Soft Tissue InjuriesNCT03365037
Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury
A study testing Electret electrostatic physiotherapyFilm and Fracture healing film in people with Soft Tissue Injuries, run by Peking University People's Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Soft Tissue Injuries
- What is being tested?
- Electret electrostatic physiotherapyFilm and Fracture healing film
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2012to 30 Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
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.
- Conditions
- Soft Tissue Injuries
- Being tested
- Electret electrostatic physiotherapyFilm, Fracture healing film
- Medical subject headings
- Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electret electrostatic physiotherapyFilmDrug
Also called polypropylene
Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm
Fracture healing filmDrug
Also called Teflon,2011-2640661
Patients with acute soft tissue injury treated with Fracture healing film
| Study group | Role | What they receive |
|---|---|---|
| Electret electrostatic physiotherapyFilm | Experimental | Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm Receives: Drug: Electret electrostatic physiotherapyFilm |
| Fracture healing film | Active comparator | Patients with acute soft tissue injury treated with fracture healing film Receives: Drug: Fracture healing film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cured persons
Pain, swelling, bruising and other symptoms and signs of integration to reduce more than 95%, the normal joint movement
Measured: 7 days after treatment (±2 days)
Secondary outcomes (1)
Number of adverse events
allergic skin rash
Measured: 7 days after treatment (±2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Apr 2012
- Primary completion30 Sep 2012
- Study completion30 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InjuriesStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Yichong, Peking University People's Hospital
- Investigators
- Peixun Zhang, Doctor, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365037
- Sponsor's protocol ID
- PKUPH20121030A
- Status last verified
- Dec 2017
- First submitted
- 25 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury
- ClinicalTrials.gov ID
- NCT03365037
- Acronym / sponsor ID
- PKUPH20121030A
- Conditions
- Soft Tissue Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 30 Sep 2012 (actual)
- Study completion
- 30 Sep 2012 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electret electrostatic physiotherapyFilm | Experimental | Drug: Electret electrostatic physiotherapyFilmPatients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm |
| Fracture healing film | Active comparator | Drug: Fracture healing filmPatients with acute soft tissue injury treated with fracture healing film |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electret electrostatic physiotherapyFilmAlso: polypropylenePatients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm | Drug | Electret electrostatic physiotherapyFilm |
| Fracture healing filmAlso: Teflon,2011-2640661Patients with acute soft tissue injury treated with Fracture healing film | Drug | Fracture healing film |
Primary outcome
Number of cured persons
Time frame: 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
1 secondary outcome
Number of adverse events
Time frame: 7 days after treatment (±2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peixun Zhang, Doctor study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electret electrostatic physiotherapyFilm and Fracture healing film in people with Soft Tissue Injuries, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cured persons (time frame: 7 days after treatment (±2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.