History
# Registration date Revision Id
2 2023-03-05, 1401/12/14 259706
1 2022-09-18, 1401/06/27 240670
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  • Protocol summary

    تاثير تکارتراپی بر درد، دامنه حرکتی و قدرت و خرده مقياسهای پرسشنامه مقياس ارزيابی ران و کشاله ران کپنهاگ در ورزشکاران با درد کشاله ناشی از کشيدگی عضلات اداکتور ران در فاز مزمن
    تاثير تکارتراپی بر درد، دامنه حرکتی و قدرت و خرده مقياسهای پرسشنامه مقياس ارزيابی ران و کشاله ران کپنهاگ در ورزشکاران با درد کشاله ناشی از عضلات اداکتور ران در فاز مزمن
    Include Criteria: Athletes with unilateral and chronic adductor muscle strain, Ability to read and write in Persian language, Age 18-45, Tenderness and Pain in resistance test, Pain at the beginning of the study should be 3-7؛ non include criteria: unwillingness to continue the treatment, Accompanying injuries, Referral Pain, Received treatment in the last 3 months, Contraindications for using TECAR
    Include Criteria: Athletes with unilateral and chronic adductor related groin pain, Ability to read and write in Persian language, Age 18-45, Tenderness and Pain in resistance test, Pain at the beginning of the study should be 3-7؛ non include criteria: unwillingness to continue the treatment, Accompanying injuries, Referral Pain, Received treatment in the last 1 months, Contraindications for using TECAR
    شرایط ورود: ورزشکاران با آسيب یکطرفه و مزمن کشيدگی عضلات اداکتور ران، توانايی خواندن و نوشتن به زبان فارسی، سن18-45، تندرنس و داشتن درد در حين انجام تست مقاومتی اداکتورهای ران، درد در ابتدای ورود افراد به مطالعه 3-7باشد؛ شرایط عدم ورود:عدم تمايل برای ادامه درمان،آسيبهای همراه، دردهای ارجاعی ، دريافت درمان در 3ماه اخير، موارد عدم کاربرد دستگاه تکارتراپی
    شرایط ورود: ورزشکاران با درد کشاله یکطرفه و مزمن ناشی از عضلات اداکتور ران، توانايی خواندن و نوشتن به زبان فارسی، سن18-45، تندرنس و داشتن درد در حين انجام تست مقاومتی اداکتورهای ران، درد در ابتدای ورود افراد به مطالعه 3-7باشد؛ شرایط عدم ورود:عدم تمايل برای ادامه درمان،آسيبهای همراه، دردهای ارجاعی ، دريافت درمان در 1 ماه اخير، موارد عدم کاربرد دستگاه تکارتراپی
    In the intervention group, the effectiveness of the TECAR on groin strain injury is investigated. In the control group, this device is used but with zero output intensity.
    In the intervention group, the effectiveness of the TECAR on adductor related groin pain is investigated. In the control group, this device is used but with zero output intensity.
    در گروه مداخله، اثربخشی دستگاه تکار بر آسیب کشیدگی کشاله ران بررسی میشود.در گروه کنترل نیز از این دستگاه اما با شدت خروجی صفر استفاده میگردد.
    در گروه مداخله، اثربخشی دستگاه تکار بر درد کشاله ناشی از عضلات اداکتور ران بررسی میشود.در گروه کنترل نیز از این دستگاه اما با شدت خروجی صفر استفاده میگردد.
  • General information

