NCT05988476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 5, 2022

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

27 days

First QC Date

August 4, 2023

Last Update Submit

August 4, 2023

Conditions

Keywords

Muscle InjuryTGF-Beta 1Fibrosis

Outcome Measures

Primary Outcomes (3)

  • Mononuclear cell infiltration, Atrophy and necrosis, Pyknotic nucleus assesment at the end of two weeks

    hematoxylin-eosin staining

    two week

  • VEGF and FGF assesment at the end of two weeks

    immunohischemical staining

    two week

  • TGF-β1, eNOS assesment at the end of two weeks

    Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-qPCR)

    two week

Study Arms (4)

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: ExerciseDevice: Pulsed Electromagnetic Field Therapy

Interventions

5 day/week, two week, one session stretching exercises consisting of ten repetitions of one minute

Pulsed Electromagnetic FieldPulsed Electromagnetic Field and Stretching Exercise

5 day/week, two week,two sessions consisting of 180 minutes

Pulsed Electromagnetic Field and Stretching ExerciseStretching Exercise

Eligibility Criteria

Age10 Months - 11 Months
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy young wistar albino rats

You may not qualify if:

  • not having any injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SuleymanDU

Isparta, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Camurati-Engelmann SyndromeFibrosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

September 5, 2022

Primary Completion

October 2, 2022

Study Completion

November 7, 2022

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations