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

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

Study Overview

• Status: Completed
• Conditions: Soft Tissue Injuries
• Intervention / Treatment: Drug: Electret electrostatic physiotherapyFilm; Drug: Fracture healing film

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electret electrostatic physiotherapyFilm; Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm	Drug: Electret electrostatic physiotherapyFilm; Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm; Other Names: polypropylene
Active Comparator: Fracture healing film; Patients with acute soft tissue injury treated with fracture healing film	Drug: Fracture healing film; Patients with acute soft tissue injury treated with Fracture healing film; Other Names: Teflon,2011-2640661

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	allergic skin rash	7 days after treatment (±2 days)

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Chair: Peixun Zhang, Doctor, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): September 30, 2012
• Study Completion (Actual): September 30, 2012

Study Registration Dates

• First Submitted: November 25, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Soft Tissue Injuries
• Other Study ID Numbers: PKUPH20121030A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No