Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2012
CompletedFirst Submitted
Initial submission to the registry
November 25, 2017
CompletedFirst Posted
Study publicly available on registry
December 7, 2017
CompletedDecember 7, 2017
December 1, 2017
6 months
November 25, 2017
December 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of adverse events
7 days after treatment (±2 days)
Study Arms (2)
Electret electrostatic physiotherapyFilm
EXPERIMENTALPatients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm
Fracture healing film
ACTIVE COMPARATORPatients with acute soft tissue injury treated with fracture healing film
Interventions
Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm
Patients with acute soft tissue injury treated with Fracture healing film
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peixun Zhang, Doctor
Peking University People's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 25, 2017
First Posted
December 7, 2017
Study Start
April 1, 2012
Primary Completion
September 30, 2012
Study Completion
September 30, 2012
Last Updated
December 7, 2017
Record last verified: 2017-12