Evaluation of effect of lowdye taping on pain and function in individuals with plantar fasciitis in patients of Iran medical sciences university hospitals
Comparison of the effect of taping on pain and function of patients with plantar fasciitis
Design
A randomized clinical trial with a control group. Randomization is done in the form of a table of random numbers, and blinding of participants is performed.
28 participants (14 individuals in each group). Randomization by table of random numbers.
Settings and conduct
This study takes place in Firoozgar Hospital, Tehran, Iran as a randomized clinical trial on patients with plantar fasciitis
Participants/Inclusion and exclusion criteria
The Inclusion criteria: patients referred to Firouzgar Hospital in Tehran who have been diagnosed with plantar fasciitis.
1- Pain in touching the plantar fascia should be reported 2- Pain should be local and sharp but not referral in nature 3- Pain worsens after the first few steps after a long rest 4- Pain improves after taking several steps but intensifies again with resuming activity 5- No allergy to taping
The exclusion criteria: 1- History of steroid injection 2- Previous surgery, in the leg or lumbar disc 3- Description of rheumatologic diseases 4- The presence of deformity and other acquired congenital problems such as diabetes and flat feet 5- Performing other therapeutic interventions during the study.
Intervention groups
Patients are divided into two intervention and control groups. All patients receive pre-fabricated longitudinal-inner arch vinyl acetate stretching and orthopedic insoles with a hardness of 50 and a foam surface with a hardness of 30 and a leather surface suitable for the patient’s size for daily activities that involve weight-bearing for 4 weeks before receiving the intervention.
In addition to the above measures, the intervention group receives taping in 4 sessions with weekly replacement.
Main outcome variables
Adding a cost-effective method, increasing effectiveness, and improving quality of life and pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090311001760N49
Registration date:2023-07-18, 1402/04/27
Registration timing:prospective
Last update:2023-07-18, 1402/04/27
Update count:0
Registration date
2023-07-18, 1402/04/27
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of lowdye taping on pain and function in individuals with plantar fasciitis in patients of Iran medical sciences university hospitals
Public title
Evaluation of effect of lowdye taping on pain and function in individuals with plantar fasciitis in patients of Iran medical sciences university hospitals
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain in plantar fascia
Non-radicular local sharp pain
Worsening of pain with first steps after long rest
Reduction of pain after few steps and worsening after continued activity
Absence of history of allergic reaction to taping material
Exclusion criteria:
Steroids injection history
History of prior podiatric or lumbar surgeries
Rheumatologic disease history
Congenital or acquired deformities of foot such as diabetic foot or pes planus
Other therapeutic interventions at the time of study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by a random numbers table. Then the numbers are placed in sealed envelopes, and neither the participant nor the analyzer knows about the numbers. Each patient chooses one of the envelopes. Due to the use of sham taping, participants are blinded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and analyzers do not know about each group's type.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
5th floor Central building of Iran university of medical science, West Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-11-05, 1401/08/14
Ethics committee reference number
IR.IUMS.FMD.REC.1401.406
Health conditions studied
1
Description of health condition studied
Plantar fasciitis
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis
Primary outcomes
1
Description
Pain evaluation
Timepoint
Beginning of study (Before intervention), weeks 1 and 4
Method of measurement
Foot Function Index (FFI) and Self Administered Foot Evaluation Questionnaire (SAFE)
2
Description
Morning pain
Timepoint
Beginning of study (Before intervention), weeks 1 and 4
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Function
Timepoint
Beginning of study (Before intervention), weeks 1 and 4
Method of measurement
Foot Function Index (FFI)
Intervention groups
1
Description
Intervention group: All patients receive pre-made stretching and insole exercises with longitudinal-inner arches made of ethyl vinyl acetate with a hardness of 50 and a foam surface with a hardness of 30 and a leather surface suitable for the patient’s size for daily activities that involve weight-bearing for 4 weeks before receiving intervention. In addition to the above measures, the intervention group receives taping in 4 sessions with weekly replacement.
Category
Treatment - Devices
2
Description
Control group: In the control group, patients receive stretching and medical insole exercises along with sham taping with similar patient visits as the intervention group. In this case, two non-stretching bands are randomly placed and it is tried to be visually similar to the intervention group as much as possible so that the participants are blinded.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Mitra Alizadeh
Street address
Beh-aafarin street, Vali-e-asr square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1000
Email
firoozgarhospital1@gmail.com
Web page address
https://firoozgar.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Falak
Street address
Iran university of medical science, West Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@iums.ac.ir
Web page address
https://iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mitra alizadeh
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Etemad st, north Jamalzadeh st
City
Tehran
Province
Tehran
Postal code
1418835589
Phone
+98 21 6690 8238
Email
alizadeh.mitra90@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Alizadeh
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Etemad st, north Jamalzadeh st
City
Tehran
Province
Tehran
Postal code
1418835589
Phone
+98 21 6690 8238
Email
alizadeh.mitra90@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Alizadeh
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Etemad st, north Jamalzadeh st
City
Tehran
Province
Tehran
Postal code
1418835589
Phone
+98 21 6690 8238
Email
alizadeh.mitra90@yahoo.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