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Observational Study on the Efficacy of Silver Needle Pre-Release Combined with Sedation and Analgesia in the Manipulative Release of adhesive capsulitis

Registration number：

ITMCTR2024000366

Date of Last Refreshed on：

2024-09-03

Date of Registration：

2024-09-03

Registration Status：

Retrospective registration

Public title：

Observational Study on the Efficacy of Silver Needle Pre-Release Combined with Sedation and Analgesia in the Manipulative Release of adhesive capsulitis

English Acronym：

Scientific title：

Observational Study on the Efficacy of Silver Needle Pre-Release Combined with Sedation and Analgesia in the Manipulative Release of adhesive capsulitis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Guanghui Zhang

Study leader：

Guanghui Zhang

Applicant telephone：

372499021@qq.com

Study leader's telephone：

+86 159 6003 6903

Applicant Fax：

Study leader's fax：

Applicant E-mail：

372499021@qq.com

Study leader's E-mail：

372499021@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

566 Shengguang Road Jimei District Xiamen City Fujian Province Chi

Study leader's address：

566 Shengguang Road Jimei District Xiamen City Fujian Province China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Xiamen Medical University Affiliated Second Hospital

Approved by ethic committee：

Approved No. of ethic committee：

2024127

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Xiamen Medical College

Date of approved by ethic committee：

2024/7/8 0:00:00

Contact Name of the ethic committee：

Teaching and Research Management Department of the Second Affiliated Hospital of Xiamen Medical College

Contact Address of the ethic committee：

566 Shengguang Road Jimei District Xiamen City Fujian Province China

Contact phone of the ethic committee：

+86 592 615 9592

Contact email of the ethic committee：

372499021@qq.com

Primary sponsor：

Xiamen Medical University Affiliated Second Hospital

Primary sponsor's address：

566 Shengguang Road Jimei District Xiamen City Fujian Province China

Secondary sponsor：

Country：

China

Province：

Fujian

City：

Institution
hospital：

Xiam Medical University Affiliated Second Hospital

Address：

566 Shengguang Road Jimei District Xiamen City Fujian Province China

Source(s) of funding：

applying

Target disease：

adhesive capsulitis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

This study aims to explicitly evaluate the clinical efficacy of silver needle pre-release combined with sedation and analgesia in the manipulative release of adhesive capsulitis. By conducting a comparative analysis of patients' shoulder joint mobility pain levels and sleep quality before and after treatment the objective is to determine the effectiveness of this therapeutic approach in alleviating pain improving function and enhancing quality of life thereby providing a scientific basis for the clinical management of adhesive capsulitis

Description for medicine or protocol of treatment in detail：

Inclusion criteria

Age Range: Participants must be between 45 and 70 years of age. Duration of Symptoms: The duration of shoulder pain or stiffness must be more than 1 month. Absence of Severe Underlying Diseases: No history of severe cardiac disease. No history of neurological disorders. No history of coagulation dysfunction or other relevant hematological disorders. Voluntary Participation and Informed Consent: Participants must voluntarily agree to participate in the study and sign an informed consent form indicating their understanding of the study's objectives procedures potential risks and benefits.

Exclusion criteria：

(1) shoulder joint X-ray examination excludes patients with shoulder fractures and dislocations MRI examination excludes patients with rotator cuff injuries of grade three or above and excludes patients with tendon ruptures; (2) Patients who have received invasive treatment for other shoulder injuries within the past half month; (3) Shoulder pain caused by other reasons; (4) Patients with local skin infections in the treatment area as well as those with hematological and psychiatric disorders who cannot cooperate with treatment and have contraindications for invasive procedures

Study execute time：

From 2024-07-15

To      2024-12-31

Recruiting time：

From 2024-07-15

To      2024-12-31

Interventions：

15

Group：

control group

Sample size：

Intervention：

sedation and analgesia for manual release

Intervention code：

15

Group：

Experimental group

Sample size：

Intervention：

Silver needle pre release combined with sedation and analgesia for manual release

Intervention code：

Total sample size ： 30

Countries of recruitment
and research settings：

Country：

China

Province：

Fujian

City：

Institution/hospital：

Xiamen Medical University Affiliated Second Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Medication

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

range of motion

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Sleep rating

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

NRS

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

serum

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

45
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)：

none

Blinding：

IPD sharing：

No

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

not shared

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

not shared

Data Managemen Committee：

Not yet

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

back
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