Protocol summary

Study aim
The study of the neurophysiologic effects of dry needling on quadriceps muscle fatigue of amateur healthy men athletes
Design
A parallel, randomized, double blinded, sham controlled clinical trial with 20 participants. Randomization is carried out with sealed envelops.
Settings and conduct
The study is done at the rehabilitation department of Tehran University. H-reflex of the quadriceps muscle (alpha-motorneuron excitability), single leg hop (function) and single leg stance (balance) are done by participants on their dominant lower extremity randomly. also the maximum isometric torque is measured by a handheld dynamometer and measuring the moment arm length. after that, squat protocol is used to induce quadriceps muscle fatigue. tests are repeated after fatigue. after that dry needle in the intervention group and sham needle in the placebo group are performed. tests are repeated after needling and also after a hour. to blinding, tests and measurements are done by the assessor, who is unaware of the groups of people, and intervention is done by another person.
Participants/Inclusion and exclusion criteria
Inclusion criteria include the age of 18-40, doing minimum exercise of 3 one-hour sessions per week, no lower extremity injury and no previous experience of dry needle, and exclusion criteria include people's inability or dissatisfaction to continue the study, contraindications for dry needle and doing strenuous activity during 48 hours before the study.
Intervention groups
While the subject was in supine with the leg in an extended neutral position, points on the VM, VL, and the RF muscles were randomly needled. People in the placebo group get into the same position, and they are needled at the same points as the intervention group. In this group needles are plastic ones in the tubes.
Main outcome variables
maximum isometric torque of quadriceps, balance, function, Hmax/Mmax ratio

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221201056676N1
Registration date: 2023-05-16, 1402/02/26
Registration timing: prospective

Last update: 2023-05-16, 1402/02/26
Update count: 0
Registration date
2023-05-16, 1402/02/26
Registrant information
Name
Melika Rostamkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6619 6145
Email address
melikarostamkhani137@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-23, 1402/03/02
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the neurophysiologic effects of dry needling on quadriceps muscle fatigue of amateur healthy men athletes immediately and one hour after dry needling
Public title
Study of the effects of dry needling on fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
no history of lower extremity injury no vestibular disorders no cardio-vascular-pulmunary diseases no neuromusculoskeletal diseases age of 18-40 years minimum exercise of 1-hour, 3 sessions per week (at least 2 months) no pain in lower extremity in at least recent 2 months no Trypanophobia (needle phobia) no needle contradictions no history of dry needle experience
Exclusion criteria:
lack of consent have pain during the study inability to continue the test have strenuous physical activity 48 hours before the test being a physical therapy student
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with sealed envelops: every participants are given a personal information form. there are written A and B on these forms to determine the intervention and placebo groups. these forms are given to participants randomly. if someone get the A form, he would be in the intervention group and if he get the B form, he would be in the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
to blinding, tests and measurements are done by the assessor, who is unaware of the groups of people. on the other hand intervention is done by another person. Also, for intervention, people in the placebo group are set on the same position as the intervention group and they get the sham needles (plastic needles on the tube) on the same points as the intervention group. these needles are put on the skin and are pushed on it, but they do not enter into body.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Nursing and Midwifery department and Rehabilitation department of Tehran Univers
Street address
No. 20, West First Golzar Ave., Majdi Blvd., Artesh Highway
City
Tehran
Province
Tehran
Postal code
1956973773
Approval date
2022-11-28, 1401/09/07
Ethics committee reference number
IR.TUMS.FNM.REC.1401.111

Health conditions studied

1

Description of health condition studied
fatigue
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
maximum isometric torque of quadriceps
Timepoint
measuring maximum isometric torque of quadriceps at the beginning of the study, after fatigue protocol, after intervention, and one hour after intervention
Method of measurement
handheld dynamometer

2

Description
function
Timepoint
measuring function at the beginning of the study, after fatigue protocol, after intervention, and one hour after intervention
Method of measurement
single leg hop test

3

Description
H/M ratio
Timepoint
measuring H/M ratio at the beginning of the study, after fatigue protocol, after intervention, and one hour after intervention
Method of measurement
electromyography (EMG)

Secondary outcomes

1

Description
balance
Timepoint
measuring balance at the beginning of the study, after fatigue protocol, after intervention, and one hour after intervention
Method of measurement
single leg stance test

Intervention groups

1

Description
Intervention group: An expert physical therapist qualified in DN performs the needling procedure of the Quadriceps Femoris of the dominant lower extremity. While the subject is in supine with the leg in an extended neutral position, points on the Vastus Medialis (VM), Vastus Lateralis (VL), and the Rectus Femoris (RF) muscles are randomly needled using stainless steel needles with a diameter of 0.3 mm and a length of 50 mm each for one minute using a fast in-fast out technique. The VM point is located at about 25% of the distance of a line from the medial superior border of the patella to the Anterior Superior Iliac Spine (ASIS); the VL point is located at the mid-thigh along a line from the lateral superior border of the patella to the apex of greater trochanter; the RF point is located at the mid-thigh along a line from the superior border of patella to the ASIS
Category
Rehabilitation

2

Description
Control group: Cases in this group are positioned as same as the intervention group. Sham needles, plastic needles in tubes, are applied to the same points. These needles are put on the skin and are pushed, but they do not insert into it.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Rehabilitation of Tehran University of Medical Sciences
Full name of responsible person
Melika Rostamkhani
Street address
Pich-e-Shemiran, Enghelab street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7764 4937
Email
rehabilitation@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
No. 5, Hoseini Alley, 21Metrijey Street, Ostadmoein Square
City
Tehran
Province
Tehran
Postal code
1341767177
Phone
+98 21 6619 6145
Email
melikarostamkhani137@yahoo.com
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
Melika Rostamkhani
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 5, Hoseini Alley, 21Metrijey Street, Ostadmoein Square, Azadi Street
City
Tehran
Province
Tehran
Postal code
1341767177
Phone
+98 21 6619 6145
Email
melikarostamkhani137@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Melika Rostamkhani
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.5, Hoseini Street, 21Metrijey Street, Ostadmoein Square, Azadi Street
City
Tehran
Province
Tehran
Postal code
1341767177
Phone
+98 21 6619 6145
Email
melikarostamkhani137@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Melika Rostamkhani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.5, Hoseini Street, 21Metrijey Street, Ostadmoein Square, Azadi Street
City
Tehran
Province
Tehran
Postal code
1341767177
Phone
+98 21 6619 6145
Email
melikarostamkhani137@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
The raw data of research and its analysis will be available to the researcher if they request it.
When the data will become available and for how long
After the publication of articles resulting from the research.
To whom data/document is available
Researchers working in academic institutions.
Under which criteria data/document could be used
The data are only available to other researchers to study and evaluate treatment outcomes.
From where data/document is obtainable
Department of physiotherapy, School of Rehabilitation, Enghelab street; Professor Soofia Naghdi Email address: naghdi@sina.tums.ac.ir
What processes are involved for a request to access data/document
By sending an official Email to the corresponding author: professor Soofia Naghdi (naghdi@sina.tums.ac.ir) and requesting the data, the researcher will be answered as soon as possible.
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