Muscle InjuryNCT05988476
Investıgatıon of The Effıciency of Pulsed Electromagnetıc Field Therapy and Stretching Exercises
A study testing Exercise and Pulsed Electromagnetic Field Therapy in people with Muscle Injury and Pulsed Electromagnetic Therapy, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
In this study, a total of 69 Wistar Albino rats were used, five of which were in the preliminary study. The preliminary study was planned to determine the ideal PEMF treatment time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF, INJ+Exercise+PEMF). Read more about this study
- Who is it for?
- Ages 10 to 11 months, women only
- Conditions the study is for
- Muscle Injury, Pulsed Electromagnetic Therapy, Muscle Stretching Exercise
- What is being tested?
- Exercise and Pulsed Electromagnetic Field Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2022to 7 Nov 2022
- 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 10 to 11 months
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Healthy young wistar albino rats
Who cannot join
- not having any injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of The Efficiency of Pulsed Electromagnetic Field Treatment and Stretching Exercise In Experimental Skeletal Muscle Injury Model
In this study, a total of 69 Wistar Albino rats were used, five of which were in the preliminary study. The preliminary study was planned to determine the ideal PEMF treatment time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF, INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the effects of the treatments. At the end of the experiment, genetic, histopathological, and immunohistochemical evaluations were made in the muscle tissue.
Read the detailed description
Purpose: The aim of this study was to evaluate the efficacy of stretching exercise and the pulsed electromagnetic field (PEMF) method in the treatment of muscle injury (INJ).
Methods: In this study, a total of 69 Wistar Albino rats were used, five of which were in the preliminary study. The preliminary study was planned to determine the ideal PEMF treatment time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF, INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the effects of the treatments. At the end of the experiment, genetic, histopathological, and immunohistochemical evaluations were made in the muscle tissue.
- Being tested
- Exercise, Pulsed Electromagnetic Field Therapy
- Keywords
- Muscle Injury, TGF-Beta 1, Fibrosis
- Medical subject headings
- Camurati-Engelmann Syndrome, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
5 day/week, two week, one session stretching exercises consisting of ten repetitions of one minute
Pulsed Electromagnetic Field TherapyDevice
5 day/week, two week,two sessions consisting of 180 minutes
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Stretching Exercise | Experimental | Not described Receives: Device: Pulsed Electromagnetic Field Therapy |
| Pulsed Electromagnetic Field | Experimental | Not described Receives: Other: Exercise |
| Pulsed Electromagnetic Field and Stretching Exercise | Experimental | Not described Receives: Other: Exercise; Device: Pulsed Electromagnetic Field Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mononuclear cell infiltration, Atrophy and necrosis, Pyknotic nucleus assesment at the end of two weeks
hematoxylin-eosin staining
Measured: two week
VEGF and FGF assesment at the end of two weeks
immunohischemical staining
Measured: two week
TGF-β1, eNOS assesment at the end of two weeks
Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-qPCR)
Measured: two week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start5 Sep 2022
- Primary completion2 Oct 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle InjuryStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut ERGAN, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988476
- Sponsor's protocol ID
- SuleymanDUmesutergan01
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Efficiency of Pulsed Electromagnetic Field Treatment and Stretching Exercise In Experimental Skeletal Muscle Injury Model
- ClinicalTrials.gov ID
- NCT05988476
- Acronym / sponsor ID
- SuleymanDUmesutergan01
- Keywords
- Muscle Injury, TGF-Beta 1, Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 2 Oct 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 14 Aug 2023 (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.
In this study, a total of 69 Wistar Albino rats were used, five of which were in the preliminary study. The preliminary study was planned to determine the ideal PEMF treatment time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF, INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the effects of the treatments. At the end of the experiment, genetic, histopathological, and immunohistochemical evaluations were made in the muscle tissue.
Detailed description
Purpose: The aim of this study was to evaluate the efficacy of stretching exercise and the pulsed electromagnetic field (PEMF) method in the treatment of muscle injury (INJ).
Methods: In this study, a total of 69 Wistar Albino rats were used, five of which were in the preliminary study. The preliminary study was planned to determine the ideal PEMF treatment time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF, INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the effects of the treatments. At the end of the experiment, genetic, histopathological, and immunohistochemical evaluations were made in the muscle tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Stretching Exercise | Experimental | Device: Pulsed Electromagnetic Field Therapy |
| Pulsed Electromagnetic Field | Experimental | Other: Exercise |
| Pulsed Electromagnetic Field and Stretching Exercise | Experimental | Other: Exercise, Device: Pulsed Electromagnetic Field Therapy |
Who may qualify
- Ages
- 10 to 11 months
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy young wistar albino rats
Key exclusion criteria (1 listed)
- not having any injury
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 |
|---|---|---|
| Exercise5 day/week, two week, one session stretching exercises consisting of ten repetitions of one minute | Other | Pulsed Electromagnetic Field, Pulsed Electromagnetic Field and Stretching Exercise |
| Pulsed Electromagnetic Field Therapy5 day/week, two week,two sessions consisting of 180 minutes | Device | Pulsed Electromagnetic Field and Stretching Exercise, Stretching Exercise |
Primary outcome
Mononuclear cell infiltration, Atrophy and necrosis, Pyknotic nucleus assesment at the end of two weeks
Time frame: two week
hematoxylin-eosin staining
VEGF and FGF assesment at the end of two weeks
Time frame: two week
immunohischemical staining
TGF-β1, eNOS assesment at the end of two weeks
Time frame: two week
Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-qPCR)
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 14 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Pulsed Electromagnetic Field Therapy in people with Muscle Injury and Pulsed Electromagnetic Therapy, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 14 Aug 2023. 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 Turkey (Türkiye). 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?
Mononuclear cell infiltration, Atrophy and necrosis, Pyknotic nucleus assesment at the end of two weeks (time frame: two week). The study lists 3 primary outcomes in all. 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 14 Aug 2023.