The effect of kinesio tape and low dye tape on pain and function of patients with plantar fasciitis
Design
A clinical trial with a control group, parallel groups, single-blind, randomized, on 60 patients, block randomization method was used for randomization.
Settings and conduct
This study is a single blind randomized clinical trial .
The study population includes people who will refer to the sports medicine department of Imam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Being 20 to 75 years old
No history of any disease or bone fracture or surgery that affects the development, diagnosis and treatment of plantar fasciitis.
Patient informed consent
Exclusion criteria:
Having a history of any disease or bone fracture and surgery that affects the development, diagnosis and treatment of plantar fasciitis.
Dissatisfaction with enrollment
Intervention groups
The control group under typing with low dye tape and the intervention group under typing with kinesio tape type
Main outcome variables
Pain and
Foot function in everyday life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201130049545N1
Registration date:2020-12-11, 1399/09/21
Registration timing:registered_while_recruiting
Last update:2020-12-11, 1399/09/21
Update count:0
Registration date
2020-12-11, 1399/09/21
Registrant information
Name
Elham Karimi shervedani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3741 8590
Email address
drelhamkarimi89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of kinesio tape and low dye tape on pain and function in patients with plantar fasciitis
Public title
Comparison of the effect of kinesio tape and low dye tape on pain and function in patients with plantar fasciitis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Being 20 to 75 years old
No history of ankle or heel fractures
No history of ankle surgery
No diabetes
Do not use nonsteroidal anti-inflammatory drugs (NSAIDs) for one week prior to enrollment
Do not use orthoses from the time of diagnosis until enrollment
Not having any neuromuscular damage in the lower extremities that affects daily activities
Do not have any painful lesions on the foot such as bunion or cerebellum or nail growth in the tissues around the nail
No congenital defects in the lower extremities
Existence of pain in the heel for at least one month with Vas greater than or equal to 4 at the time of examination
No open sores on the soles of the feet and heels
Exclusion criteria:
Positive tunnel sign
History of systemic inflammatory disease and connective tissue
History of hernia with S1 radiculopathy
History of gout
History of surgery or injection in the last 6 months
Pain in the back of the heel associated with Achilles bursitis
Dissatisfaction with enrollment
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups using the Permuted Block Randomization method. The website https://www.sealedenvelope.com will be used to create a random sequence in the block randomization approach. Also, to hide the allocation concealment, a random sequence is provided to a specific person. The researcher then contacts the person based on the order in which the participants enter the study and asks about the random assignment of the participant to a specific group. For each intervention, a number (code) is defined and inserted on the envelope according to the random sequence created.
Blinding (investigator's opinion)
Single blinded
Blinding description
Before entering the study, the research conditions will be explained to all patients and the people who filled out the informed consent will enter the project.
In this study, patients will be divided into two groups using a table of random numbers.
Patients will not be informed about the type of tape used and the study is one-sided blind, but other people, including Hori and the researcher of the project, are fully aware of the type of patients.
Placebo
Not used
Assignment
Parallel
Other design features
Before entering the study, the research conditions will be explained to all patients and the people who filled out the informed consent will enter the project.For all patients, the relevant checklist will be filled in first including demographic information (age, sex, height, weight, body mass profile, level of physical activity, occupation, education, time of onset of pain) and plantar fasciitis risk factors. Comprehensive physical and neurological evaluations will be performed for all patients to rule out other clinical causes of foot and heel pain. All patients will also be asked about their medical history, previous medical history, and underlying medical conditions, and their findings will be carefully recorded.Then the amount of morning pain and daily pain will be marked separately by VAS criteria.Patients will determine their pain intensity based on the VAS as a degree from the 10 cm line. The patient should have at least 40 mm of pain.The American Orthopedic Foot and Ankle Scale (AOFAS) will also be used to assess performance.For pre-tape people, the pain scale is based on the VAS questionnaire and the American Foot and Ankle Association Scale (AOFAS), a clinical assessment system that measures pain and patient performance based on patient and physician perceptions, regardless of radiographic results. Will be taken.An hour later, the pain will be measured again on the above scales. 72 hours later, patients will return for taping, and before that, the above scales will be re-examined for pain.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research assistant , Ghods Street , Keshavarzi Boulevard , Tehran Town
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2020-04-30, 1399/02/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.035
Health conditions studied
1
Description of health condition studied
Plantar fasciitis
ICD-10 code
M72.2
ICD-10 code description
Inflammation of the plantar fascia
Primary outcomes
1
Description
Pain is a quantitative variable measured by the Visual Analogue Scale.
