Soft Tissue Injuries
Conditions
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.
Interventions
DRUGElectret electrostatic physiotherapyFilm
Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm
DRUGFracture healing film
Patients with acute soft tissue injury treated with Fracture healing film
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | 7 days after treatment (±2 days) | allergic skin rash |
Countries
China
Outcome results
None listed