The aim of this study is to evaluate the effect of dry needling on quadriceps muscle fatigue in taekwondo athletes.
Design
A controlled clinical trial with parallel groups, triple-blind, randomized, involving 80 athletes. Opaque envelopes will be used for randomization.
Settings and conduct
Medical clinics specializing in taekwondo athletes; Study Population: Taekwondo practitioners; Blinding Type: Patients, Evaluator, Statistical Analyst.
Participants/Inclusion and exclusion criteria
Athletes between the ages of 18-40 will voluntarily and knowingly participate in the study. The exclusion criteria include the following:
Any injury, fracture, or pain in the lower extremities during the intervention
Any cardiovascular, neuromuscular, or balance-related disease
Intense physical activity within 48 hours before the intervention
History of dry needling on the quadriceps muscles within the last three months
Prohibition from receiving dry needling for any reason
Inability to perform tests and exercises to induce fatigue
Lack of consent
Intervention groups
Intervention group: Receiving dry needling on the quadriceps muscle after inducing fatigue
Control group: Receiving sham needling on the quadriceps muscle after inducing fatigue
Main outcome variables
IPT (Isometric Peak Torque)
SLHT(Single Leg Hop Test) for lower limb function
VJT(Vertical Jump Test) for lower limb strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210811052141N1
Registration date:2024-05-11, 1403/02/22
Registration timing:prospective
Last update:2024-05-11, 1403/02/22
Update count:0
Registration date
2024-05-11, 1403/02/22
Registrant information
Name
Amin Nakhostin-Ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7797 1942
Email address
a-nansari@alumnus.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of Dry Needling on Quadriceps Muscles Fatigue in Taekwondo Players
Public title
Effects of Dry Needling on Muscles Fatigue in Taekwondo Players
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Taekwondo players
Age between 18 and 40 years
Giving consent to participate
Exclusion criteria:
Any injury, fracture, or pain in the lower limbs at the time of the intervention
Having any cardiovascular, neuromuscular, or balance-related disease
Performing intense physical activity within 48 hours before the intervention
Previous history of dry needling on the quadriceps muscles in the past three months
Contraindications to dry needling for any reason x
Contraindications to dry needling for any reason Inability to perform the test and exercise to induce fatigue
Lack of consent
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to one of the two groups: Dry Needling or Placebo, and will not be informed which treatment they will receive. For this purpose, the allocated intervention will be written equally on slips of paper (40 slips for the main treatment with dry needling and 40 slips for the placebo treatment with sham needles), and these slips will be placed in opaque envelopes. Each patient will receive one envelope randomly assigned by the researcher.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The researcher and the study subject will be unaware of the assigned treatment, and evaluations will also be conducted by a physiotherapist who is blind to the allocated treatment. Furthermore, the analyses will be performed by an analyst who is unaware of the treatments.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Neuroscience Institute
Street address
Neuroscience Institute, Imam Khomeini Hospital Complex, Gharib street
City
Tehran
Province
Tehran
Postal code
Approval date
2021-06-01, 1400/03/11
Ethics committee reference number
IR.TUMS.NI.REC.1400.029
Health conditions studied
1
Description of health condition studied
Muscle fatigue in taekwondo players
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Muscle force
Timepoint
Before exercise, after exercise, after intervention
Method of measurement
IPT (Isometric Peak Torque)
Secondary outcomes
1
Description
Lower limb function
Timepoint
Before exercise, after exercise, after intervention.
Method of measurement
SLHT(Single Leg Hop Test)
2
Description
Lower limb strength
Timepoint
Before exercise, after exercise, after intervention.
Method of measurement
VJT(Vertical Jump Test)
Intervention groups
1
Description
Intervention group: Dry needling will be applied on the quadriceps muscle after exercise
Category
Rehabilitation
2
Description
Control group: Sham needle will be applied on the quadriceps muscle after exercise
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Street address
School of Rehabilitation; Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Neuroscience Institute, Imam Khomeini Hospital Compelx, Gharib street
City
Tehran
Province
Tehran
Postal code
Phone
+98 21 6658 1701
Email
tini@tums.ac.ir
Grant name
Grant code / Reference number
51539
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
Noureddin Nakhostin Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
nakhostin@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
nakhostin@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
nakhostin@tums.ac.ir
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All data will become available upon deidentification.
When the data will become available and for how long
The data will be available upon the completion of the study.
To whom data/document is available
Other Researchers
Under which criteria data/document could be used
Data may be used for research purposes.
From where data/document is obtainable
Applicants should email prof. Nakhostin Ansari at nakhostin@tums.ac.ir
What processes are involved for a request to access data/document
The data will be will be available from the corresponding author upon reasonable request.