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The effect of dry needling on elbow flexor spasticity and corticospinal excitability in patients with chronic stroke: A double-blind, randomized, controlled trial

Protocol summary

Study aim
evaluating the impact of dry needling on the corticospinal tract's excitability and spasticity in individuals with chronic stroke
Design
Clinical experiment on 30 patients, double-blinded, randomized, with a sham control group, Blocked-balance randomization was used for randomization
Settings and conduct
Patients are invited to Firouzgar Hospital for research, where they fill out informed consent forms. Baseline patient information such as age, sex, height, weight, duration, and side of affliction is recorded. Clinical assessments are performed, and patients are then divided into dry needling or sham needling treatment groups via block-balanced randomization. They receive their respective treatments over two more sessions, with follow-up evaluations after at least a week. Assessments include the MMAS spasticity scale, passive elbow resistance, active and passive elbow range of motion, and corticospinal tract excitability. The patient, healthcare provider, and evaluator are all blinded.
Participants/Inclusion and exclusion criteria
inclusion criteria: chronic stroke-related hemiplegia The MMAS scale indicates that the elbow flexor muscles on the afflicted side have spasticity that is at least 1 in severity. Age 30-75 Ability to follow instructions Criteria for not participating in the study: receiving alternative treatments Medication to reduce spasticity restricting TMS use
Intervention groups
The patient is placed in a supine position, head on the pillow, elbows flexed, and forearms supinated. Alcohol cleans the front arm skin. The dry needling group receives needles for the biceps brachialis and brachialis muscles for one minute using a sterile 0.3 x 0.5 needle and the Fast-in and Fast-out conical technique. The control group receives a placebo needle. Patients receive three sessions every other day.
Main outcome variables
Corticospinal tract excitability, Spasticity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230708058719N1
Registration date: 2023-08-02, 1402/05/11
Registration timing: prospective

Last update: 2023-08-02, 1402/05/11
Update count: 0
Registration date
2023-08-02, 1402/05/11
Registrant information
Name
Shiva Komesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7734 5462
Email address
sh-komesh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dry needling on elbow flexor spasticity and corticospinal excitability in patients with chronic stroke: A double-blind, randomized, controlled trial
Public title
Effect of Dry needling on decreasing elbow flexor stiffness in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
stroke-induced hemiplegia A minimum of six months have passed since the occurrence of the stroke, indicating a chronic stage of the disease. The degree of spasticity exhibited by the elbow flexor muscles on the affected side, as determined by the Modified Modified Ashworth Scale (MMAS), is a minimum of 1. Age 30-75 Ability to follow instructions
Exclusion criteria:
Individuals undergoing other treatments to alleviate spasticity The administration of pharmacological interventions aimed at reducing spasticity Not having any contraindications to using the TMS device, such as a history of seizures, epilepsy (the person themselves or a first-degree family member), a history of head injury or brain injury, metal in the head (outside the mouth) such as surgical clips, cochlear implants, or welded parts, a history of negative reactions to MRI or TMS, a history of brain-related diseases such as MS or brain tumors, a history of fainting, or a history of severe headaches,pregnancy or conception intention within the last three months, Past use of drugs known to reduce the seizure threshold, such as imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, theophylline, phenytidine, ketamine, gamma hydroxybutyrate, amphetamine, cocaine, and recent use of drugs or alcohol
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Block-Balanced Randomization:In this study, block balanced randomization is used to ensure that participants are allocated equally to each group. In order to maintain balance throughout the experiment, each block has an equal amount of each intervention, randomly assigned in unpredictable orders.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study used a double-blind randomized controlled trial design, wherein one proficient physiotherapist administers the treatments, while another physiotherapist conducts the assessments. Consequently, the evaluator lacks knowledge regarding the patient's group status, and the patients themselves remain unaware of their respective group assignments
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
School of Rehabilitation Sciences, Enghelab Ave., Tehran
City
tehran
Province
Tehran
Postal code
1148965111
Approval date
2023-06-19, 1402/03/29
Ethics committee reference number
IR.TUMS.FNM.REC.1402.063

Health conditions studied

1

Description of health condition studied
chronic stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified

Primary outcomes

1

Description
Corticospinal excitability
Timepoint
prior to the commencement of the intervention, after three sessions of the intervention, and one week subsequent to the intervention.
Method of measurement
The transcranial magnetic stimulation device is utilized to measure the resting motor threshold in elbow flexor muscles while simultaneously recording the corresponding motor-evoked potential via electromyography

2

Description
Spasticity of the elbow flexor muscles
Timepoint
prior to the commencement of the intervention, after three sessions of the intervention, and one week subsequent to the intervention
Method of measurement
Modified Modified Ashworth Scale

Secondary outcomes

1

Description
The active and passive range of motion of the elbow joint
Timepoint
prior to the commencement of the intervention, after three sessions of the intervention, and one week subsequent to the intervention
Method of measurement
The assessment will be conducted utilizing a goniometry

2

Description
Passive resistance force
Timepoint
prior to the commencement of the intervention, after three sessions of the intervention, and one week subsequent to the intervention
Method of measurement
the hand-held dynamometer

Intervention groups

1

Description
Intervention group: In order to execute the intervention, the patient assumes a supine position. The head is positioned upon the pillow, aligned with the midline. The arms are slightly abducted, with the elbows slightly flexed and the forearms in a supinated position. The anterior aspect of the arm is sterilized using alcohol. Subsequently, within the dry needling group a sterile needle measuring 0.3 x 0.5 is employed by the Fast-in and Fast-out conical technique to administer needling to the biceps brachialis and brachialis muscles for a duration of one minute. The biceps brachii and brachialis muscles are penetrated at a distance of 2 centimeters out of the point where the upper three-fourths and lower one-fourth of the line connecting the coracoid process to the medial epicondyle of the humerus intersect.
Category
Rehabilitation

2

Description
Control group: instead of dry needles, sham needles will be employed to target the same muscle groups as previously mentioned. Sham needles have a relatively wide edge that solely induces skin irritation without penetrating the dermal layer.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Bijan Forough
Street address
Firoozgar Hospital, Beh Afarin St., Karim Khan Zand Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 8214 1000
Email
forogh.b@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fatuhi
Street address
Keshavarz Blvd., corner of Qods St., Central Organization ofTehran University of Medical Sciences, 6th floor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
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
Noureddin Nakhostin Ansari
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran, District 12, Enghelab St، Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 3939
Email
nakhostin@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shiva Komesh
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Tehran, District 12, Enghelab St، Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 3939
Email
sh-komesh@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shiva Komesh
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Tehran, District 12, Enghelab St، Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 3939
Email
sh-komesh@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 and analysis of the research will be made available to researchers upon their request, should it be deemed necessary by the researchers
When the data will become available and for how long
Following the publication of the articles derived from the conducted research
To whom data/document is available
Scholars conducting research within academic establishments
Under which criteria data/document could be used
The data is exclusively accessible to fellow researchers for the purpose of studying and evaluating treatment outcomes
From where data/document is obtainable
by contacting the corresponding author through email
What processes are involved for a request to access data/document
Send an email to the responsible author and request the document
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