Protocol summary

Study aim
Comparing dry needling and myofascial release in improving pain, function, and ultrasonic changes of the hamstring muscle in soccer players with hamstring muscle trigger points.
Design
Clinical trial, with parallel groups, single-blind, randomized
Settings and conduct
Football players, after consenting to participate in the study, pain, functional ability of partnering, distance between finger and toe, functional reach, and hamstring muscle thickness will be measured. For blinding, the evaluator and the therapist are not the same. Finally, participants were block randomly divided into dry needling and myofascial release groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: males between the ages of 18 - 35, The professional football athletes with hamstring trigger points diagnosed by a physiotherapist using Travell-Simons criteria. Exclusion criteria : history of lower limb fracture or surgery within the past year, presence of any lower limb pathologies like vascular diseases or osteoarthritis, fear of needles, pain score (VAS) between 4-7, recent physiotherapy treatment for the lower limb in the last 6 months, diabetes, lower limb deformities, unwillingness to follow intervention protocol or outcome measures, receiving other treatments for pelvic pain trigger points in the past 4 weeks.
Intervention groups
Dry needling group: In this group, the Deep DN technique will be used with sterile needles on points at the end of the hamstring muscle. Sessions will occur twice a week for 10 minutes each. Myofascial release group: In this group, Myofascial release technique exercises will be performed for two weeks (4 sessions), with each session consisting of a 60-second massage on the hamstring from the distal to the proximal hamstring area.
Main outcome variables
pain, functional ability of hamstring, finger to floor distance Functional reach, Hamstring strength and thickness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180314039086N1
Registration date: 2024-11-14, 1403/08/24
Registration timing: prospective

Last update: 2024-11-14, 1403/08/24
Update count: 0
Registration date
2024-11-14, 1403/08/24
Registrant information
Name
Marzieh Mortezanejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3332 8502
Email address
mmortezanejad98@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-04-19, 1404/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of dry needling and myofascial release methods in improve pain, with hamstring trigger Football Playersin and ultrasonic changes of hamstring muscle functional ability points
Public title
dry needling and myofacial release on hamstring trigger point
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Professional athlete in the field of football Football players with hamstring trigger points whose trigger points have been diagnosed by a physiotherapist using Travell & Simons criteria. Age between 18 -35 years
Exclusion criteria:
A history of fracture and surgery in the lower limb in the last year Presence of any pathology in the lower limbs such as vascular diseases and osteoart hritis Fear of needles Having a pain score (VAS) in the range of 7-10 receiving physiotherapy treatment for the lower limb during the last 6 months Having diabetes Sensitivity to needles The presence of any type of lower limb deformity Athletes who cannot or do not want to comply with the intervention protocol or outcome measures Received any other treatments for joint trigger points or pelvic pain in the past 4 weeks, such as medicine, injection, acupuncture, or physiotherapy Football players who have other neurological or musculoskeletal conditions that may affect the hamstring muscle or hip area, such as lumbar disc herniation, sciatica, piriformis syndrome, or hip disease, and have received physiotherapy treatment for the lower limb in the last 6 months
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified Permuted Block Randomization will be utilized with 11 blocks of 4 individuals assigned to each group. Group A will receive hamstring needling, while Group B will receive hamstring myofascia release. The order of interventions A and B within blocks numbered 1 to 11 will be determined by the project's methodological consultant and provided to the project's executive supervisor, who will then assign each qualified participant.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator of the results is not the same as the subject who sampled.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of semnan university of medical sciences and health service
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2024-10-23, 1403/08/02
Ethics committee reference number
IR.SEMUMS.REC.1403

Health conditions studied

1

Description of health condition studied
Trigger points in the hamstring
ICD-10 code
M79.1
ICD-10 code description
Myalgia

Primary outcomes

1

Description
Hamstring functional assessment, Hamstring thickness ultrasonography
Timepoint
Before the treatment and immediately after the treatment
Method of measurement
single leg hamstring bridge test, finger floor distance, functional reach test, ultrasonigraphy

Secondary outcomes

1

Description
pain and strength assessment in hamstring
Timepoint
before and immediately after the treatment
Method of measurement
visual analog scale, dynamometer

Intervention groups

1

Description
Intervention group:En Dry needling group: In this group, the Deep DN technique will be used with sterile needles on points at the end of the hamstring muscle. Sessions will occur twice a week for 10 minutes each. the proximal hamstring area.
Category
Treatment - Devices

2

Description
Intervention group:Myofascial release group: In this group, Myofascial release technique exercises will be performed for two weeks (4 sessions), with each session consisting of a 60-second massage on the hamstring from the distal to proximal
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences and Health ser
Full name of responsible person
Ziaeddin Safavi Farrokhi
Street address
Tabatabaee clinic, ghods Blvd, mashahir square, semnan, iran
City
Semnan
Province
Semnan
Postal code
3519655169
Phone
+98 23 3332 8502
Email
ziasafavi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Abbasali Vafaee
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1021
Email
sem.ums.res@gmail.com
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
Mahmood Bagheri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tabatabaee clinic, Ghods Blvd, Mashahir Square, semnan, iran
City
Semnan
Province
Semnan
Postal code
3519655169
Phone
+98 23 3332 8502
Email
Bagheri.Mahmud00@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Sfavi Farrokhi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabatabaee clinic, Ghods Blvd, Mashahir Square, Semnan, IRAN semnan, iran
City
Semnan
Province
Semnan
Postal code
3519655169
Phone
0098233328502
Email
ziasafavi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
marzieh mortezanejad
Position
staff
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Tabatabaee clinic, ghods Blvd, mashahir square, semnan, iran
City
semnan
Province
Semnan
Postal code
3519655169
Phone
+98 23 3332 8502
Email
mmortezanejad98@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
there is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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