grassroots and community hospitals to provide more convenient and high-quality treatment methods. To provide theoretical basis for the important role of Chinese and Western medicine holistic treatment in sports injuries and their postoperative rehabilitation, so as to further enhance the level and service ability of Chinese medicine in postoperative treatment of sports injuries.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) met the diagnostic criteria; (2) 18 years old ≤ age ≤65 years old; (3) spoke fluently, were lucid, and could accurately evaluate and describe their discomfort; (4) signed an informed consent form; and (5) patients with Achilles tendon tendinopathy stops reconstructed or suture repaired.

Exclusion criteria：

(1) presence of heel fracture, infection, etc. in the affected limb; (2) flat feet, high arched feet, ankle inversion deformity, etc.; (3) keloid, allergy, or the presence of previous history of allergy to acupuncture or oral administration of traditional Chinese medicines; (5) patients with a history of previous tumors or joint specific and nonspecific synovial inflammatory disease; and (6) a BMI body mass index of more than 20% of the normal range.

Study execute time：

From 2023-11-01

To      2025-12-31

Recruiting time：

From 2024-06-07

To      2025-02-01

Interventions：

25

Group：

control subjects

Sample size：

Intervention：

Standardized rehabilitation

Intervention code：

25

Group：

experimental group

Sample size：

Intervention：

On the basis of standardized rehabilitation treatment, acupuncture and oral herbal medicine were added within 6 weeks after surgery.

Intervention code：

Total sample size ： 50

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Chaoyang District

Institution/hospital：

Wangjing Hospital, China Academy of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

signal/noise quotient, SNQ

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Leppilahti score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Laboratory indicators such as liver and kidney function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

American Orthopaedic Foot and Ankle Society, AOFAS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Karlsson score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Ankle proprioceptive recovery test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Visual analog scaleVAS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Randomization will take place directly after the baseline assessment by a person independent of the investigator using a computer-generated randomization sequence to be formed using SAS 9.4 software. Fifty envelopes will be prepared containing a description of the intervention to be performed. These envelopes will be sealed, then shuffled and sequentially numbered. Upon completion of the baseline assessment, a person independent of the study will select an opaque sealed envelope based on the randomized sequence formed. Subsequently, within 1 week, subjects will be treated with the treatment regimen contained in the envelope. The randomization code will not be revealed until the final follow-up measurement is completed (i.e., the participant's last visit) and data analysis is completed. Participants are instructed not to disclose their group assignment to the researcher during all measurements.

Blinding：

IPD sharing：

No

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

None

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

None

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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