Investıgatıon of The Effıciency of Pulsed Electromagnetıc Field Therapy and Stretching Exercises
Primary Purpose
Muscle Injury, Pulsed Electromagnetic Therapy, Muscle Stretching Exercise
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Pulsed Electromagnetic Field Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Injury focused on measuring Muscle Injury, TGF-Beta 1, Fibrosis
Eligibility Criteria
Inclusion Criteria: Healthy young wistar albino rats Exclusion Criteria: not having any injury
Sites / Locations
- SuleymanDU
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control
Stretching Exercise
Pulsed Electromagnetic Field
Pulsed Electromagnetic Field and Stretching Exercise
Arm Description
Outcomes
Primary Outcome Measures
Mononuclear cell infiltration, Atrophy and necrosis, Pyknotic nucleus assesment at the end of two weeks
hematoxylin-eosin staining
VEGF and FGF assesment at the end of two weeks
immunohischemical staining
TGF-β1, eNOS assesment at the end of two weeks
Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-qPCR)
Secondary Outcome Measures
Full Information
NCT ID
NCT05988476
First Posted
August 4, 2023
Last Updated
August 4, 2023
Sponsor
Suleyman Demirel University
1. Study Identification
Unique Protocol Identification Number
NCT05988476
Brief Title
Investıgatıon of The Effıciency of Pulsed Electromagnetıc Field Therapy and Stretching Exercises
Official Title
Investigation of The Efficiency of Pulsed Electromagnetic Field Treatment and Stretching Exercise In Experimental Skeletal Muscle Injury Model
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
October 2, 2022 (Actual)
Study Completion Date
November 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suleyman Demirel University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Injury, Pulsed Electromagnetic Therapy, Muscle Stretching Exercise
Keywords
Muscle Injury, TGF-Beta 1, Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Stretching Exercise
Arm Type
Experimental
Arm Title
Pulsed Electromagnetic Field
Arm Type
Experimental
Arm Title
Pulsed Electromagnetic Field and Stretching Exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
5 day/week, two week, one session stretching exercises consisting of ten repetitions of one minute
Intervention Type
Device
Intervention Name(s)
Pulsed Electromagnetic Field Therapy
Intervention Description
5 day/week, two week,two sessions consisting of 180 minutes
Primary Outcome Measure Information:
Title
Mononuclear cell infiltration, Atrophy and necrosis, Pyknotic nucleus assesment at the end of two weeks
Description
hematoxylin-eosin staining
Time Frame
two week
Title
VEGF and FGF assesment at the end of two weeks
Description
immunohischemical staining
Time Frame
two week
Title
TGF-β1, eNOS assesment at the end of two weeks
Description
Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-qPCR)
Time Frame
two week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy young wistar albino rats
Exclusion Criteria:
not having any injury
Facility Information:
Facility Name
SuleymanDU
City
Isparta
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investıgatıon of The Effıciency of Pulsed Electromagnetıc Field Therapy and Stretching Exercises
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