    empty
    Correction following preliminary study
    empty
    تصحیح به دنبال انجام مطالعه مقدماتی
    تاثیر تکارتراپی در ورزشکاران با درد کشاله ناشی از کشيدگی عضلات اداکتور ران در فاز مزمن
    تاثیر تکارتراپی در ورزشکاران با درد کشاله ناشی از عضلات اداکتور ران در فاز مزمن
    The Effects of TECAR Therapy on Pain, Range of Motion, Strength and Subscale of The Copenhagen Hip and Groin Outcome Scale Questionnaire in Athletes with Longstanding Adductor Related Groin Pain
    The Effects of TECAR Therapy on Pain, Range of Motion, Strength and Subscale of The Copenhagen Hip and Groin Outcome Scale Questionnaire in Athletes with Longstanding Adductor Related Groin Pain
    تاثير تکار تراپی بر درد ، دامنه حرکتی، قدرت و خرده مقياسهای پرسشنامه " مقياس ارزيابی ران و کشاله ران کپنهاگن" در ورزشکاران با درد کشاله ناشی از کشيدگی عضلات اداکتور ران در فاز مزمن
    تاثير تکار تراپی بر درد ، دامنه حرکتی، قدرت و خرده مقياسهای پرسشنامه " مقياس ارزيابی ران و کشاله ران کپنهاگن" در ورزشکاران با درد کشاله ناشی از عضلات اداکتور ران در فاز مزمن
    Athletes with Adductor Strain more than 3 Months
    Unilateral Injury of Adductor Muscles
    Ability to Read and Write in Persian language (Elementary First Period)
    Age 18-45
    Tenderness in Adductor Muscles
    Pain during Resistance Test of Adductor Muscles
    Pain at the Beginning of the Study Should be 3-7. (Based on Visual Analogue Scale)
    Diagnosis of Grade 1 or 2 Strain with the Approval of Sports Specialist Doctor
    Athletes with Adductor related groin pain, at least one month after the injury
    Unilateral Injury of Adductor Muscles
    Ability to Read and Write in Persian language (Elementary First Period)
    Age 18-45
    Tenderness in Adductor Muscles
    Pain during Resistance Test of Adductor Muscles
    Pain at the Beginning of the Study Should be 3-7. (Based on Visual Analogue Scale)
    Injury confirmation by a Sports Specialist Doctor
    ورزشکاران با آسیب کشیدگی عضلات اداکتور ران که مدت زمان آسیب بیشتر از سه ماه باشد
    درگیری یک‌طرفه عضلات اداکتور ران
    توانایی خواندن و نوشتن به زبان فارسی (ابتدایی دوره اول)
    سن 45-18
    داشتن حس درد در لمس تاندون اداکتورهای ران
    داشتن درد در حین انجام تست مقاومتی اداکتورهای ران
    درد در ابتدای ورود افراد به مطالعه 7-3 باشد.( براساس VAS )
    تشخیص کشیدگی سطح یک و دو با تایید پزشک متخصص ورزشی
    ورزشکاران با درد کشاله ناشی از عضلات اداکتور ران که حداقل یک ماه از وقوع آسیب گذشته باشد
    درگیری یک‌طرفه عضلات اداکتور ران
    توانایی خواندن و نوشتن به زبان فارسی (ابتدایی دوره اول)
    سن 45-18
    داشتن حس درد در لمس تاندون اداکتورهای ران
    داشتن درد در حین انجام تست مقاومتی اداکتورهای ران
    درد در ابتدای ورود افراد به مطالعه 7-3 باشد.( براساس VAS )
    تایید آسیب توسط پزشک متخصص ورزشی
    Unwillingness to Continue Treatment
    Suffering from Injuries and Fractures in the Lower Limbs in a Way that Prevents the Completion of the Treatment Process
    Urinary and Genital Infections
    Hernia (inguinal, femoral)
    Referral Pains to the Groin Area
    Malignant tumors
    Accompanying Problems in the Groin Area
    Received Treatment in the Last 3 Months
    Cases of Non-use of the TECAR Therapy Device Include Pregnancy, Tumor, Electrical Devices Placed Inside the Body Such as Cardiac Pacemaker, Fever, Having Transplanted Tissue.
    Unwillingness to Continue Treatment
    Suffering from Injuries and Fractures in the Lower Limbs in a Way that Prevents the Completion of the Treatment Process
    Urinary and Genital Infections
    Hernia (inguinal, femoral)
    Referral Pains to the Groin Area
    Malignant tumors
    Accompanying Problems in the Groin Area
    Received Treatment in the Last 1 Month
    Cases of Non-use of the TECAR Therapy Device Include Pregnancy, Tumor, Electrical Devices Placed Inside the Body Such as Cardiac Pacemaker, Fever, Having Transplanted Tissue.
    عدم تمایل فرد برای ادامه درمان
    ابتلا به آسیب‌ها و شکستگی‌ها در اندام تحتانی به گونه‌ای‌که مانع تکمیل فرایند درمان شود
    ابتلا به عفونت‌های ادراری و تناسلی
    ابتلا به هر گونه فتق (اینگوینال، فمورال)
    ابتلا به دردهای ارجاعی به ناحیه کشاله
    ابتلا به تومورهای بدخیم
    ابتلا به مشکلات همراه در ناحیه کشاله
    دریافت درمان در 3 ماه اخیر
    موارد عدم کاربرد دستگاه تکارتراپی شامل بارداری، تومور، وسایل الکتریکی کارگذاشته شده داخل بدن مانند ضربان ساز قلبی، تب، دارای بافت پیوند زده‌شده
    عدم تمایل فرد برای ادامه درمان
    ابتلا به آسیب‌ها و شکستگی‌ها در اندام تحتانی به گونه‌ای‌که مانع تکمیل فرایند درمان شود
    ابتلا به عفونت‌های ادراری و تناسلی
    ابتلا به هر گونه فتق (اینگوینال، فمورال)
    ابتلا به دردهای ارجاعی به ناحیه کشاله
    ابتلا به تومورهای بدخیم
    ابتلا به مشکلات همراه در ناحیه کشاله
    دریافت درمان در یک ماه اخیر
    موارد عدم کاربرد دستگاه تکارتراپی شامل بارداری، تومور، وسایل الکتریکی کارگذاشته شده داخل بدن مانند ضربان ساز قلبی، تب، دارای بافت پیوند زده‌شده
  • Health conditions studied

