Effect of dry needling technique on clinical, sonographic and biomechanical parameters of spastic upper extremity muscles in patients with chronic ischemic stroke
Effect of dry needling technique on clinical, sonographic and biomechanical parameters of spastic upper extremity muscles in patients with chronic ischemic stroke
Design
This clinical trial has a sham control group, with parallel groups, double-blinded, and randomized by stratified permutation blocks method with block size 4. Statistical software is used for randomization.
Settings and conduct
Patients referred to medical centers of SUMS who suffer from chronic ischemic stroke with spastic muscles in their upper limbs, enter the study according to the inclusion and exclusion criteria. Then they will sign the informed consent. After that they are randomly assigned to intervention group (routine physiotherapy with dry needling) and control group (routine physiotherapy with sham dry needling). Treatment by a physiotherapist, assessments by another physiotherapist and statistical analysis by a statistician will be performed who are unaware of group assignment.
Participants/Inclusion and exclusion criteria
Patients with chronic ischemic stroke in the age range of 35-65 years are included in the study. At least six months and maximum 2 years must be passed since the onset of their stroke. They cannot participate in this study if they are receiving other treatments.
Intervention groups
The intervention group receives dry needling treatment with routine physiotherapy and the control group receives routine physiotherapy with sham dry needling.
Main outcome variables
Resistance to passive stretching (spasticity) in the wrist and fingers flexor muscles; Upper limb motor function; Upper limb skill; Thickness of the FCU, FCR and FDP.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200904048609N1
Registration date:2020-09-23, 1399/07/02
Registration timing:prospective
Last update:2020-09-23, 1399/07/02
Update count:0
Registration date
2020-09-23, 1399/07/02
Registrant information
Name
Fatemeh Panahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
f_panahi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-14, 1399/08/24
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dry needling technique on clinical, sonographic and biomechanical parameters of spastic upper extremity muscles in patients with chronic ischemic stroke
Public title
Effect of dry needling technique on spastic upper extremity muscles in patients with chronic ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 35-65 years old
Stroke occurrence for first time
History of stroke onset at least 6 months and maximum of 2 years prior to the study
Spasticity existence in the wrist and fingers flexor muscles ( +1 to 3 based on the modified Ashworth scale)
Not taking any antispasmodics during the study for at least one month before the study beginning
Having minimal grip ability
Ability to understand and follow commands
Absence of cognitive impairment (Mini-Mental State Examination score >24)
Exclusion criteria:
Recurrent stroke
Having other neurological diseases
Cervical radiculopathy
Fixed contracture in wrist and finger muscles
Treatment with other therapies during this study
History of physiotherapy treatments in less than a month prior to study
History of treatment with dry needling technique after a stroke
Previous treatment with nerve blocks or neurolytic agents injection in motor point or Infiltration of botulinum toxin At any time after stroke
Uncontrolled hypertension
Uncontrolled diabetes
Upper limb fracture
Any absolute contraindication for using of deep dry needling (such as pregnancy, infection, coagulation defect, seizures or mental disorders, and fear of needles)
Reluctance to continue participating in the study
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two equal groups by using of stratified permutation blocks method, with a block size of 4 by using of random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The treatment will be performed by a physiotherapist and all variables will be measured by another physiotherapist who is unaware of the allocated groups, and the data will be analyzed by a statistician who is unaware of the group assignments.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shiraz University of Medical Sciences
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Approval date
2020-08-19, 1399/05/29
Ethics committee reference number
IR.SUMS.REHAB.REC.1399.028
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Spasticity
Timepoint
Before treatment, after the last treatment session, 1 month after the last treatment sessions
Method of measurement
Modified Ashworth scale
2
Description
Muscle thickness of FCU, FCR and FDP; Separately for each muscle, and generally for flexor group.
Timepoint
Before treatment, after the last treatment session, 1 month after the last treatment sessions
Method of measurement
Sonography
Secondary outcomes
1
Description
Flexor muscles compressibility
Timepoint
Before treatment, after the last treatment session, 1 month after the last treatment sessions
Method of measurement
Sonography
2
Description
Wrist reflex torque
Timepoint
Before treatment, after the last treatment session, 1 month after the last treatment sessions
Method of measurement
Isokinetic machine
3
Description
Wrist peak torque
Timepoint
Before treatment, after the last treatment session, 1 month after the last treatment sessions
Method of measurement
Isokinetic machine
4
Description
Upper limb motor function
Timepoint
Before treatment, after the last treatment session, 1 month after the last treatment sessions
Method of measurement
Fugl-Meyer scale
5
Description
Upper limb skill
Timepoint
Before treatment, after the last treatment session, 1 month after the last treatment sessions
Method of measurement
Box and block test
Intervention groups
1
Description
Intervention group: The intervention consists of 12 sessions (4 weeks, 3 sessions per week) routine physiotherapy treatment for stroke patients, including FES and exercise therapy for at least 40 minutes; And 4 sessions of dry needling treatment on FCU and FCR and FDP muscles once a week.
Category
Rehabilitation
2
Description
Control group: The intervention consists of 12 sessions (4 weeks, 3 sessions per week) routine physiotherapy treatment for stroke patients, including FES and exercise therapy for at least 40 minutes; And 4 sessions of sham dry needling treatment on FCU and FCR and FDP muscles once a week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers affiliated to Shiraz University of Medical Sciences
Full name of responsible person
Dr. Zahra Rojhani Shirazi
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
Email
rojhaniz@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Rezaianzadeh
Street address
Vice Chancellor for Research and Technology, Zand St. Shiraz, Fars The central building of Shiraz University of Medical Sciences, seventh floor,
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3235 7282
Email
rezaiana@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Panahi
Position
PhD candidate in physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
fatemeh.panahi85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Panahi
Position
PhD candidate in physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
fatemeh.panahi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Panahi
Position
PhD candidate in physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
fatemeh.panahi@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
After coordination with the Research Ethics Committee for approval of the ethics committee, participants data file will be provided In complete secrecy and for research purposes only.
When the data will become available and for how long
6 month after acceptance of the article by the journal.
To whom data/document is available
In addition to the principal researcher and the supervisor of the project, upon request, access to information can be reviewed by the Ethics Committee.
Under which criteria data/document could be used
Preferably it is only used for the subject of my research, but if research is to be done in order to use the statistical population, the main project executor and the student's main collaborator will make a decision with the permission of the ethics committee.
From where data/document is obtainable
Executors of the project can first be referred to through Dr. Zahra Rojhani Shirazi (09171127108), and the main colleague and student collaborator Ms Fatemeh Panahi (09183571646).
What processes are involved for a request to access data/document
6 months after the article was published, referring the request to the executor of the project, in addition, an official letter from the ethics committee will be commented on in order to obtain a license, and if the ethics committee approves, emphasizing the confidentiality of the information, the requested information will be provided to the applicant.