Evaluation of the effect of kinesiology tape versus phonophoresis with hydrocortisone 1% on painful Hallux valgus
Design
Randomized Clinical trial with parallel groups
Settings and conduct
This study is performed on 40 people in Physical medicine and rehabilitation clinics affiliated to Isfahan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Satisfaction to participate in the study; Patients with painful Hallux valgus with a mild and moderate degree of severity and without limitation in the abduction of the thumb; Exclusion criteria: Having diseases like rheumatoid arthritis, gout and mucus; A history of diabetes; History of diseases of neuropathy in lower extremity; History of dislocation or fracture in metatarsophalangeal joints; Taking high doses of corticosteroids; Taking anticoagulant drugs; Drug addiction; Having a history of previous Hallux valgus surgery or a history of lower extremity surgery that leads to imbalance; Intense Hallux valgus; Contraindication of using ultrasound.
Intervention groups
Patients are divided into two groups of 20 patients. Intervention group1: a group treated with the kinesiology tape for eight weeks (twelve times every five days) and Intervention group2: treated with phonophoresis using pulses (1 to 4) with a frequency of one megahertz and intensity w/cm²1, in the presence of hydroquitizon 1%, every 10 minutes, three times a week for one month.
Main outcome variables
Severity of pain; function; angle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N7
Registration date:2019-04-24, 1398/02/04
Registration timing:prospective
Last update:2019-04-24, 1398/02/04
Update count:0
Registration date
2019-04-24, 1398/02/04
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-30, 1398/02/10
Expected recruitment end date
2019-12-11, 1398/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of kinesiology tape versus phonophoresis with 1% hydrocortisone on painful Hallux valgus
Public title
The effect of kinesiology tape versus phonophoresis on painful Hallux valgus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Patients with painful Hallux valgus, with a mild and moderate degree of severity (the angle of Hallux valgus is 40 or less and the angle of IMA is 15 or less) and without limitation in the abduction of the thumb
Exclusion criteria:
Having diseases like rheumatoid arthritis, gout, mucus
A history of diabetes
History of diseases of neuropathy in lower extremity
History of dislocation or fracture in metatarsophalangeal joint
Taking high doses of corticosteroids
Taking anticoagulant drugs
Drug addiction
Having a history of previous Hallux valgus surgery or a history of lower extremity surgery that leads to imbalance. Intense Hallux valgus (Hallux valgus angle is more than 40 and IMA angle is more than 15 and the limitation in thumb abduction)
Contraindication of using ultrasound (acute inflammation, infection, bleeding)
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Cases are randomized using random allocation through the software. In this way, after the selection of 40 people that have the inclusion criteria, people are randomly assigned to one of the two intervention groups by statistical software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.MUI.MED.REC.1397.355
Health conditions studied
1
Description of health condition studied
Hallux valgus
ICD-10 code
M20.1
ICD-10 code description
Hallux valgus (acquired)
Primary outcomes
1
Description
Severity of pain
Timepoint
Before treatment, one week and two months after treatment
Method of measurement
VAS (Visual analogue scale)
2
Description
Function
Timepoint
Before treatment, one week and two months after treatment
Method of measurement
MOXFQ
3
Description
Angle
Timepoint
Before and a week after study
Method of measurement
Goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: a group treated with the kinesiology tape for eight weeks (twelve times every five days)
Category
Treatment - Devices
2
Description
Intervention group: treated with phonophoresis using pulses (1 to 4) with a frequency of one megahertz and intensity w/cm²1, in the presence of hydroquitizon 1%, every 10 minutes, three times a week for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy and Rehabilitation Clinics of Isfahan University of Medical Sciences
Full name of responsible person
Razie Maghroori
Street address
Office of Physical Medicine and Rehabilitation, Al-Zahra Educational Center, ,Sofe St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
pmr@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Razie Maghroori
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, School of Medicine, Kashani Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
maghroori@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Razie Maghroori
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, School of Medicine, Kashani Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
maghroori@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Razie Maghroori
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, School of Medicine, Kashani Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
maghroori@mui.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
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
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Department of Physical Medicine and Rehabilitation
What processes are involved for a request to access data/document
after the investigation of researcher request and presentation of required documents will be accessible.