    #1
    درد کشاله ناشی از آسیب عضلات اداکتور
    درد کشاله ناشی از عضلات اداکتور

Protocol summary

Study aim
The Effects of TECAR Therapy on Pain, Range of Motion, Strength and Subscale of Hip and Groin Outcome Scale Questionnaire in Athletes with Longstanding Adductor Related Groin Pain
Design
Double blinded randomized control trial. Allocation of patients to intervention and control groups based on random blocking method. The arrangement of the blocks is done based on the randomization website. The sample size was estimated using GPower 3.1 software and considering 10% dropout of 22 people.
Settings and conduct
Treatment protocol including a ten-minute warm-up with a treadmill, therapy and finally three stretching exercises three times a week and ten sessions in total. The experimenter is not aware of the grouping and treatment in each group. Placebo group are not aware of the output intensity of the TECAR device, so the current research is a double-blind type. Interventions are performed in the physiotherapy clinic of the Faculty of Rehabilitation Sciences of Iran.
Participants/Inclusion and exclusion criteria
Include Criteria: Athletes with unilateral and chronic adductor related groin pain, Ability to read and write in Persian language, Age 18-45, Tenderness and Pain in resistance test, Pain at the beginning of the study should be 3-7؛ non include criteria: unwillingness to continue the treatment, Accompanying injuries, Referral Pain, Received treatment in the last 1 months, Contraindications for using TECAR
Intervention groups
In the intervention group, the effectiveness of the TECAR on adductor related groin pain is investigated. In the control group, this device is used but with zero output intensity.
Main outcome variables
Pain, Range of Motion, Strength, Quality of Life, Symptoms, Participation in physical activities, Physical function on daily living , Function on sports and recreational activities

General information

Reason for update
Correction following preliminary study
Acronym
IRCT registration information
IRCT registration number: IRCT20220622055250N1
Registration date: 2022-09-18, 1401/06/27
Registration timing: prospective

