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The Effect of Adding Tecartherapy On routine physicalTherapy On Pain And Kinetic Changes In Runners With Medial Tibial Stress Syndrome

Protocol summary

Study aim
The effect of adding tecartherapy on routine physiotherapy on pain and kinetic changes in runners with medial tibial stress syndrome
Design
The study will be randomized, with a sample size of 40 people in parallel groups. Eligible patients will be randomly assigned to the intervention group and control group using the blocking method.
Settings and conduct
intervention group with tecar combined with routine physiotherapy which includes tens and ultrasound. A special training program that includes stretching and strengthening exercises and group B as a control group that receives only routine physiotherapy according to the protocol of the first group. This protocol will be used and the site of this project is the Faculty of Rehabilitation of Iran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: any gender, people aged 20-40 years, have a history of pain during exercise in the inner-posterior part of the tibia, and pain by touching the posterior-inner edge of the tibia is about 5 cm in place, Pain that occurs with exercise and occurs during and after exercise, the presence of pain in the dominant affected leg, subjects at least a week to suffer from this pain. Exclusion criteria: imbalance, middle ear disorder, current or previous radiological signs of a stress fracture or other type of fracture, local infection or osteomyelitis, tumor in the area, previous surgery on the same leg, previous use of tecartherapy to treat tibial medial stress syndrome, pregnancy, implanted pacemaker, skin disorder and numbness in the area.
Intervention groups
Two different treatment groups. The group treated with tecar therapy and the group treated with the usual physiotherapy.
Main outcome variables
Pain intensity, balance, kinetic changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220301054160N1
Registration date: 2022-04-08, 1401/01/19
Registration timing: prospective

Last update: 2022-04-08, 1401/01/19
Update count: 0
Registration date
2022-04-08, 1401/01/19
Registrant information
Name
Saeideh Babaeitabar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4450 8936
Email address
saeidehbabaei66@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-20, 1401/01/31
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Adding Tecartherapy On routine physicalTherapy On Pain And Kinetic Changes In Runners With Medial Tibial Stress Syndrome
Public title
The Effect of Adding Tecartherapy On routine physicalTherapy On Pain And Kinetic Changes In Runners With Medial Tibial Stress Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects of any gender People aged 20-40 years. Have a history of pain during exercise in the inner-posterior part of the tibia bone and the pain spreads by touching the posterior-inner edge of the tibia about 5 cm in place Existence of pain that occurs with exercise and occurs during and after exercise The presence of pain in the affected leg is predominan Have this pain for at least a week
Exclusion criteria:
Patients with current or previous radiological symptoms of stress fractures or other types of fractures Local infection or osteomyelitis in the same foot Tumor in the area Previous surgery on the same leg Previous use of tecartherapy to treat tibial internal stress syndrome. Pregnancy Disorder and numbness in the area Patients with balance disorders, patients with middle ear disorder
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients are randomly assigned to intervention and control groups by the block method. Random numbers 1 and 2 are produced using www. randomization.com, then are placed in sealed envelopes in order. When patients are referred, one envelope is opened in order. If the number in the envelope is 1, the patient enters the intervention group with tecartherapy and routine physiotherapy, and if the number is 2, patient enters the control group, which includes only routine physiotherapy.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical sciences
Street address
No5,Dehkade Olmpic Ave.Zibadasht Blv,Tehran Town
City
Tehran
Province
Tehran
Postal code
1485963635
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
IR.SEMUMS.REC.1400.343

Health conditions studied

1

Description of health condition studied
Medial Tibial Stress Syndrome
ICD-10 code
S86.89
ICD-10 code description
Other injury of other muscles and tendons at lower leg level

Primary outcomes

1

Description
Pain
Timepoint
In the first session and after the completion of 9 treatment sessions
Method of measurement
Visual scale of pain

2

Description
Measurement of ground reaction force
Timepoint
In the first session and after the completion of 9 treatment sessions
Method of measurement
Force plate

3

Description
Measuring the average displacement velocity
Timepoint
In the first session and after the completion of 9 treatment sessions
Method of measurement
Force plate

4

Description
Measure the amount of displacement
Timepoint
In the first session and after the completion of 9 treatment sessions
Method of measurement
Force plate

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Tecar treatment group, 9 sessions of tecar therapy, the total time of treatment with tecar intervention in this study will be 15 minutes, which will be used as 5 minutes in capacitive mode and 10 minutes in resistance mode, and with the usual physiotherapy treatment that is exactly the same.
Category
Treatment - Devices

2

Description
Control group: The routine physiotherapy treatment group consists of nine treatment sessions including sessions on a daily basis. 20 minutes of high frequency tens with a frequency of 100 Hz and a pulse duration of 40 microseconds will be used at the site of pain, followed by 3 minutes of 1MHz ultrasound with a 20% diode cycle at the site of pain.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic of Iran University
Full name of responsible person
Saeideh Babaeitabar
Street address
Nezam Ave,Madar Squre,Mirdamad
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
saeidehbabaei66@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rosita Hedayati
Street address
Semnan University of Medical Science,Basij Blv
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 912 609 0589
Email
info@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
saeideh Babaeitabar
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
saeideh Babaeitabar
Position
Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Science.Basij Blv
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 8999
Email
saeidehbabaei66@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
saeideh Babaeitabar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Semnan Univesity of Medical Science,Basij Blv
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 8999
Email
saeidehbabaei66@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
saeideh babaei tabar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
tehran
City
Tehran
Province
Tehran
Postal code
1234567891
Phone
+98 912 237 8380
Email
saeidehbabaei66@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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