Timepoint
The measurement of the variable at the beginning of the study is before the intervention and one hour after the intervention and 72 hours after.
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Ankle function is a variable measured by the AOFAS questionnaire
Timepoint
The variable is measured before the intervention and one hour after the intervention and 72 hours after
Method of measurement
The American Orthopaedic Foot & Ankle Scale
Intervention groups
1
Description
Intervention group: Kase technique will be used in the kinesio tape group. The type used for patients will be 2-inch tape. This brigade has been approved by Dr. Kase, the creator of this technique. Two tapes of the Kinesio tape will be measured and cut. A strip from the base of the calcaneus to the metatarsals will be measured and divided into 4 to 6 strips at the end of the tip. Another strip will be measured from the outer side of the foot above the cuboid, below the plantar surface of the foot and in the antromedial direction of the distal third of the tibia. This strip will be cut I-shped with rounded corners. While the foot is in the dorsiflexion position, the tip is glued to the bottom of the heel without any stretching. The last 4 strips of the first strip will be glued to the beginning of the plantar surface with 15 to 25% tension on the beginning of the metatarsals. The second band of the Kinesio tape is I-shped on the lateral surface of the foot without any stretching and then while the foot is in the dorsiflexion position, the tape will be attached obliquely to the arch of the sole of the foot with 25% tension. The rest of the tip will be applied on the medial surface of the wrist with 15 to 25% tension. The patient will be asked to refrain from getting water on the body while it is on the body, and to be careful not to detach it from the skin while wearing the garment. In the next session, the brigade will be removed from the skin by the therapist and the subject will be carefully examined for possible skin allergies.
Category
Treatment - Devices
2
Description
Control group: In the low-dye group, this 1.5-inch tape is with the best quality straps that are of the best quality and are used by athletes around the world. Working with a zinc oxide cloth adhesive is one inch wide and is done in five steps. The starting point is the outer edge of the foot just below the little toe. The glue starts from this place and goes down to the outer edge of the foot and passes behind the heel and returns to the first place under the sole of the foot. The glue should not wrinkle on the skin, otherwise it will cause blistering. The same is done for the inside of the foot and starts from the inside of the foot just below the big toe and goes from the inside of the foot to the back of the heel and returns to its first place through the sole of the foot. Then with a series of glue We cover the transverse holes in the sole of the foot with the previous adhesives
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeyni Hospital
Full name of responsible person
Elham Karimi
Street address
Dr.gharib street , Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2282
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad ali sahraeian
Street address
Ghods street , Keshavarzi Boulevard , Tehran Town
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3685
Email
vcr@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
Elham Karimi
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
No 10, yavary alley , East orumiye street , Jomhouri square , Tehran Town
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 6691 0301
Email
drelhamkarimi89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Karimi shervedani
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
No .10,Yavary Alley, East Orumiye street, Johouri square , Tehran Town,
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 31 3741 8590
Fax
Email
drelhamkarimi89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Karimi shervedani
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
No .10,Yavary Alley, East Orumiye street, Johouri square , Tehran Town,
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 31 3741 8590
Fax
Email
drelhamkarimi89@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After completing the study
When the data will become available and for how long
After completing the study
To whom data/document is available
There is no limit
Under which criteria data/document could be used
Send resume and reason for requesting data
From where data/document is obtainable
drelhamkarimi89@gmail.com
Belongs to Elham Karimi Shervedani
What processes are involved for a request to access data/document
Send the request and use the data to the email address listed