Study the Effect of Extracorporeal Shockwave Therapy on Iliotibial Band Thickness, Pain and lower limb function in Athletes with Iliotibial Band Friction Syndrome
The aim of this study is to investigate the effect of shock wave therapy on the thickness of the iliotibial band, pain and lower limb function in athletes with iliotibial band wear syndrome
Design
A randomized clinical trial with a control group with double-blind parallel groups is conducted on 42 patients, 21 of whom are the intervention group and 21 of whom are the control group
Settings and conduct
The study will be conducted on 42 people with iliotibial band syndrome. The people will be randomly divided into two intervention and control groups. The control group will receive routine physiotherapy three times a week for three weeks, and the control group will receive routine physiotherapy twice a week. They receive shock therapy for three weeks. In this study, the participants and the researcher are blinded
Participants/Inclusion and exclusion criteria
Randomized double blind clinical trial with parallel groups on 42 runners with iliotibial band syndrome twice a week for three weeks shockwave therapy
Intervention groups
Group 1) Shock wave therapy with routine physiotherapy Group 2) Sham shock therapy (control group) with routine physiotherapyکار
Main outcome variables
Pain and function of lower limbs and iliotibial band thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231217060447N1
Registration date:2024-01-22, 1402/11/02
Registration timing:prospective
Last update:2024-01-22, 1402/11/02
Update count:0
Registration date
2024-01-22, 1402/11/02
Registrant information
Name
Nooshin Rasekhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3251 6402
Email address
dr.nrasekhi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the Effect of Extracorporeal Shockwave Therapy on Iliotibial Band Thickness, Pain and lower limb function in Athletes with Iliotibial Band Friction Syndrome
Public title
Study the Effect of Extracorporeal Shockwave Therapy on Iliotibial Band Thickness, Pain and lower limb function in Athletes with Iliotibial Band Friction Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18_50 years
Runners with experience of more than one year and regular weekly training and participation in running competitions
Having pain at least 4 weeks in the lateral of the knee
Pain intensity between 4_7
Exclusion criteria:
Symptoms of knee injury
Previous treatment of Iliotibial band syndrome within the last six months
Pain intensity more than 7
Using of NSAIDs during the last two weeks
Using of hot pack and ice pack
Stretching or weight lifting for the previous two days
History of knee surgery
Pregnancy
Broken Leg bones affected in the last 12 months
History of treatment with Shock Wave
Tumor
Diabetes
Rheumatic disease
Severe Heart disease
Psychiatric disease
Unwillingness to accept any intervention in the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are assigned (to two groups) randomly and using the method of random permutation blocks with 6 blocks of 6, assigned to the two groups. In this method, A will represent the intervention group and B will represent the control group. In this way, the order of A and B interventions in the form of blocks from 1 to 6 is determined by the methodological consultant of the project, and is provided to the executive supervisor of the project, and the researcher obtains an assignment from the executive supervisor to assign each qualified person. The supervisor first selects the block using a random number generator (or dice roll) and then the eligible individuals are assigned to one of the two groups A or B in the order specified in the table (top to bottom). And the sequence of each item will be crossed out. It should be noted that if a block is selected based on random numbers that have already filled all 6 sequences, another random number will be selected again for that person.
Blinding (investigator's opinion)
Double blinded
Blinding description
After completing the informed consent form, the participants enter the research and are placed in two groups. At this stage, the machine operator knows about the people in the treatment groups, and the participants, the researcher, do not know about the people in the studied groups to avoid bias in the study.
Placebo
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
Semnan University of Medical Sciences and Health Services, Basij Boulevard ,Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.SEMUMS.REC.1402.232
Health conditions studied
1
Description of health condition studied
Iliotibial Band Syndrome
ICD-10 code
M76.3
ICD-10 code description
Iliotibial band syndrome
Primary outcomes
1
Description
Pain
Timepoint
Before starting the study and immediately after treatment
Method of measurement
According to Visual Analogue Scale (VAS )
2
Description
Lower Limbs Function
Timepoint
Before starting the study and immediately after treatment
Method of measurement
Knee Injury and Osteoarthritis Outcome Score (KOOS ) Questionnaire
3
Description
Iliotibial Band Thickness
Timepoint
Before starting the study and immediately after treatment
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, shock wave ESM device model EMS SWISS DOLORCLAST will be performed. First, the most painful area of the external femoral condyle of the patient will be evaluated using point touch. Then RSWT with 500 pulses in mJ/mm2 (2 Bar) 0.10 with a frequency of 15 Hz will be applied in the selected area. Depending on the level of pain tolerance, it will increase up to 2000 mJ/mm2 pulse (2 Bar) 0.10 to 0.40 mJ/mm2 (4 Bar). No local anesthesia will be used
Category
Treatment - Devices
2
Description
Control group: All people in the control group will receive the shockwave in the same position with the device turned on but in such a way that it does not shock their body. First, a few shocks below the receiving threshold and then the device turns off
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center ,Next To Nemat Bastani ,Quds Blvd , Semnan ,Iran
Full name of responsible person
Nooshin Rasekhi
Street address
Semnan University of Medical Sciences and Health Services , Basij Boulevard , Semnan , Iran
City
semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
dr.nrasekhi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Atefeh Aminianfar
Street address
Semnan University of Medical Sciences, Semnan-Damghan Road, 5th km
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
Aminfar@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr Atefeh Aminianfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences , Semnan-Damghan Road 5th km
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
aminfar@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Atefeh Aminianfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences and Health Services , Basij Boulevard , Semnan , Iran
City
semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
aminfar@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Atefeh Aminianfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences and Health Services , Basij Boulevard , Semnan , Iran
City
semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
dr.nrasekhi@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