Protocol summary
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Study aim
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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.
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Design
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A randomized double blinded clinical trial with the parallel group design of 21 subjects.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Location of the activated brain area, dorsiflexor strength, dorsiflexor active range of motion, pain
General information
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Reason for update
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data acquisition time has been modified because of the technical adjustment of the fMRI in the Lab.
Other modification: reliable questionnaire of Cumberland Ankle Instability Tool will be also used as one of the inclusion criteria for participants with ankle instability.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210713051875N2
Registration date:
2022-12-11, 1401/09/20
Registration timing:
prospective
Last update:
2023-10-20, 1402/07/28
Update count:
2
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Registration date
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2022-12-11, 1401/09/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-11, 1402/08/20
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Expected recruitment end date
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2024-04-17, 1403/01/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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The Effect of Dry Needling on Human's Brain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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 instability will be diagnosed by a self-administered questionnaire of Cumberland Ankle Instability Tool 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
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Age
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From 18 years old to 40 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Outcome assessor
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Sample size
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Target sample size:
21
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-11-28, 1401/09/07
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Ethics committee reference number
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IR.TUMS.FNM.REC.1401.115
Health conditions studied
1
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Description of health condition studied
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Ankle functional instability
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ICD-10 code
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M25.371
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ICD-10 code description
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Other instability, right ankle
Primary outcomes
1
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Description
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Coordinates of maximum intensity; Voxel count; Peak intensity
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Timepoint
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During dorsiflexion movement (before dry needling intervention), during dry needling intervention, during dorsiflexion movement (after dry needling intervention)
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Method of measurement
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Functional magnetic resonance imaging machine
Secondary outcomes
1
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Description
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Dorsi flexor strength
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Timepoint
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Before intervention, immediately after intervention
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Method of measurement
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Manual dynamometer
2
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Description
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Active dorsi-flexor range of motion
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Timepoint
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Before intervention, immediately after intervention
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Method of measurement
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Standard goniometer
3
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Description
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Pain
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Timepoint
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Before intervention, immediately after intervention
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Method of measurement
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Persian version of McGill Pain Questionnaire Short-form
Intervention groups
1
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Description
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Intervention group: Dry needling is performed by fast in fast out technique for the tibialis anterior and peroneus longous muscles.
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Category
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Rehabilitation
2
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Description
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Control group: The sham dry needling procedure is performed for one minute on the location of tibialis anterior and peroneus longous muscles.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The raw data of research and its analysis will be available to the researcher if they request it.
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When the data will become available and for how long
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After the publication of articles resulting from the research.
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To whom data/document is available
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Researchers working in academic institution
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Under which criteria data/document could be used
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The data are only available to other researchers to study and evaluate treatment outcomes.
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From where data/document is obtainable
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Department of physiotherapy, School of Rehabilitation, Enghelab St; Professor Soofia Naghdi Email address: naghdi@sina.tums.ac.ir
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What processes are involved for a request to access data/document
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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.
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Comments
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