Clinical trial NCT03365037: Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury
Official title: Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Injuries
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, open, parallel controlled, non inferiority clinical trial design was used in this trial.Objective to evaluate the safety and effectiveness of electret static physiotherapy film in Beijing Youshilin science and Technology Development Co., Ltd.The patients were followed up after receiving the electret static physiotherapy film, and the treatment and complication rate of the patients were observed after the electret static physiotherapy film was attached to the patient.The data were compared between the experimental group and the control group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of cured persons
timeFrame: 7 days after treatment (±2 days)
Secondary outcomes:
measure: Number of adverse events
timeFrame: 7 days after treatment (±2 days)
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Peixun Zhang, Doctor
role: STUDY_CHAIR
References: