1- Determining the impact of spasticity of forearm pronator muscles on spasticity of other muscles and upper limb function in patients with chronic stroke.
2- If this method is effective, it is suggested to focus more on the treatment of pronators in improving spasticity and upper limb function.
Design
In this study, 20 patients are included in an easy and accessible way, and each patient will be considered as a control. In this cross-sectional study, all patients received sham needling in a three-session period, and then received dry needling in another three sessions with an interval of one week.
Settings and conduct
The intervention is carried out in the Faculty of Rehabilitation of Medical Sciences in Tehran.Each patient is considered as his own control.Patients receive dry needling or sham needling in separate sessions one week apart. Patients are not aware of the type of treatment.For each patient, the intervention will be carried out in two periods of three sessions
Participants/Inclusion and exclusion criteria
Age 40 to 75 years
The first stroke that resulted in hemiplegia
At least 6 months have passed since the stroke.
The spasticity score of the forearm pronator muscles on the MMAS scale is equal to 1 or more.
The supination range of the affected side should be at most 10% less than the healthy side.
No history of dry needling intervention
Not having cases of not using dry needling, such as fear of needles, receiving anticoagulants, infection, bleeding, or mental illness
No treatment with botox or nerve blockers in the last 6 months
Occurrence of any new lesion that affects muscle tone.
Dissatisfaction to continue cooperation
Taking any medicine that affects muscle tone
Intervention groups
Dry needling and Sham needling
Main outcome variables
severity of spasticity; active and passive range of motion; upper limb function; Function and Activities of daily living in the upper limb
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230721058873N1
Registration date:2023-09-22, 1402/06/31
Registration timing:registered_while_recruiting
Last update:2023-09-22, 1402/06/31
Update count:0
Registration date
2023-09-22, 1402/06/31
Registrant information
Name
Amirhossein Parsaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3320 1320
Email address
amirhosseinparsaei1377pt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2023-12-11, 1402/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study to investigate the effect of dry needling of forearm pronator muscles on spasticity and upper limb function in stroke patients
Public title
Investigating the effect of dry needling on spastic muscles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 to 75 years
The first stroke that resulted in hemiplegia
At least 6 months have passed since the stroke.
The spasticity score of the forearm pronator muscles on the MMAS scale is equal to 1 or more.
The supination range of the affected side should be at most 10% less than the healthy side.
No history of dry needling intervention
Not having cases of not using dry needling, such as fear of needles, receiving anticoagulants, infection, bleeding, or mental illness
No treatment with botox or nerve blockers in the last 6 months
Exclusion criteria:
Occurrence of any new lesion that affects muscle tone.
Dissatisfaction to continue cooperation
Taking any medicine that affects muscle tone
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Dry needling and sham needling are used in this study. that each patient will be considered as his own control. Patients receive sham needling in a three-session period and dry needling in another three-session period. But patients are blinded regarding the use of sham needles.
Placebo
Used
Assignment
Crossover
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
North Kargar St., in front of Farshi Moghadam St., Tehran University of Medical Sciences dormitory complex
City
Tehran
Province
Tehran
Postal code
1439957181
Approval date
2023-09-03, 1402/06/12
Ethics committee reference number
IR.TUMS.FNM.REC.1402.126
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G81.10
ICD-10 code description
Spastic hemiplegia affecting unspecified side
Primary outcomes
1
Description
spasticity degree
Timepoint
Before the first session and after the third session of Sham needling and dry needling and one week after the third session of dry needling
Method of measurement
With physical examination based on the MMAS scale
Secondary outcomes
1
Description
Active and Passive range of motion
Timepoint
Before the first session and after the third session of Sham needling and dry needling and one week after the third session of dry needling
Method of measurement
goniometry
2
Description
upper extremity function
Timepoint
Before the first session and after the third session of Sham needling and dry needling and one week after the third session of dry needling
Method of measurement
Physical examination based on Brunnstrom's recovery stage
3
Description
Function and daily life activities of daily living in the upper limb
Timepoint
Before the first session and after the third session of Sham needling and dry needling and one week after the third session of dry needling
Method of measurement
Physical examination and based on the CAHAI 13 scale
Intervention groups
1
Description
Intervention group: Dry needling,Dry needling with the Fast in/Fast out technique and in a conical shape for 1 minute is applied to the pronator teres and pronator quadratus muscles at the motor points of these muscles.
Category
Rehabilitation
2
Description
Control group: Sham needling,With the same dry needling protocol, the patient feels the sharpness of the needle on the skin without piercing the patient's skin.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Street address
Faculty of Rehabilitation, corner of Safi Alishah St., Pich Shamiran St., Tehran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Tehran University of Medical Sciences Headquarters,Qods Corner,Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 6696
Email
tumspr@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
Amirhossein Parsaei
Position
master of science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tehran University of Medical Sciences dormitory complex, in front of Farshi Moghadam St., North Kargar St.
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 11 3320 1320
Email
amirhosseinparsaei1377pt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhossein Parsaei
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
1439957181, Tehran University of Medical Sciences dormitory complex, in front of Farshi Moghadam St., North Kargar St.
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 11 3320 1320
Email
amirhosseinparsaei1377pt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhossein Parsaei
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
1439957181, Tehran University of Medical Sciences dormitory complex, in front of Farshi Moghadam St., North Kargar St.
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 11 3320 1320
Email
amirhosseinparsaei1377pt@gmail.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