Determining a more effective treatment method with longer lasting effects for treating hamstring strains in amateur athletes between dry needling and active muscle release.
Design
The clinical trial has two treatment intervention groups, with parallel groups, single-blind, randomized with block on 34 patients.
Settings and conduct
Eligible individuals, after being informed about the general treatment method and the purpose of the study, voluntarily fill out and sign the consent form. If they meet the inclusion criteria, they are randomly assigned to one of the treatment groups. Then, the initial characteristics and demographic information of the participants (including age, weight, height, gender, and body mass index) and pre-treatment evaluations are recorded by a trained assessor who is unaware of the study type. After this evaluation, a treatment session will be conducted by a trained therapist. Participants will also be re-evaluated immediately and 24 hours after the treatment by a trained assessor who is unaware of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria include male and female amateur athletes between the ages of 18 and 40 in Tehran who usually train three times a week or for a maximum of 6 hours per week; exclusion criteria include fear of needles and no orthopedic or neurological diseases.
Intervention groups
It includes two groups: active release and dry needling on the hamstring muscles of individuals.
Comparison of the immediate effect of dry needling and active release technique in amateur athletes with hamstring muscle shortness
Public title
comparison of the immediate effect of dry needling and active release technique in amateur athlete's posterior thigh muscle shortness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People between the ages of 18 and 40
People with hamstring shortness of 25 degrees or more
Regular exercise three times a week, for less than 6 hours, for at least 10 months
Exclusion criteria:
Having a history of orthopedic or neurological problems
Low back pain during the study
Having a history of surgery in the back, hip, or knee joints
Having a recent history of hamstring strain
Being in a group of contraindications to the use of dry needling or active release
Having upper or lower motor neuron injury
Having a lower limb length discrepancy of more than 10 mm
Experience of any injury to the lower extremities within the last three months
Women during menstruation
Needle's phobia
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment is performed using the Block Randomization method so that the number of participants in the two groups is balanced.
1. Determine the block size: Given that we have two groups in this study, the block size must be divisible by 2, which is the most common block size when we have two study groups, 4. From each block of 4, 2 people will be placed in Group A or the dry needling group and 2 people in Group B or the active release technique group.
2. All possible combinations for a block:
AABB, ABAB, ABBA, BBAA, BABA, BAAB
Since we want the total sample size of the study to be 34 people, 9 blocks will be randomly selected from all the permutations.
3. Allocation of individuals to blocks:
Each individual who enters the study is entered into the study based on the order of individuals in the selected block. For example, if the random block is AABB, the first two individuals enter group A and the second two individuals enter group B, and ultimately we will have two groups of 17 individuals.
Blinding (investigator's opinion)
Single blinded
Blinding description
Eligible individuals, after being informed about the general treatment method and the purpose of the study, voluntarily fill out and sign the consent form. If they meet the inclusion criteria, they are randomly assigned to one of the treatment groups. Then, the initial characteristics and demographic information of the participants (including age, weight, height, gender, and body mass index) and pre-treatment evaluations are recorded by a trained assessor who is unaware of the study type. After this evaluation, a treatment session will be conducted by a trained therapist. Participants will also be re-evaluated immediately and 24 hours after the treatment by a trained assessor who is unaware of the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Room 605, 6th Floor, Tehran University of Medical Sciences Headquarters Building, Keshavarz Blvd and Qods Street junction, Tehran
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2025-07-01, 1404/04/10
Ethics committee reference number
IR.TUMS.FNM.REC.1404.080
Health conditions studied
1
Description of health condition studied
Hamstring muscle shortness
ICD-10 code
S76
ICD-10 code description
Injury of muscle, fascia and tendon at hip and thigh level
Primary outcomes
1
Description
Hamstring muscle flexibility
Timepoint
Before, immediately and 24 hour after intervention
Method of measurement
Goniometer and active knee extension test
2
Description
Passive compliance
Timepoint
Before, immediately and 24 hour after intervention
Method of measurement
Calculation by formula
3
Description
Passive peak torque
Timepoint
Before, immediately and 24 hour after intervention
Method of measurement
Manual dynamometer
4
Description
Stretch tolerance
Timepoint
Before, immediately and 24 hour after intervention
Method of measurement
Goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Dry needling intervention group: This method is performed using disposable stainless steel needles (mm 0.3*60 DongBang). In this method, subjects are placed on the treatment table in a prone position, with their feet on the bed, and the hamstrings are needled at 3 points, each for 1 minute, using a rapid entry and exit technique in a conical shape. To standardize the approach and optimize the application of dry needling, points are needled approximately close to the movement points of the hamstring muscles. The first two points are at 30 and 60%, respectively, of a straight line drawn from the attachment of the ischial tuberosity to the long and short heads of the biceps femoris muscle and then to the head of the fibula. The third point is at 60% of a straight line extending from the ischial tuberosity (the attachment point of the semimembranosus and semitendinosus muscles) to the medial condyle of the femur.
Category
Rehabilitation
2
Description
Active release intervention group: Active release, compared to other manual therapies, is a unique technique in which the patient actively moves, while the therapist uses his or her hands to first palpate, then assess and release the soft tissue. In this method, the therapist encourages the patient to move actively by applying manual pressure to the affected areas, and the muscle is stretched from a short length to a long length. This combination of pressure and active movement helps to increase muscle flexibility. Steps: The patient lies prone on the bed, with the patient's feet hanging over the end of the bed. The therapist then finds the area of the muscle that is most tight by skin contact and palpation and applies gentle pressure to it. The patient bends and straightens their knee to stretch the muscle from its short length to its long length. This cycle is repeated five times.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy clinic of Tehran University of Medical science's Rehabilitation school
Full name of responsible person
Fatemeh zahra sadat mirian khoshkroudi
Street address
No. 336, Shemiran Corner, Safi Alishah Street, Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Fax
Email
rehabilitation@tums.ac.ir
Web page address
https://rehab.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh zahra sadat mirian khoshkroudi
Street address
No. 336, Shemiran Corner, Safi Alishah Street, Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
rehabilitation@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
Nourodin nakhostin ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 336, Shemiran Corner, Safi Alishah Street, Enghelab Street, Tehran, Faculty of Rehabilitation, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
nnansari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme zahra sadat mirian khoshkroudi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 336, Shemiran Corner, Safi Alishah Street, Enghelab Street, Tehran, Faculty of Rehabilitation, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
fatememirian70@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh zahra sadat mirian khoshkroudi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 336, Shemiran Corner, Safi Alishah Street, Enghelab Street, Tehran, Faculty of Rehabilitation, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
fatememirian79@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
All relevant data that has been agreed to be published can be shared.
When the data will become available and for how long
6 months after results
To whom data/document is available
It will be accessible to everyone involved in the industry.
Under which criteria data/document could be used
For researchers who are conducting research in this field and need information to improve their studies.
From where data/document is obtainable
1.Email
2.Contact Number
3.Postal Address
What processes are involved for a request to access data/document
The individual submits their request, and after the necessary checks are made regarding how the data will be used, the individual's job scope, and the necessary documents are provided to the individual.کل