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"Xuan Bi Rou Jin" electroacupuncture with Intra-articular injection of betamethasone for Tendinopathy

Registration number：

ITMCTR2024000628

Date of Last Refreshed on：

2024-10-30

Date of Registration：

2024-10-30

Registration Status：

Prospective registration

Public title：

"Xuan Bi Rou Jin" electroacupuncture with Intra-articular injection of betamethasone for Tendinopathy

English Acronym：

Scientific title：

"Xuan Bi Rou Jin" electroacupuncture with Intra-articular injection of betamethasone for Tendinopathy

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Jiang Yanfang

Study leader：

Wang Jianquan

Applicant telephone：

01082267610

Study leader's telephone：

01082267502

Applicant Fax：

01062010440

Study leader's fax：

01062010440

Applicant E-mail：

anthea_jiang@126.com

Study leader's E-mail：

wjqsportsmed@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

#49 North Garden Rd Haidian District

Study leader's address：

#49 North Garden Rd Haidian District

Applicant postcode：

100191

Study leader's postcode：

100191

Applicant's institution：

Peking University Third Hospital

Approved by ethic committee：

Approved No. of ethic committee：

（2024）医伦审第（495-04）号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Peking University Third Hospital Medical Research Ethic Committee

Date of approved by ethic committee：

2024/10/12 0:00:00

Contact Name of the ethic committee：

Xue Hong

Contact Address of the ethic committee：

General Office of Scientific Research Ethics Peking University Third Hospital 49 Huayuan Road North Haidian District Beijing

Contact phone of the ethic committee：

01082265573

Contact email of the ethic committee：

scidept@bjmu.deu.cn

Primary sponsor：

Peking University Third Hospital

Primary sponsor's address：

49 North Garden Road Haidian District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Peking University Third Hospital

Address：

49 North Garden Road Haidian District Beijing

Source(s) of funding：

"Extensive Collection & Harmony Integration Projects of Peking University Third Hospital

Target disease：

Tendinopathy

Target disease code：

Study type：

Observational study

Study design：

Cohort study

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

To compare the efficacy of Intra-articular injection of betamethasone with or without electroacupuncture for tendinopathy

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Age between 20 and 60 years old. 2. Patients diagnosed with Achilles tendinitis at the insertion site. Diagnostic criteria for Achilles tendinitis at the insertion site include: a. Symptoms localized within 7 cm above the posterior calcaneus. b. Pain at the Achilles tendon insertion site at exercise or weight-bearing activities. c. Local thickening of the Achilles tendon at the insertion site. d. Tenderness within 7 cm above the Achilles tendon insertion site. 3. No open wounds or skin ulcers.

Exclusion criteria：

1. Previous surgery or dry needle treatment on the affected area. 2. Presence of severe diseases related to the heart brain lungs liver or kidneys 3. History of injury on the same side of the lower limb that may affect functional assessment. 4. Infection tumor or osteomyelitis in the ankle joint. 5. Presence of diabetes ankylosing spondylitis psoriasis rheumatoid arthritis or other autoimmune diseases. 6. Acute injuries such as avulsion fracture or Achilles tendon rupture.

Study execute time：

From 2024-11-01

To      2026-12-31

Recruiting time：

From 2024-11-01

To      2025-12-31

Interventions：

96

Group：

Injection and Acupuncture

Sample size：

Intervention：

Intra-articular injection of betamethasone with electroacupuncture

Intervention code：

96

Group：

Injection group

Sample size：

Intervention：

Intra-articular injection of betamethasone

Intervention code：

Total sample size ： 192

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Peking University Third Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

recurrence

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Victoria Sports Assessment Institute-Achilles Tendinopathy

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

return to sports

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Foot and Ankle Ability Measure

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Tegner Activity Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Foot and Ankle Outcome Score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

X-ray and Ultrasound

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

not applicable

Tissue：

Fate of sample 

Others

Note：

Not yet recruiting

20
Min age years
60
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)：

metadata will be shared on https://chinacohort.bjmu.edu.cn/

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

paper CRF will be completed by the investigators and clinical coordinators. All data will be double checked and entered on REDCap.

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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