TECAR therapy and myofascial stretch on iliotibial band flexibility and functional activity
Design
Two arm parallel group randomised trial with single-blinded and outcome assessment
Settings and conduct
The study is performed as a one-way blind and the participants are not informed about the type of treatment. This study is performed to obtain more information to increase efficiency and improve the treatment process in athletes.
The modality of TECAR therapy as a device to accelerate the process of soft tissue flexibility is compared with the routine method and this study is implemented among volunteers and semi-professional athletes in Qom province.
Participants/Inclusion and exclusion criteria
1. The person has no iliotibial band clinical signs
2. The person is in the age range of 20 to 40 years
3. Unilateral or bilateral confirmation of shortness in the iliotibial band using ober test
exclusion criteria:
1- Surgery in the last three months
2 - Severe structural disorders such as genu varum
3. Balance disorder
4- Using assistive devices
Intervention groups
The comparison group includes eligible individuals (positive Ober test) who receive stretch intervention and receive a TECAR therapy with the device turned off.
The intervention group is eligible individuals (positive Ober test) who receive stretch intervention and TECAR therapy.
Main outcome variables
-Iliotibial band flexibility
-Jump on one foot
-vertical jump
-Hip abductor muscle strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210804052081N1
Registration date:2021-08-27, 1400/06/05
Registration timing:registered_while_recruiting
Last update:2021-08-27, 1400/06/05
Update count:0
Registration date
2021-08-27, 1400/06/05
Registrant information
Name
zeinab sheikhshoaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3288 0994
Email address
shoaee.pt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-10, 1400/05/19
Expected recruitment end date
2021-09-20, 1400/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of TECAR therapy and myofascial stretch on iliotibial band flexibility and functional activity in semi elite athletes
Public title
TECAR therapy and myofascial stretch on iliotibial band flexibility and functional activity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be a semi-professional athlete
The person has no iliotibial band clinical signs
Unilateral or bilateral confirmation of shortness in the iliotibial band using test
Exclusion criteria:
Previous surgical history in the last 3 months in any of the musculoskeletal structures
People who have had surgery more than twice
Structural and postural disorders such as severe kyphosis or scoliosis in the individual
Having uncorrected vision disorders
Neurological disorders
Respiratory and vestibular diseases
Use of any medications or substances that affect balance
Structural disorders in the pelvis and lower limbs that affect a person's balance
Use walking aids such as a cane
The person has rheumatic disease
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients are not aware of the treatments, for the treatment group, the device is used with predefined settings, and for the control group, the probe is used to turn off the device. But the therapist is aware of group therapy.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Mirdamad, Shah Nazari St., Maddakaran Alley, Iran School of Rehabilitation, Iran
City
tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Approval date
2021-07-16, 1400/04/25
Ethics committee reference number
IR.IUMS.REC.1400.335
Health conditions studied
1
Description of health condition studied
Semi-professional athletes with iliotibial band shortening
ICD-10 code
Y93.79
ICD-10 code description
Activity, other specified sports and athletics
Primary outcomes
1
Description
Iliotibial band flexibility
Timepoint
Before the intervention - after the first week of the intervention - the second week and the third week after the intervention
Method of measurement
Use of goniometer
2
Description
abductor muscle strength
Timepoint
Before the intervention - after the first week of the intervention - the second week and the third week after the intervention
Method of measurement
manual muscle test
Secondary outcomes
1
Description
one leg jump
Timepoint
Before the intervention and third week after the intervention
Method of measurement
tape measure
2
Description
vertical jump
Timepoint
Before the intervention and third week after the intervention
Method of measurement
tape measure
Intervention groups
1
Description
Intervention group: In this group, the stretching technique mentioned in the article is performed four times by the therapist for the participants. The TECAR probe is then placed for 10 minutes in capacitive mode with settings of 800 bursts per second, 400-microsecond burst duration, 800-microsecond inter burst interval in the area where the tendon and gluteal muscles- fascia tensor connect to the area slightly above tibia gerdy's tubercle.
Category
Rehabilitation
2
Description
In this group, the stretching technique mentioned in the article is performed four times by the therapist for the participants. The TECAR probe is then placed for 10 minutes in the area where the tendon and gluteal muscles- fascia tensor connect to the area slightly above tibia gerdy's tubercle. In this group, the device is off.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharan Physiotherapy Clinic
Full name of responsible person
Zainab Sheikh Shoaee
Street address
Ghoum, Jomhory Blvd., Alley 60, No. 16
City
Ghoum
Province
Ghoum
Postal code
3716766367
Phone
+98 25 3288 0994
Email
shoaee.pt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
zainab sheikh shoaee
Street address
Mirdamad, Madar Square, Shah Nazari St., Maddakaran St.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 25 3288 0994
Email
shoaee.pt@gmail.com
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
Private
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
zeinab sheikh shoaee
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Mirdamad, Madar Square, Shah Nazari St., Maddakaran St.
City
tehran
Province
Tehran
Postal code
1545913487
Phone
+98 25 3288 0994
Email
shoaee.pt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
zeinab sheikh shoaee
Position
Master student of physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tehran, Mirdamad, Madar Square, Shah Nazari St., Maddakaran St., Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 25 3288 0994
Email
shoaee.pt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
zainab sheikh shoaee
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Mirdamad, Madar Square, Shah Nazari St., Maddakaran St.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 25 3288 0994
Email
shoaee.pt@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All potential data can be shared after individuals are unrecognizable
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
People who are also in the industry can apply for them
Under which criteria data/document could be used
Analysis is not allowed to prove unscientific claims. For example, device manufacturers do not have the right to use data to advance their goals.
From where data/document is obtainable
Email address
shoaee.pt@gmail.com
What processes are involved for a request to access data/document
starting the access period 6 months after printing the results and obtaining permission from the relevant project instructor and checking the honesty in using the documents in less than 3 weeks will provide the applicant with the files.