The immediate Effect of Ankle Muscles Dry Needling on Brain 's Functions in healthy and ankle functional instability during functional task by Functional Magnetic Resonance Imaging.
Comparison and determination of the effect of dry needling on the human brain by functional magnetic resonance imaging in healthy individuals and patients with ankle instability.
Design
A randomized double blinded clinical trial with the parallel group design of 21 subjects.
Settings and conduct
Patients are selected from the volunteers referring to the rehabilitation clinics of Tehran University of Medical Sciences and healthy subjects are selected from the students of Tehran University of Medical Sciences by registering personal information and evaluating the outcome variables. Participants are not aware of the difference in treatment techniques and the examiner is not aware of the allocation groups of participants. The performer of the intervention has no information about the results of the evaluations.
Participants/Inclusion and exclusion criteria
Healthy and right ankle sprain participants (age: 18-40). No history of sports activities (Baecke questionnaire). Ankle sprain's subjects should have at least grade two of sprain based on the West Point classification; exclusion criteria: Any history of neurological and cardiovascular diseases. Musculoskeletal disorder in other lower limb joints in ankle sprain subjects and any musculoskeletal disorder in lower limbs of the healthy participants. Any Contraindications of MRI.
Intervention groups
In two groups the needles are used in fast in fast out cone shape technique for ankle muscles, including the tibialis anterior and the peroneus longus(This method will be applied both in healthy and ankle impairment subjects). Each needle is applied for one minute. The number of treatment session will be one session. In another group, sham needles are inserted to the target muscles and the same procedure will be applied.
Main outcome variables
Location of the activated brain area, dorsiflexor strength, dorsiflexor active range of motion, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210713051875N2
Registration date:2022-12-11, 1401/09/20
Registration timing:prospective
Last update:2022-12-11, 1401/09/20
Update count:2
Registration date
2022-12-11, 1401/09/20
Registrant information
Name
Roshanak Honarpisheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7751 0174
Email address
rhonarpisheh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-05-19, 1402/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The immediate Effect of Ankle Muscles Dry Needling on Brain 's Functions in healthy and ankle functional instability during functional task by Functional Magnetic Resonance Imaging.
Public title
The Effect of Dry Needling on Human's Brain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy and right ankle sprain participants (18-40 years old)
Subjects do not participate in any sports or physical activities, based on Baecke questionnaire (8 score or less)
Contraindications of dry needling
Subjects with right ankle sprain should have following conditions:1- at least 2 history of ankle sprains that has disturbed the daily activities of the person for at least one day and the symptoms of inflammation, swelling, pain and redness have been seen 2- Ankle sprain classification based on the West Point ankle sprain classification system is at least grade two 3- feeling of instability or sudden giving way of the ankle ,at least twice during the last 6 months
Right domain leg
Exclusion criteria:
Any history of neurological and cardiovascular diseases
musculoskeletal disorder in other lower limb joints in ankle sprain subjects and any musculoskeletal disorder in lower limbs of the healthy participants
Any ankles' deformity
Any medical conditions including headache , … during study
Drug abuse or any medical use
Contraindications of MRI including any metal object in the body, pace maker and …
Drink caffeine couple of hours before brain scan
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
21
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the number of healthy subjects in each group, the particular sort of intervention ( real or sham needle) is written on a piece of paper. Each paper is placed in a sealed envelope. One envelope will be chosen randomly by the therapist at the beginning of the study session and the patient's intervention will be selected based on that. If any of the subjects is omitted from the study, one envelope related to the excluded subject's group will be replaced and they will be mixed again. Subjects with ankle impairment will receive real needling.
Blinding (investigator's opinion)
Double blinded
Blinding description
At first, necessary explanation about the study and its aims will given to the participants. The explanation of the existence of two groups are given to the healthy subjects; Whereas no information about the difference interventions between two groups will be given to them. There will be no connection between subjects of each groups. This way they will be blind regarding intervention methods. In addition examination will be preformed by a physiotherapist who is not aware of the participant's group. So examiner is blind to the treatment method of each participant.
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 & Rehabilitation schools- Tehran university of Medical Sci
Street address
Quds Ave, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
2181455618
Approval date
2022-11-28, 1401/09/07
Ethics committee reference number
IR.TUMS.FNM.REC.1401.115
Health conditions studied
1
Description of health condition studied
Ankle functional instability
ICD-10 code
M25.371
ICD-10 code description
Other instability, right ankle
Primary outcomes
1
Description
Coordinates of maximum intensity; Voxel count; Peak intensity
Timepoint
During dorsiflexion movement (before dry needling intervention), during dry needling intervention, during dorsiflexion movement (after dry needling intervention)
Method of measurement
Functional magnetic resonance imaging machine
Secondary outcomes
1
Description
Dorsi flexor strength
Timepoint
Before intervention, immediately after intervention
Method of measurement
Manual dynamometer
2
Description
Active dorsi-flexor range of motion
Timepoint
Before intervention, immediately after intervention
Method of measurement
Standard goniometer
3
Description
Pain
Timepoint
Before intervention, immediately after intervention
Method of measurement
Persian version of McGill Pain Questionnaire Short-form
Intervention groups
1
Description
Intervention group: Dry needling is performed by fast in fast out technique for the tibialis anterior and peroneus longous muscles.
Category
Rehabilitation
2
Description
Control group: The sham dry needling procedure is performed for one minute on the location of tibialis anterior and peroneus longous muscles.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
School of rehabilitation, Tehran University of Medical Science
Full name of responsible person
Roshanak Honarpisheh
Street address
Department of physiotherapy, School of Rehabilitation, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 0174
Email
rhonarpisheh@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotohi
Street address
Vice Chancellor for Research and Technology, Central Organization of Tehran University of Medical Sciences, 6th Floor, Ghods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
vcr@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
Roshanak Honarpisheh
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department, School of Rehabilitation, Enghelab St
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
009877520174
Email
rhonarpisheh@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roshanak Honarpisheh
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department, School of Rehabilitation, Enghelab St
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
009877520174
Email
rhonarpisheh@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roshanak Honarpisheh
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
خیایان انقلاب، دانشکده توانبخشی، گروه فیزیوتراپی
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
0098217752014
Email
rhonarpisheh@razi.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
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 institution
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 St; 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 E-mail to the corresponding author: professor Soofia Naghdi (naghdi@sina.tums.ac.ir) and request the data. The researcher will be answered as soon as possible.