Effects of kinesiotape on pain, range of motion, and functional status in patients with relapsing remitting Multiple Sclerosis: a randomized clinical trial
Determining the effect of kinesiotype on lower limb spasticity in patients with relapsing remitting multiple sclerosis.
Design
A single blinded randomized trial with 2 crossover groups
Settings and conduct
The study was conducted in Sinai Hospital on patients with a definitive diagnosis of relapsing remitting MS, and the number of samples for each group was 6 people and a total of 12 people. After obtaining consent to participate, people are divided into two groups using simple randomization. In the intervention group, KT is performed according to the method proposed by the International Kinesiotaping Association using a restraining method. closes on gastrosoleus muscles and hamstrings. Kinesiotape remains for 48 hours and then it is opened. Sham Taping ( without stretching and appropriate technique) is performed in the control group.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 50 with relapsing remitting MS with mild to moderate severity (EDSS less than 4.5) who complain of lower limb spasms and have the ability to walk at least 500 meters without assistance. Consent to participate in the study and not having a history of MS attack in the last month, and not having other musculoskeletal diseases or contraindications for taping.
Intervention groups
In group A (intervention), KT is closed according to the method proposed by the International Kinesiotaping Association (kinesiotaping.com) in a restrained way (from insertion to origin) on the gastrosoleus muscles and hamstrings. Kinesiotype remains for 48 hours and then it is opened.
In group B (control), Sham Taping (kinesiotype without stretching and appropriate technique) is performed.
Main outcome variables
Muscle spasticity and muscle function
General information
Reason for update
Acronym
KTMS
IRCT registration information
IRCT registration number:IRCT20240316061307N1
Registration date:2024-04-20, 1403/02/01
Registration timing:retrospective
Last update:2024-04-20, 1403/02/01
Update count:0
Registration date
2024-04-20, 1403/02/01
Registrant information
Name
Maryam Najafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3336 3554
Email address
m_najafi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of kinesiotape on pain, range of motion, and functional status in patients with relapsing remitting Multiple Sclerosis: a randomized clinical trial
Public title
kinesiotape in patients with Multiple myelosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of relapsing remitting MS with mild to moderate severity (EDSS less than 4.5)
Ability to walk at least 500 meters without using aids
Complaints of lower limb spasms
Exclusion criteria:
Taking muscle relaxants such as tizanidine, baclofen, methocarbamol
Not agreeing to participate or continue the participation
Participating in a rehabilitation program or sports activity in the past month
Presence of another musculoskeletal disease that affects the patient's lower limbs
Presence of kinesiotape contraindications such as: deep vein thrombosis, kidney failure, congestive heart disease, infection, wound, cancer and sensitivity to kinesiotape.
History of MS attack in the past month
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
12
More than 1 sample in each individual
Number of samples in each individual:
2
each patient has two lower limbs.
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining consent to participate in this research, each patient will be assigned a two-digit number from 01 to 24, according to the sequence of entering the study, and the statistician will select the first 12 cases using a table of random numbers and assign them intervention group and the rest of the people will be placed in the control group, and the created sequence will be placed inside sealed envelopes of the same shape, with the patients' code written on the outside, and the inside cannot be seen from the outside. Statistician do not know the identity of the patients and the subject of the study. In this way, on the day of the patient's presence to perform the intervention, the envelope related to that patient will be opened and the intervention will be performed on the patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the patients to the type of intervention performed for themselves or other participants in the study, taping will be done for all patients, and stretching training and spasticity and function evaluation will be done for all patients. And the only difference between the two groups will be the tipping technique. The statistician who will be in charge of analyzing the results will also be unaware of the intervention.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Sina Hospital
Street address
Imam Khomeini Ave.
City
تهران
Province
Tehran
Postal code
1136746911
Approval date
2023-05-24, 1402/03/03
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1402.029
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
In this study, the primary outcome is muscle spasticity,
Timepoint
In both groups, the following evaluations are performed before the intervention, immediately after the intervention and after opening the bandage (48 hours after the intervention).