Last update: 2023-03-24, 1402/01/04
Update count: 1
Registration date
2022-09-18, 1401/06/27
Registrant information
Name
Sara Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
nazari.sara@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of TECAR Therapy on Pain, Range of Motion, Strength and Subscale of The Copenhagen Hip and Groin Outcome Scale Questionnaire in Athletes with Longstanding Adductor Related Groin Pain
Public title
The Effects of TECAR Therapy in Athletes with Longstanding Adductor Related Groin Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Athletes with Adductor related groin pain, at least one month after the injury Unilateral Injury of Adductor Muscles Ability to Read and Write in Persian language (Elementary First Period) Age 18-45 Tenderness in Adductor Muscles Pain during Resistance Test of Adductor Muscles Pain at the Beginning of the Study Should be 3-7. (Based on Visual Analogue Scale) Injury confirmation by a Sports Specialist Doctor
Exclusion criteria:
Unwillingness to Continue Treatment Suffering from Injuries and Fractures in the Lower Limbs in a Way that Prevents the Completion of the Treatment Process Urinary and Genital Infections Hernia (inguinal, femoral) Referral Pains to the Groin Area Malignant tumors Accompanying Problems in the Groin Area Received Treatment in the Last 1 Month Cases of Non-use of the TECAR Therapy Device Include Pregnancy, Tumor, Electrical Devices Placed Inside the Body Such as Cardiac Pacemaker, Fever, Having Transplanted Tissue.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients to intervention and control groups is based on simple random block method (block size of 4 and allocation ratio 1:1).In this way, at the end of all four samplings, the number of samples in both groups is equal .The arrangement of the blocks is done based on the randomization website between the number one and six
Blinding (investigator's opinion)
Double blinded
Blinding description
In the current research, the examiner is not aware of the allocation of patients in each group, and the people in the placebo group are not aware of the output intensity of the TECAR device, so the current research is a double-blind type.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Etichal committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-05-07, 1401/02/17
Ethics committee reference number
IR.IUMS.REC.1401.076

Health conditions studied

1

Description of health condition studied
Adductor Related Groin Pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
First session, session 6, session 10, After 1 month
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Range of Motion
Timepoint
First session, Session 6, Session 10, After 1 month
Method of measurement
Goniometer

2

Description
Strength
Timepoint
First session, Session 6, Session 10, After 1 month
Method of measurement
Dynamometer

3

Description
Quality of Life
Timepoint
First session, Session 6, Session 10, After 1 month
Method of measurement
The Copenhagen Hip and Groin Outcome Score Questionnaire

4

Description
Pain
Timepoint
First session, Session 6, Session 10, After 1 month
Method of measurement
The Copenhagen Hip and Groin Outcome Score Questionnaire

5

Description
Symptoms
Timepoint
First session, Session 6, Session 10, After 1 month
Method of measurement
The Copenhagen Hip and Groin Outcome Score Questionnaire

6

Description
Participation in physical activities
Timepoint
First session, Session 6, Session 10, After 1 month
Method of measurement
The Copenhagen Hip and Groin Outcome Score Questionnaire

7

Description
Function, sports and recreational activities
Timepoint
First session, Session 6, Session 10, After 1 month
Method of measurement
The Copenhagen Hip and Groin Outcome Score Questionnaire

8

Description
Physical function, daily living
Timepoint
First session, Session 6, Session 10, After 1 month
Method of measurement
The Copenhagen Hip and Groin Outcome Score Questionnaire

Intervention groups

1

Description
Intervention group: The people who are in this group will receive ten sessions treatment in three times a week. In this group, the TECAR device will be used with the aim of heating the tissues for 15 minutes and with 30-40 percent of intensity.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic, Faculty of Rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Soheil Mansour Sohani
Street address
Faculty of Rehabilitation Sciences of Iran Medical Sciences University, Madadkaran Street, Shah Nazari Street, Madder Square, Mirdamad
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
mansorsohani.s@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
hossein keyvani
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara Nazari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Mirdamad
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
Email
nazari.sara@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara Nazari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Mirdamad
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
Email
nazari.sara@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara Nazari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Mirdamad
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
Email
nazari.sara@iums.ac.ir

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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