Comparison of the success rate of treatment with Depomedrol injection and extracorporeal shock waves (ESWT) in patients with heel pain due to plantar fasciitis
Comparison of the success rate of treatment with Depomedrol injection and extracorporeal shock waves (ESWT) in patients with heel pain due to plantar fasciitis in patients referred to Bouali Hospital
Design
A number of 86 patients are included in the study, so that each patient is assigned a number and randomly placed in two groups of 43 people according to the online random number table. Patient information is recorded in data collection forms and entered into SPSS version 26 statistical software. The rate of treatment success is evaluated using the Vas scale. The data is entered into the data collection form and then spss and analyzed.
Settings and conduct
The patients of the first group were treated with depomedrol injection and the second group were treated with shock wave therapy. A single dose of depomedrol 40mg/ml is injected into the heel of the foot inside the plantar fascia.for ESWT at first a ultrasonogram gel will be applied to heel and plantar fascia area .Then the device probe is placed in the heel and plantar fascia area and then treatment is performed with frequency of 1 to 20 Hz and a duration of 15 to 20 minutes.After a period of 4 months, the treatment success rate between depomedrol injection and shock wave therapy in patients was evaluated using the Vas scale.this process is done in Tehran Bouali hospital
Participants/Inclusion and exclusion criteria
admission:agree to cooperate/patient has plantar fascitis
not admit:radiculopathy/prior history of calcaneal fx/calcaneal tumor/ra and as
Heel pain caused by plantar fasciitis is evaluated using the Vas scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230807059066N1
Registration date:2023-08-21, 1402/05/30
Registration timing:prospective
Last update:2023-08-21, 1402/05/30
Update count:0
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
Alireza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7763 3714
Email address
al.hashemian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-22, 1402/05/31
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the success rate of treatment with Depomedrol injection and extracorporeal shock waves (ESWT) in patients with heel pain due to plantar fasciitis
Public title
Comparison of the success rate of treatment with Depomedrol injection and extracorporeal shock waves (ESWT) in patients with heel pain due to plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient has plantar fascitis
patient agree to cooperate
Exclusion criteria:
radiculopathy
AS and RA
prior history of calcaneal fx
calcaneal tumor
advanced neuropathy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
method : Simple randomization
Random sequence generation: by using random number table
from top to bottom ,even numbers belong to group a and odd numbers belong to group b
Allocation concealment :central randomization
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 Azad Tehran medical university
Street address
NO.9,Attarimoghadam Ave. ,Shariati Street, Tehran Town
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2022-08-15, 1401/05/24
Ethics committee reference number
IR.IAU.TMU.REC.1401.165
Health conditions studied
1
Description of health condition studied
plantar fascitis
ICD-10 code
M72.2
ICD-10 code description
Other fibroblastic disorders
Primary outcomes
1
Description
score of disability due to plantar fasciitis by Oxford foot disability index
Timepoint
start of treatmet and 2 till 4 months after treatment
Method of measurement
oxford foot disability score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group a which is chosen by simple randomization and referred to physiotherapy for extracorporeal shock wave therapy that has a device put in contact with skin of heel and produce shockwave with frequency of 10ms and amplitude of 76 map
Category
Treatment - Devices
2
Description
Control group: group b : Depomedrol 40mg amp injected in the heel of the injured leg at the clinic
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali hospital Tehran
Full name of responsible person
Alireza Hashemian
Street address
Damavand Street
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Fax
+98 21 3378 6182
Email
booali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Masoud Parsania
Street address
NO.9,Attarimoghadam Ave. ,Shariati Street, Tehran Town
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2200 6660
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Alireza Hashemian
Position
medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
No.6, Kafaeiamani Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
1155676313
Phone
+98 21 7763 3714
Email
al.hashemian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Hashemian
Position
medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
No.6, Kafaeiamani Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
1155676313
Phone
+98 21 7763 3714
Email
al.hashemian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Hashemian
Position
medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
No.6, Kafaeiamani Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
1155676313
Phone
+98 21 7763 3714
Email
al.hashemian@gmail.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