Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury

Not Applicable

Completed

• Conditions: Soft Tissue Injuries
• Interventions: Drug: Fracture healing film; Drug: Electret electrostatic physiotherapyFilm

• Registration Number: NCT03365037
• Lead Sponsor: Peking University People's Hospital

Brief Summary

The aim of this study was to evaluate the efficacy and safety of electret static physiotherapy film developed by Beijing Youshilin science and Technology Development Co., Ltd., to treat acute soft tissue injury by sticking to the affected area

Detailed Description

Design of randomized, open, parallel controlled non inferiority clinical trial.A total of 60 patients were included in the trial, including 30 subjects in the experimental group and 30 subjects in the control group. The experimental disease was acute soft tissue closed injury.

Study Timeline

• Study Start: 2012-04-01
• Primary Completion: 2012-09-30
• Study Completion: 2012-09-30
• Study First Submitted: 2017-11-25
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-05
• Last Update Submitted: 2017-12-05
• Study First Posted: 2017-12-07
• Last Update Posted: 2017-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with acute soft tissue injury diagnosed by Western Medicine
• Ability to communicate well with the researcher and comply with the requirements of the validation
• Participants agreed to participate in the clinical validation and follow the validation program requirements, and signed the informed consent form

Exclusion Criteria

• There are important organs (heart and lung) serious disease history, or have autoimmune disease history, such as rheumatism, SLE, or have a history of immune dysfunction, such as suffering from aids
• Patients with cardiac pacemaker
• Patients with open wounds
• Pregnant and lactating women
• Patients with history of mental illness
• Participants participated in other medical device trials or drug clinical trials within three months
• The researchers believe that the participants who are not eligible for clinical validation should be considered
• Patients who need to be treated with drugs
• Patients requiring physical therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fracture healing film	Fracture healing film	Patients with acute soft tissue injury treated with fracture healing film
Electret electrostatic physiotherapyFilm	Electret electrostatic physiotherapyFilm	Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm

Primary Outcome Measures

Name	Time	Method
Number of cured persons	7 days after treatment (±2 days)	Pain, swelling, bruising and other symptoms and signs of integration to reduce more than 95%, the normal joint movement

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	7 days after treatment (±2 days)	allergic skin rash

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Peking, Beijing, China