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A clinical study protocol for Qihuang needle therapy for mid-term rehabilitation after shoulder sleeve repair surgery under arthroscopic surgery

Registration number：

ITMCTR2025000062

Date of Last Refreshed on：

2025-01-10

Date of Registration：

2025-01-10

Registration Status：

Retrospective registration

Public title：

A clinical study protocol for Qihuang needle therapy for mid-term rehabilitation after shoulder sleeve repair surgery under arthroscopic surgery

English Acronym：

Scientific title：

A clinical study protocol for Qihuang needle therapy for mid-term rehabilitation after shoulder sleeve repair surgery under arthroscopic surgery

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Jinyan Yu

Study leader：

Zhenhu Chen

Applicant telephone：

15761422356

Study leader's telephone：

13728063180

Applicant Fax：

Study leader's fax：

Applicant E-mail：

3306667853@qq.com

Study leader's E-mail：

chen@gzucm.edu.cn

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.16 Airport Road Guangzhou Guangdong China

Study leader's address：

No.16 Airport Road Guangzhou Guangdong China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China.

Approved by ethic committee：

Approved No. of ethic committee：

NO. JY2024-106

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee Teaching and Research Branch of the First Affiliated Hospital of Guangzhou University of Chinese Medicine

Date of approved by ethic committee：

2024/8/30 0:00:00

Contact Name of the ethic committee：

Huang Chunmei

Contact Address of the ethic committee：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China.

Contact phone of the ethic committee：

020-36585411

Contact email of the ethic committee：

530000739@qq.com

Primary sponsor：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China.

Primary sponsor's address：

No.16 Airport Road Guangzhou Guangdong China

Secondary sponsor：

Country：

China

Province：

Guangdong Province

City：

Guangzhou

Institution
hospital：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China.

Address：

No.16 Airport Road Guangzhou Guangdong China

Source(s) of funding：

State Administration of Traditional Chinese Medicine of the People's Republic of China(GZY-KJS-2022-026) Major Innovation Technology Construction Project of Synergistic Chinese Medicine and Western Medicine of Guangzhou (No.2023-2318)

Target disease：

Rehabilitation after rotator cuff injury repair

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

Exploring the clinical efficacy of qihuang needle therapy in patients undergoing mid-term rehabilitation after rotator cuff repair surgery

Description for medicine or protocol of treatment in detail：

Patients participating in the study continued to maintain their pre-enrollment medication regimen. Qihuang Acupuncture Group: Qihuang Acupuncture Therapy was given on top of the basic treatment. Control group: basic treatment (celecoxib capsules ultrasound physiotherapy joint release rehabilitation).

Inclusion criteria

(1) Meets the diagnostic criteria of Chinese and Western medicine for mid-term rehabilitation after rotator cuff repair; (2) Aged 18-70 years; (3) Arthroscopic rotator cuff repair performed by the same high-level surgeon of the team and the width of the rotator cuff before and after the rotator cuff tear was measured as a small to medium-sized rotator cuff tear (the size of the tear was 10-30 mm) during the operation; after the postoperative shoulder abduction brace was fixed routinely for 4 to 6 weeks the Magnetic Resonance Imaging (MRI) examination of the affected shoulder showed that the continuity of the tendon after rotator cuff repair was good. After 4-6 weeks of postoperative immobilization in a shoulder abduction brace magnetic resonance imaging (MRI) examination of the affected shoulder showed that the continuity of the tendon was good after rotator cuff repair but the patient still complained of pain and limitation of movement on the operated side of the shoulder and the VAS score of the pain in movement or pain at night was ≥30 mm with the limitation of the shoulder joint's active movement in abduction forward flexion and supination external rotation and posterior extension and internal rotation and with or without limitation of passive movement. (4) Voluntarily and cooperatively complete the treatment and collect clinical data; (5) Sign the informed consent form and accept regular follow-up.

Exclusion criteria：

(1) Preoperative diagnosis of combined calcific tendonitis; (2) Previous history of multiple surgeries on the affected shoulder; (3) Postoperative ulceration of the skin of the shoulder joint on the operated side infection trauma fracture dislocation. (4) Major underlying diseases such as mental cardiovascular and cerebrovascular diseases malignant tumors and blood diseases. (5) Have contraindications related to celecoxib such as gastrointestinal ulcers bleeding or perforation. (6) Have received postoperative acupuncture treatment. (7) Those who are also participating in other clinical trials; (8) Those who have contraindications to acupuncture are dizzy with needles or are unable to cooperate with acupuncture treatment. (9) Women who are pregnant or breastfeeding or are preparing for pregnancy.

Study execute time：

From 2023-11-30

To      2025-06-30

Recruiting time：

From 2024-08-30

To      2025-06-30

Interventions：

44

Group：

control subjects

Sample size：

Intervention：

basic treatment (celecoxib capsules ultrasonic physiotherapy joint mobilization and rehabilitation training).

Intervention code：

44

Group：

Qihuang needle group

Sample size：

Intervention：

basic treatment (celecoxib capsules ultrasonic physiotherapy joint mobilization and rehabilitation training) and Qihuang needle therapy treatment

Intervention code：

Total sample size ： 88

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong Province

City：

Guangzhou

Institution/hospital：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China.

Level of the institution：

Public hospital Grade A Level 3

Outcomes：

Outcome：

Visual pain simulation score

Type：

Primary indicator

Measure time point of outcome：

Before treatment 7 days after treatment followed up for 4 weeks

Measure method：

Ask patients about their subjective feelings

Outcome：

UCLA Shoulder Scoring System

Type：

Secondary indicator

Measure time point of outcome：

Before treatment 7 days after treatment followed up for 4 weeks Measure

Measure method：

Measured by the researcher and asked about the patient's subjective feelings

Outcome：

Modified Barthel Index Rating Scale (MBI)

Type：

Secondary indicator

Measure time point of outcome：

Before treatment 7 days after treatment followed up for 4 weeks

Measure method：

Ask patients about their subjective feelings

Outcome：

Constant-Murley Shoulder Scoring System UK

Type：

Secondary indicator

Measure time point of outcome：

Before treatment 7 days after treatment followed up for 4 weeks

Measure method：

Measured by the researcher and asked about the patient's subjective feelings

Outcome：

Shoulder mobility score

Type：

Primary indicator

Measure time point of outcome：

Before treatment 7 days after treatment followed up for 4 weeks

Measure method：

Measured by the researcher

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

18
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)：

A dedicated person is responsible for generating random numbers using SPPS 25.0 software dividing the numbers randomly by 1: 1 into the Qi Huang needle group and the control group and publishing the random distribution results through the network central randomization distribution system.

Blinding：

Due to the specific nature of the needling operation it is not possible to blind subjects and operators; third-party blinding is implemented i.e. those responsible for data collection evaluation of results and data analysis will not be aware of the grouping of patients. All procedures were performed according to established Standard Operation Procedure (SOP).

IPD sharing：

Yes

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

The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China.(http://www.gztcm.com.cn)

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

The case record table for this study can be detailed in the uploaded clinical research protocol PDF and the data management content can be viewed in detail on the website of the First Hospital of Guangzhou University of Chinese Medicine. All data will be uploaded and searchable when the trial is completed.

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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