The study of immediate effects of dry needling on electromyographical, biomechanical and clinical measures in MS subjects with Hamstring muscles spasticity with one week follow-up
Objective: To explore the immediate effects of dry needling on electromyographical, biomechanical and clinical measures in MS subjects with Hamstring muscles spasticity in a controlled clinical trial
Research design: controlled clinical trial, randomized, blinded
Participants: MS subjects with Hamstring muscles spasticity
Main inclusion criteria:
• Taking interferon drugs
• No other neurological condition
• Walking ability with or without walking aids
• Lower extremity MMAS spasticity score≥1
• No contraindications for DN
Main exclusion criteria:
• MS attack during the study
• Taking antispastic drugs
Sample size: 24 for each group and 48 totally
Intervention: Dry Needling
Duration: 1 minute for each part of hamstring muscle
Primary outcome measure:
• spasticity of hamstring muscle
• hamstring muscle electrical activity
Secondary outcome measure:
• Biomechanical changes in hamstring muscle
• Patient's motor function
The assessor will be blinded to what group the patient has allocated to.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100736624N1
Registration date:2017-11-10, 1396/08/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-10, 1396/08/19
Registrant information
Name
maede khalifeloo
Name of organization / entity
tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 678 3476
Email address
m-khalifeloo@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Dean deputy of research
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of immediate effects of dry needling on electromyographical, biomechanical and clinical measures in MS subjects with Hamstring muscles spasticity with one week follow-up
Public title
Immediate effects of dry needling Hamstring muscles spasticity in in MS subjects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are:
• Being diagnosed with MS (RRMS)
• Taking interferon drugs
• No other neurological condition
• Walking ability with or without walking aids
• Being able to understand and follow the instructions
• EDSS>6-6.5
• Lower extremity MMAS spasticity score≥1
• Knee contracture≤10%
• No Botox injection since last 3 months
• No contraindications for DN
• No MS attack in previous month
• Not to participate in other treatment protocols
Exclusion criteria are:
• Unwilling to take part in the study
• MS attack during the study
• Taking antispastic drugs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Dry needling will apply by a therapist and another therapist who doesn’t know which group patient has allocated to, will do all assessments.
Randomization: Random table number
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tehran university of medical sciences
Street address
tehran university of medical sciences
City
tehran
Postal code
Approval date
2017-08-19, 1396/05/28
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3232
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Spasticity of hamstring muscle
Timepoint
Before, after, one week later as follow up
Method of measurement
MMAS
2
Description
Hamstring muscle electrical activity
Timepoint
Before, after, one week later as follow up
Method of measurement
sEMG
Secondary outcomes
1
Description
Biomechanical changes in hamstring muscle
Timepoint
Before, after, one week later as follow up
Method of measurement
Spasticiity evaluation by dynamometer
2
Description
Patient's motor function
Timepoint
Before, after, one week later as follow up
Method of measurement
By T25FW test
Intervention groups
1
Description
1 minute dry needling for each medial and lateral parts of hamstring muscle
Category
Treatment - Other
2
Description
Patients in control group won't receive intervention. they will rest in prone position for 2 minutes.