Evaluation of the immediate effect of kinesio-tape on gastroc-soleus H reflex recruitment curve and performance in athletes with gastroc-soleus trigger point
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 21 patients, enrolled between January 2020 and January 2021.
Settings and conduct
The study will be conducted at the Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences. The way to get blind will be that patients will not know which group they are in. The outcome assessor will also not be aware of how groups are allocated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Athletes with leg pain in the 22-35 year age range
Exclusion criteria: any other lower extremity disorders and neuromuscular disorders of the limbs and spine, a history of physiotherapy and medication for leg pain and addiction
Intervention groups
Patients will be randomly assigned into two groups. In the first group, the first day, a Y strip Kinesio-tape will be attached to the lower leg by real stretching from calcaneus to the knee joint. On the second day, after 48 hours, the Sham kinesio-tape will be applied to the related area in the same way as the first day it is applied but without stretching. In the second group, the first day, the Sham kinesio-tape and the second day after 48 hours, the real kinesio-tape will be applied to the lower leg as described above. So the first group is the placebo-real kinesio-tape application and the second group is the placebo-real.
Main outcome variables
pain, performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029264N8
Registration date:2020-01-24, 1398/11/04
Registration timing:registered_while_recruiting
Last update:2020-01-24, 1398/11/04
Update count:0
Registration date
2020-01-24, 1398/11/04
Registrant information
Name
Rasool Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
rasool.bagheri@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate The Immediate effects of Kinesiotaping on the H-reflex recruitment parameters & performance in athletic with gastronomies trigger point
Public title
Effect of kinesiology tape on the lower leg pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least two years experience in sports
The presence of trigger point in the gastrocnemius muscle
Have a normal BMI
Exclusion criteria:
Having a history of fracture and surgery in the lower extremities and spine
Achilles tendinopathy
Having any rheumatic and skin problems
Alcohol and Cigarette Addiction.
Lumbago and radiculopathy
fibromyalgia syndrome
Age
From 22 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
21
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by simple randomization using the throwing a coin. Patients will be assigned to control group (tail) and to treatment group (head), respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients will be blind as they will not know in which group they are because both groups of Kinesio-tape will be applied to the same area of the leg.
Placebo
Used
Assignment
Crossover
Other design features
Participants in the first group will receive the real kinesio-tape on the first day of the study and placebo in the second day of the study and the second group will receive the placebo on the first day of the study and the real kinesio-tape on the second day of the study, so the design will be crossover.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comitee of Semnan University of Medical Sciences
Street address
Basij Blvd, Semnan, Semnan Province.
City
Semnan
Province
Semnan
Postal code
3513135111
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.SEMUMS.REC.1398.158
Health conditions studied
1
Description of health condition studied
lower leg pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
pre and post intervention
Method of measurement
100-milimeters numbering pain rating scale
2
Description
performance
Timepoint
pre and post intervention
Method of measurement
Jump height test
Secondary outcomes
1
Description
H-reflex recruitment curve
Timepoint
Pre, during and post intervention
Method of measurement
H reflex registration instrument
Intervention groups
1
Description
Intervention group: in this group, a Y strip kinesio-tape will be applied from distal to the proximal on the posterior leg.
Category
Rehabilitation
2
Description
Control group: in this group, a Y-strip kinesio-tape will be applied on the posterior leg as the same way of real tape without stretching.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center,. Semnan University of Medical Scinces., Semnan., Iran.
Full name of responsible person
Dr Rasool Bagheri
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3336 4180
Email
Rasool.bagheri@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaei
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3356 4180
Email
Rasool.bagheri@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mina Gholami
Position
Ms student
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3356 4180
Email
Rasool.bagheri@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mina Gholami
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3356 4180
Email
Rasool.bagheri@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mina Gholami
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3356 4180
Email
Rasool.bagheri@ymail.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