The effect of Shockwaves Therapy on Lower Extremity Pain, Function and Torque Ratio of Abductors to Hip Adductors in Runners with Iliotibial Band Syndrome
Investigating the effect of shockwave therapy on pain, function and kinematics of lower limbs in runners with iliotibial band syndrome (ITBS)
• Determine the effect of actual (SWT) and sham SWT (sham-SWT) on pain in runners with ITBS
• Determining the effect of real SWT and sham-SWT on lower limb performance in runners with ITBS
• Determining the effect of actual SWT and sham-SWT on and ratio of abductors to hip adductors torque in runners with ITBS.
• Comparison of the effect of real SWT and sham-SWT on pain in runners with ITBS
• Comparison of the effect of real SWT and sham-SWT on lower limb performance in runners with ITBS
• Comparison of the effect of real SWT and sham-SWT on the torque ratio of abductors to hip adductors in runners with ITBS
Design
A controlled, parallel-group, double-blind, randomized clinical trial on 30 runners with ITBS. The intervention includes 2 times a week for 4 weeks of shockviotherapy
Settings and conduct
The study will be conducted on 30 people with ITBS who are runners of Semnan province athletics committee. People are randomly divided into two groups, and group 1 receives shock therapy twice a week along with routine physiotherapy for 4 weeks, and the sham control group receives shock therapy along with routine physiotherapy. Hip abductor and adductor torques, pain intensity and lower limb function will be evaluated before the intervention and after the last session of the intervention. The participant, the therapist and the evaluator are blind.
Participants/Inclusion and exclusion criteria
• Age between 18 and 50 years
• Regular runner
• Having pain of at least 4
• Diagnosis of ITBS
• Pain intensity
Noble's test positive
Intervention groups
Group 1) Shock wave therapy with routine physiotherapy Group 2) Sham shock therapy (control group) with routine physiotherapy
Main outcome variables
pain; performance; Torque ratio of abductors to hip abductors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230107057073N1
Registration date:2023-02-21, 1401/12/02
Registration timing:registered_while_recruiting
Last update:2023-02-21, 1401/12/02
Update count:0
Registration date
2023-02-21, 1401/12/02
Registrant information
Name
Esmaeil Tabbakhi bonab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4208
Email address
esmaeiltabbakhi1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Shockwaves Therapy on Lower Extremity Pain, Function and Torque Ratio of Abductors to Hip Adductors in Runners with Iliotibial Band Syndrome
Public title
the effect of shockwave therapy on pain and performance in runners with iliotibial band syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 50 years old
A runner with experience of more than one year and regular weekly training and participating in cross-country competitions and running at least 20 km per week
Having pain for at least 4 weeks in the lateral area of the knee
ITBS diagnosis based on history Clinical examination and modified treadmill test •
Pain intensity: grade 1 - pain after running, but does not limit the distance or speed of running. Grade 2 - pain while running but no limitation of running distance or speed. Grade 3 - Pain during running severe enough to limit distance or speed. and grade 4 - the pain is severe enough to prevent running. To continue with the baseline assessment, subjects had to report a pain grade of 3 or 4.
Positive Noble's test, if pain was present at 30 to 40 degrees of flexion when a finger was held on the lateral condyle of the knee during flexion/extension. It is experienced.
Exclusion criteria:
Symptoms of knee injury
Previous treatment of ITBS in the last 6 months
Use of painkillers or NSAIDs in the past two weeks
Use of hot pack and icepack
Stretching or weight lifting two days before
History of knee surgery
pregnancy
Using a heart battery
Taking anticoagulants
Fracture of damaged leg bones in the last 12 months
History of treatment with shock wave
infection
tumor
diabetes
Rheumatic disease
Severe heart disease
Psychiatric illness
Other severe systemic diseases
Unwillingness to accept any of the interventions in the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by lottery means that at the beginning of the study and in the first referring patient, the group names are written in 2 pieces of paper and placed in one of two intervention or control groups by the patient operator's removal. By identifying the first patient's treatment group, the next patient will be assigned to the other group and thus the patients will be divided into groups. In this study, the researcher, evaluator, and participants are unaware of the study group allocation and only the operator is aware of the group assignment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants enter the research after completing the informed consent form and are divided into two groups. From this stage, only the operator of the device has been informed from the medical group and the participants, the resarcher and the evaluator to avoid the bias in the study from the subjects of the study groups No information is available.
Placebo
Used
Assignment
Parallel
Other design features
Examples include athletes who are brought to the attention of sports federations, who will begin treatment with the approval of the center.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Before starting the study, immediately after treatment
Method of measurement
VAS
2
Description
Lower Extremity Function
Timepoint
Before starting the study, immediately after treatment
Method of measurement
modified treadmill
3
Description
Torque Ratio of Abductors to Hip Adductors
Timepoint
Before starting the study, immediately after treatment
Method of measurement
Isokinetic
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: It will be applied with 500 pulses with a frequency of 15 Hz in the selected area. Depending on the level of pain tolerance, it will increase up to 2000 pulses. Finally, 3 trigger points in the outer thigh area with 700 pulses and 15 Hz, twice a week for 4 weeks. Shockwave device: ESM, Swiss Dolorclast model, Swiss along with routine physiotherapy
Category
Treatment - Devices
2
Description
Control group: Sham shock therapy along with routine physical therapy. 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
Sports and Youth Department of Semnan Province
Full name of responsible person
Seyyed Mohammad Taghi Alavi
Street address
Semnan, Golestan town, Nagaristan Square, West Nagaristan Blvd., building number 2
City
Semnan
Province
Semnan
Postal code
۹۳۶۳۵۳۵۱۹۷
Phone
+98 23 3346 8026
Email
info@domain.com
Web page address
http://semnan.msy.gov.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminianfar
Street address
School of rehabilitation, Semnan University of Medical Sciences, 5 km of Semnan-Damghan road
City
Seman
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
School of rehabilitation, Semnan University of Medical Sciences, 5 km of Semnan-Damghan road
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of rehabilitation, Semnan University of Medical Sciences, 5 km of Semnan-Damghan road
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
School of rehabilitation, Semnan University of Medical Sciences, 5 km of Semnan-Damghan road
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of rehabilitation, Semnan University of Medical Sciences, 5 km of Semnan-Damghan road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
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
School of rehabilitation, Semnan University of Medical Sciences, 5 km of Semnan-Damghan road
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of rehabilitation, Semnan University of Medical Sciences, 5 km of Semnan-Damghan road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
aminfar@semums.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