Investigating the Effect of Dry Needling of Tibialis anterior, Peroneus Longus and Brevis Muscles on Proprioception, Ankle Muscle Strength and Balance in Young Amateur Athletes with Chronic Ankle Instability
Investigating the effect of dry needling of tibialis anterior, peroneus longus and brevis muscles on proprioception, ankle muscle strength and balance in young non-professional athletes with chronic ankle instability.
Design
The upcoming study is conducted as a double-blind randomized controlled clinical trial (RCT) in such a way that the evaluator and the patients are blinded.
Settings and conduct
The upcoming study is conducted as a double-blind randomized controlled clinical trial (RCT) in such a way that the evaluator and patients are blinded.
The study is carried out in Baqiyat Allah Hospital.
Participants/Inclusion and exclusion criteria
Their age should be between 18 and 40 years.
Doing three sessions of at least one hour of exercise per week.
Have a history of sprained ankle.
A history of at least one severe ankle sprain.
primary torsion; occurred at least 12 months before the start of the study.
The last injury occurred more than three months before the start of the study.
Not having cases of non-use of dry needles.
Intervention groups
And the treatment in the control group (sham needle) and in the intervention group (dry needle) is performed for three sessions and one day in between.
Main outcome variables
Maximum muscle isometric strength
the balance
proprioception
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230918059459N1
Registration date:2023-12-11, 1402/09/20
Registration timing:retrospective
Last update:2023-12-11, 1402/09/20
Update count:0
Registration date
2023-12-11, 1402/09/20
Registrant information
Name
Maryam Asgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3337 7812
Email address
maryamasgari376@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Dry Needling of Tibialis anterior, Peroneus Longus and Brevis Muscles on Proprioception, Ankle Muscle Strength and Balance in Young Amateur Athletes with Chronic Ankle Instability
Public title
Investigating the Effect of Dry Needling in Chronic Ankle Instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have a History of Sprained Ankle.
Have a History of at Least One Severe Ankle Sprain.
Primary Torsion; Occurred at Least 12 Months Before the Start of the Study.
Be Accompanied by Inflammatory Symptoms.
At Least One Day of Physical Activity has Disturbed the Person.
The Last Injury Occurred More than Three Months Before the Start of the Study.
A History of Previous Ankle Injury in the form of Ankle Sprains or Sprains Repeats or Feels Unstable.
Their Age Should be Between 18 and 40 Years.
Do Three Sessions of at Least One Hour of Exercise Per Week.
Do Not be Afraid of Needles.
Do Not Have Trypanophobia.
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
People are Randomly Divided in to Two Groups using the Randomization Sequence.
It will be done through Randomization.com and using Block Balanced Randomization Method; And for the Purpose of Cocleament Allocation, Sealed and Numbered Envelopes are Used, which are Provided to the Participants.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Upcoming Study is Conducted as a Double-Blind Randomized Controlled Clinical Trial (RCT) in Such a Way that the Evaluator and the Patients are Blind.
Placebo
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
Rehabilitation of Medical Sciences Tehran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2023-09-13, 1402/06/22
Ethics committee reference number
IR.TUMS.FNM.REC.1402.130
Health conditions studied
1
Description of health condition studied
Chronic Ankle Instability
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Muscle Strength
Timepoint
At the Beginning of the Study (Before the Start of the Intervention) and at the End of the Study (After the Intervention Sessions)
Method of measurement
A Dynamometer is Used to Measure Strength.
2
Description
Proprioception
Timepoint
At the Beginning of the Study (Before the Start of the Intervention) and at the End of the Study (After the Intervention Sessions).
Method of measurement
Joint Angle Reconstruction Error is Used to Measure Proprioception.
3
Description
Balance
Timepoint
At the Beginning of the Study (Before the Start of the Intervention) and at the End of the Study (After the Intervention Sessions).
Method of measurement
a One-Leg Standing Test is Used to Measure Balance.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for the intervention group, dry needling treatment is used in the tibialis anterior and peroneal muscles for three sessions.
Category
Rehabilitation
2
Description
Control group: For the control group, sham needles are used for three sessions in the muscles of the tibialis anterior and peroneal muscles.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatullah Hospital
Full name of responsible person
Maryam Asgari
Street address
Mulla Sadra
City
Tehran
Province
Tehran
Postal code
141556437
Phone
+98 21 8126 5352
Email
bag@bmsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Bahare Yazdizadeh
Street address
Keshavarz Blvd., Corner of Qods St., Headquarters of Tehran University of Medical Sciences, 6th Floor, Room 605, Research and Technology Affairs Management Unit
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
reaserch@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
Maryam Asgari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, corner of Safi Alishah St., Pich Shamiran St., Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Fax
Email
maryamasgari376@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zeenat Ashnagar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, corner of Safi Alishah St., Pich Shamiran St., Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Asgari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, corner of Safi Alishah St., Pich Shamiran St., Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
maryamasgari376@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
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