Investigating the effect of Tacar treatment on improving symptoms and performance of patients with plantar fasciitis and comparing it with drug treatment
Determining the therapeutic effect of Tecar on improving the symptoms and performance of patients with plantar fasciitis
Design
A parallel blind randomized clinical trial study in 1402-1403 on 60 patients diagnosed with plantar fasciitis who were randomly assigned to one of 2 intervention groups.
Settings and conduct
In this blinded study, plantar fasciitis patients who have pain for at least one month and VAS score more than 3 and are referred to physical medicine clinics of Isfahan University of Medical Sciences in 1402-1403 will be treated randomly (with information and agreement of the treatment method considered by each patient) and after the completion of sampling of all data by an analyst who is not aware of the division of groups and treatment methods, the results will be analyzed.
Participants/Inclusion and exclusion criteria
1-Diagnosis of plantar fasciitis (worsening of the pain in the inner part of the heel in the morning after waking up and also after a lot of activity during the day ) by a specialist in physical medicine and rehabilitation with a physical examination (33) ).
2. Heel pain for at least 4 weeks
3. Age between 18 and 68 years
4. Presence of VAS more than 3
5. Informed written consent to participate in the study
Intervention groups
1- Intervention group: tacar therapy (8 sessions: 2 days per week) and exercise (including stretching of the plantar calf muscles, passive dorsiflexion of the fingers, strengthening of the intrinsic foot and rolling muscles, 9 times a day including 3 times in the morning, 3 times in the afternoon, 3 times in the evening load 30 seconds) and (Soft medial longitudinal arch support or Silicon Heel Pad) along with medicine (Celecoxib 200 mg, once a day for 15 days) are prescribed.
2- Control group: All previous cases except tacar therapy (8 sessions: 2 days per week)
Main outcome variables
pain and function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231105059968N1
Registration date:2024-01-22, 1402/11/02
Registration timing:prospective
Last update:2024-01-22, 1402/11/02
Update count:0
Registration date
2024-01-22, 1402/11/02
Registrant information
Name
Fatemeh Izadi najafabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3772 5602
Email address
fatemeh.izadi68@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Tacar treatment on improving symptoms and performance of patients with plantar fasciitis and comparing it with drug treatment
Public title
The therapeutic effect of Tecar on patients with plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of plantar fasciitis (worsening of the pain in the inner part of the heel in the morning after waking up and also after a lot of activity during the day and the presence of local tenderness in the lower inner part of the calcaneus) by a physical medicine and rehabilitation specialist with a physical examination
Heel pain for at least 4 weeks
Age between 18 and 68 years
Presence of VAS greater than 3
Informed written consent to participate in the study
Exclusion criteria:
History of inflammatory joint disease
Achilles tendon or nerve damage
History of heel surgery or injection in the last 6 months
History of injury to the affected heel
The presence of diseases mimicking the symptoms of plantar fasciitis
Contraindications of the Tecar device (pregnancy, pacemaker, insulin pump, growth plate, cancer, open wound and skin lesions, skin sensitivity, insensitivity to heat)
Patients with intense physical activity or sports who are unable to reduce their activity level
Age
From 18 years old to 68 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who will enter the study phase will be randomly assigned to one of the two intervention groups. The randomization method is that 25 random numbers from 1 to 50 are created by random number generation software, which are assigned to the first intervention group, and then the remaining 25 numbers are assigned to the second group.
Blinding (investigator's opinion)
Single blinded
Blinding description
data analysts are unaware of which group each patient was placed in.
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 Science
Street address
Hezarjerib ave, Isfahan University of Medical Science
City
isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2023-10-19, 1402/07/27
Ethics committee reference number
IR.MUI.MED.REC.1402.264
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
Timepoint
The severity of symptoms and performance of patients before the treatment will be measured again immediately after the end of the treatment and 2 months after the end of the treatment.
Method of measurement
Pain level of patients by Visual Analogue Scale questionnaire - intensity of symptoms and performance of patients by RM(The modified Roles and Maudsley) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tecarotherapy (8 sessions: 2 days a week) and exercise (including stretching of calf muscles, plantar fascia, passive dorsiflexion of fingers, strengthening of intrinsic foot muscles and rolling soles, 9 times a day, including 3 times in the morning, 3 times in the afternoon, 3 times in the evening, 30 seconds each time) and (Soft medial longitudinal arch support or Silicon Heel Pad) is prescribed along with medicine (Celecoxib 200 mg, once a day for 15 days).
Category
Treatment - Other
2
Description
Control group: Exercise (including stretching of calf muscles, plantar fascia, passive dorsiflexion of fingers, strengthening of intrinsic foot muscles, rolling soles, 9 times a day, including 3 times in the morning, 3 times in the afternoon, 3 times at night, 30 seconds each time) along with medicine (Celecoxib 200 mg, once a day) for 15 days) and (Soft medial longitudinal arch support or Silicon Heel Pad) are prescribed. After the completion of the treatments, the pain level of the patients by VAS), the severity of the symptoms and the performance of the patients by the RM questionnaire will be measured again immediately after the end of the treatment and 2 months after the end of the treatment and with the other group and also at the beginning of the treatment under Comparison will be made.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Razieh Maghroori
Street address
Sonbulestan Alley, ibne Sina Street, Shohada Square
City
isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3112 2020
Email
ramaghroori@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Building 4, Hezar Jarib Street, Isfahan University of Medical science
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
askari@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
Razieh Maghroori
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Hezar jarib Street, Isfahan University of Medical Science and health services
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
ramaghroori@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Izadi Najafabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Isfahan university of medical science, Hezarjarib Ave
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Fatemeh.izadi68@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Izadi Najafabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Isfahan university of medical science, Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
ramaghroori@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
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