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CompletedNCT03365037Updated Dec 7, 2017

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

An interventional study of Electret electrostatic physiotherapyFilm and Fracture healing film in Soft Tissue Injuries, sponsored by Peking University People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-12-07.

Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 7 months after the study started (first participant enrolled Apr 2012, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Soft Tissue Injuries

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03

In context

Soft Tissue Injuries

64 studies on the registry are indexed under Soft Tissue Injuries; 7 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 51 interventional studies indexed under Soft Tissue Injuries.

Browse Soft Tissue Injuries studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form

Exclusion criteria

Exclusion Criteria:

  • There are important organs (heart and lung) serious disease history, or have 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Electret electrostatic physiotherapyFilm

    Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm

    Drug: Electret electrostatic physiotherapyFilm

  • Active comparator
    Fracture healing film

    Patients with acute soft tissue injury treated with fracture healing film

    Drug: Fracture healing film

Interventions

  • DrugElectret electrostatic physiotherapyFilm

    Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm

    Also known as: polypropylene

  • DrugFracture healing film

    Patients with acute soft tissue injury treated with Fracture healing film

    Also known as: Teflon,2011-2640661

06

What researchers measure

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

    Time frame: 7 days after treatment (±2 days)

Secondary outcomes

  1. Number of adverse events

    allergic skin rash

    Time frame: 7 days after treatment (±2 days)

07

Study locations

1 site
  • Peking University People's Hospital
    Peking, Beijing 100044, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03365037
Responsible party
Zhang Yichong (Principal Investigator, Peking University People's Hospital) — Principal investigator
First posted
Dec 7, 2017
Start date
Apr 1, 2012
Primary completion
Sep 30, 2012
Completion
Sep 30, 2012
Last update
Dec 7, 2017

Study contacts

Peixun Zhang, Doctor
study chair · Peking University People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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