Shear wave elastography assessment of hamstring muscle stiffness pre- and post Stretching and strengthening exercise training in patients with tight hamstring muscle
To assess hamstring muscle stiffness using shear wave elastography before and after stretching and strengthening exercise training in patients with tight hamstring muscles.
Design
Shear wave elastography will use to evaluate hamstring stiffness at baseline, 4 weeks and 12 weeks
Range of motion will measure with a goniometer
Muscle strength will assess with a handheld dynamometer
Measurements will perform twice per muscle and averaged
Settings and conduct
Measurement locations will confirm using an ultrasound transducer to show the shear elastic modulus in the region of interest with stable color distribution.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Clinical examination by a physical medicine and rehabilitation specialist
Goniometry to measure hip flexion and knee extension angles
Age range: 20-40 years
Exclusion Criteria:
Any underlying joint disease in the hip and knee
ROM disorders due to pain, such as radiculopathies and muscle problems
Currently participating in sports competitions
Cardiovascular disease or other serious systemic illness
Lower limb stretching or strengthening exercises in the past 6 months
Previous knee or hip surgery
Old fractures or presence of cysts/blocks in the thigh or le
Intervention groups
Patients will undergo baseline ultrasound to measure muscle elasticity. They then will receive supervised hamstring stretching and strengthening exercises 3 times/week for 3 months under a rehabilitation specialist.
Main outcome variables
The main outcome will change in hamstring muscle stiffness measured by shear wave elastography. Secondary outcomes will include range of motion, muscle strength, and patient-reported functional outcomes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240425061570N1
Registration date:2024-06-01, 1403/03/12
Registration timing:registered_while_recruiting
Last update:2024-06-01, 1403/03/12
Update count:0
Registration date
2024-06-01, 1403/03/12
Registrant information
Name
Leila Aghaghazvini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 1000
Email address
aghaghazvini.leila@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-18, 1403/02/29
Expected recruitment end date
2025-05-19, 1404/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Shear wave elastography assessment of hamstring muscle stiffness pre- and post Stretching and strengthening exercise training in patients with tight hamstring muscle
Public title
Shear wave elastography assessment of hamstring muscle stiffness pre- and post Stretching and strengthening exercise training in patients with tight hamstring muscle
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical examination by a physical medicine and rehabilitation specialist (esteemed faculty of Tehran University of Medical Sciences)
Goniometry and measurement of the angle between leg and femur in hip joint flexion and knee joint extension
Exclusion criteria:
Any underlying joint disease in the hip and knee joints
ROM disorders due to pain in conditions such as radiculopathies and muscular problems
Currently participating in sports competitions
Cardiovascular disease or any other serious systemic disease.Strengthening
exercises on the lower limbs in the past 6 months
Previous knee or hip surgery
Old fractures or the presence of a cyst or block in the thigh or shin
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:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shariati hospital Tehran University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Sixth Floor, Central Organization of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419943471
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
IR.TUMS.SHARIATI.REC.1402.078
Health conditions studied
1
Description of health condition studied
Patients with tight hamstring muscle problem
ICD-10 code
G71
ICD-10 code description
Primary disorders of muscles
Primary outcomes
1
Description
Range of motion is measured using a goniometer, and muscle strength is evaluated using a hand-held dynamometer. Functional outcomes reported by participants will also be assessed using the Lower Extremity Functional Scale (LEFS).
Timepoint
Sonoelastography is used to evaluate hamstring muscle stiffness at the beginning, 4 weeks and 12 weeks.
Method of measurement
Findings The participant lies on his stomach and his knee is bent to 90 degrees and the ultrasound probe is placed longitudinally on the hamstring muscles. Shear elastic modulus of ST, SM and BF muscles in dominant leg using ultrasound shear waves with Aixplorer device; SuperSonic Imagine is measured. Measurement sites were defined as the midpoint of the femur from the greater trochanter to the medial epicondyle for the ST and SM muscles, and to the lateral epicondyle of the femur for the BF muscle. These anatomical points are confirmed by palpation and B-mode images. An ultrasound transducer was placed at the measurement sites, parallel to the direction of the muscle fibers as determined by tracking multiple fascicles without interruption across the B-mode image. For each muscle, images were taken after the transducer was held at the measurement site for approximately 5 seconds until To confirm that the shear elastic modulus in the desired area of color distribution shows stability. Measurements will be performed twice for each muscle and the average values will be used for statistical analysis. The target region is set near the center of the muscle bulk image, and the average shear wave propagation speed (m/s) of a circle with a diameter of 11 mm, which is set near the center of the target region, will be automatically calculated.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Under the supervision of a respected specialist in physical medicine and rehabilitation, for three months, three times a week, patients undergo exercise treatments, including strengthening and stretching exercises for the hamstring muscles. The stretching part of the exercises focuses on static stretching (passive single leg raise, Hurdler stretch and knee to chest), while the strengthening part includes exercises such as wall squat, bridge and lunge.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Leila Aghaghazvini
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
Aghaghazvini.leila@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Vice Chancellor for Research and Technology, Sixth Floor, Central Organization of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Leila Aghaghazvini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
Aghaghazvini.leila@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila Aghaghazvini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
Aghaghazvini.leila@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila Aghaghazvini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
Aghaghazvini.leila@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
After printing the results as an article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For further research purposes and analysis
From where data/document is obtainable
In order to receive the data, it is necessary to refer to the scientific accountant or the corresponding author of the article
What processes are involved for a request to access data/document