Comparative Effects of Dry Needling of Gastrocnemius -Soleus muscles on Neuromodulation, Spasticity, and Balance in patients with MS (relapsing-remitting) and stroke
Comparison of the effects of dry needling of gastrocnemius and soleus muscles on nerve modulation, spasticity, and balance in patients with MS (relapsing-recovering type) and stroke
Design
The prospective clinical trial, parallel-group trial, non-randomized
Settings and conduct
People referred to physiotherapy clinics are invited to participate in this study if they wish. After checking the inclusion and exclusion criteria and completing the written consent form to participate in the research, the patients will enter the study. The treatment procedure and evaluation of people will be done in the physical medicine and rehabilitation clinic of Firouzgar Hospital and the National Brain Mapping Laboratory. After completing the questionnaire containing demographic information, people are subjected to initial evaluation, which includes: functional balance tests (Timed up and go test and Four square steps) and checks neuromodulation with TMS-EMG parameters, and assessment of the intensity of spasticity with the Modified Modified Ashworth scale, also the active and passive range of motion of dorsiflexion of the ankle. After three weeks of intervention (one session of dry needling of the plantar flexor muscles each week, including the internal and external heads of gastrocnemius muscles and the soleus muscle), the subjects are re-evaluated and all the tests are re-evaluated will be In order to check the durability of the effects and follow up two weeks after the end of the intervention, re-evaluations will be done.
Participants/Inclusion and exclusion criteria
People with Remitting and Relapsing MS and stroke
Intervention groups
After the first evaluations, all subjects will receive dry needling for the gastrocnemius (medial and lateral head) and soleus muscles using a 0.30 x 50 mm filiform needle for one minute for each muscle.
Main outcome variables
Neuromodulation- Spasticity-Balance
General information
Reason for update
Acronym
Dry needling به اختصار می شود DN ,و Multiple sclerosis به اختصار می شود MS
IRCT registration information
IRCT registration number:IRCT20230206057343N1
Registration date:2023-02-09, 1401/11/20
Registration timing:prospective
Last update:2023-02-09, 1401/11/20
Update count:0
Registration date
2023-02-09, 1401/11/20
Registrant information
Name
Haniyeh Choobsaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 389 8910
Email address
choobsaz-h@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-08-01, 1402/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effects of Dry Needling of Gastrocnemius -Soleus muscles on Neuromodulation, Spasticity, and Balance in patients with MS (relapsing-remitting) and stroke
Public title
Comparing the effects of dry needling of ankle plantar flexor muscles on neuromodulation, spasticity, and balance in people with MS and stroke.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Remitting and relapsing Multiple sclerosis disease
Having a stroke
EDSS score less than 4 in the group of MS patients
Follow instructions
Spasticity of plantarflexors is equal to or greater than 1 using (MMAS scale)
No diabetes
Absence of any history of treatment with nerve blockers, or treatment with botulinum toxin A 6 months before entering the study.
No history of attacks in MS patients in the last 8 weeks
Absence of limitation of passive range of motion of more than 10 percent in ankle dorsiflexion compared to the less involved leg (absence of contracture).
Absence of other neurological disorder
Exclusion criteria:
Fear of dry needling
Recurrent stroke during the patient evaluation and intervention program
Occurrence of a new attack in a patient with MS
Contraindications to the use of TMS
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The study is a prospective clinical trial, where the subjects are in two different disease groups (multiple sclerosis and stroke), which are non-randomly placed in two groups, and the subjects receive the same intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Research in Nursing and Midwifery Faculty and Faculty of Rehabilitation, Tehran
Street address
Tehran, District 12, Enghelab St، Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
1148956111
Approval date
2023-02-06, 1401/11/17
Ethics committee reference number
IR.TUMS.FNM.REC.1401.167
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis (Remitting Relapsing)
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
2
Description of health condition studied
Stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Neuromodulation
Timepoint
Before the intervention, After 3 sessions of intervention, and 2 weeks after for follow up
Method of measurement
With Trans-cranial magnetic stimulation parameters, Including motor evoked potential (MEP) amplitude at rest and muscle motor threshold at rest (RMT) and motor evoked potential amplitude ratio in intracortical inhibition protocol (SICI) and motor evoked potential amplitude ratio in intracortical facilitation protocol (ICF).
2
Description
Spasticity
Timepoint
Before the intervention, after 3 sessions of intervention sessions, and two weeks after the last intervention session for follow-up
Method of measurement
Modified Modified Ashworth Scale
Secondary outcomes
1
Description
Functional Balance
Timepoint
Before the intervention, after 3 sessions of intervention sessions, and two weeks after the last intervention session for follow-up
Method of measurement
Timed up and go test and Four Square Step test
2
Description
Active and Passive ankle dorsiflexion ROM
Timepoint
Before the intervention, after 3 sessions of intervention sessions, and two weeks after the last intervention session for follow-up
Method of measurement
The evaluation will be done using a goniometry
Intervention groups
1
Description
Intervention group: Dry needling will be done on the internal and external head of the gastrocnemius muscle, and the soleus muscle (in the area of the motor point) by using a 0.30 x 50 mm foliform needle for one minute. For each muscle, dry needling by the fast in fast out method and in a cone shape will be done. Dry needling will be done for three weeks and one session every week.