Method of measurement
It is measured by the Modified Ashworth Scale (MAS). MAS is a scale for measuring muscle tone and is completed by the therapist who passively stretches the desired muscle group and scores the movement resistance between 0 and 5. which is rated as follows: 0: no increase in muscle tone; 1: A slight increase in muscle tone so that it appears with a slight cramp and release or a small resistance at the end of ROM. 1+: slight increase in muscle tone so that it appears with slight cramping or little resistance at the beginning or half of the ROM. 2: Significant increase in muscle tone in the majority of ROM so that the involved limb can be easily moved; 3: significant increase in muscle tone, but passive movement of the involved limb is difficult; and 4: the affected organ is rigid. This questionnaire was translated into Farsi in 2012 by Ansari et al. and its validity and reliability were evaluated. Another scale called Numeric Rating of Spasm or NRS is used to evaluate muscle spasm. To use this scale, the patient is asked to score his perception of spasm from 0 to 10.
2
Description
In this study, the primary outcome is the patient's muscle function.
Timepoint
In both groups, the following evaluations are performed before the intervention, immediately after the intervention and after opening the bandage (48 hours after the intervention).
Method of measurement
Timed up and go test (TUG) is used to evaluate patients' performance. In the Timed up and go test (TUG), the patient sits on a chair, when the test starts, the patient must get up from the chair, walk a distance of 3 meters and return to the chair and sit again. The test time is recorded in seconds. Another tool that is used to evaluate the performance of patients is the Multiple Sclerosis Walking Scale-12 questionnaire. It is one of the appropriate criteria that is usually used to evaluate the ability to walk in MS. is the MSWS-12. The MSWS-12 is a multi-item rating scale that assesses patients' perceptions of the impact of disease on their ability to walk. The MSWS-12 is a reliable, valid measure. and a patient-based questionnaire has been reported for walking ability in patients with MS. Using MSWS-12, patients are asked to rate the impact of MS on the ability to walk, run, climb stairs, and balance. in standing or walking and assessing the amount of support they needed while walking in the past two weeks. Aspects of walking such as distance, effort required while walking, smoothness of gait and concentration required while walking were also included. has been Limitation in walking is graded from 1 (not at all) to 5 (extremely) and the total score is calculated from 0 to 80, with high scores indicating more impairment in walking. Colleagues was prepared in 2015 and its validity and reliability have been evaluated.
Secondary outcomes
empty
Intervention groups
1
Description
In the KT intervention group, according to the method proposed by the International Association of Kinesiotaping (kinesiotaping.com), it is closed using a restraining method (from insertion to origin) on the gastrosoleus and hamstring muscles. For gastrosoleus muscle taping, the participant lies on the bed with his palm on the bed, the tip is cut in a Y shape and a part of the beginning of the tip (its base) is attached to the sole of the foot without any tension. Next, the ankle is passively placed in dorsiflexion so that the gastrosoleus muscle is stretched, and the tendon is attached to the Achilles tendon with 30% tension. The two ends of the Y cut and the end of the tip are also installed without any tension. The length of the tip is determined in such a way that the end of the tip is placed in the distal part of the popliteal cavity. For the hamstring muscle, the tip is cut in an I shape. The beginning of the tendon is closed at the insertion of the hamstring muscle without any tension. The continuation of the band along the hamstring muscle is attached with 30% tension, and the end of the band is closed without stretching at the origin of the hamstring muscle. Kinesiotape remains for 48 hours and then it is opened.
Category
Treatment - Devices
2
Description
Control group: Sham taping (kinesiotape without stretching and appropriate technique) is performed in the control group. After 48 hours, the bandage is opened.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Maryam Najafi
Street address
Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8587
Email
hosp_sina@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Abolhasani
Street address
Sina hospital, Imam Khomeini Ave
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8587
Email
dr_m_abolhasani@yahoo.com
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
Maryam Najafi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Rehabilitation management
Street address
Sina Hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8587
Email
m_najafi@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Abolhasani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Rehabilitation management
Street address
Sina Hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8587
Email
dr_m_abolhasani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Najafi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Rehabilitation management
Street address
Sina Hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8587
Email
m_najafi@razi.tums.ac.ir
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available