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Comparison of autologous blood transfusion with methylprednisolone injection in the treatment of patients with plantar fasciitis

Protocol summary

Study aim
1. Determining and comparing the effect of methylprednisolone injection and autologous blood transfusion in the treatment of patients with plantar fasciitis by age 2. Determining and comparing the effect of methylprednisolone injection and autologous blood transfusion in the treatment of patients with plantar fasciitis by sex 3. Determining and comparing the effect of methylprednisolone injection and autologous blood transfusion in the treatment of patients with plantar fasciitis according to the presence of underlying disease 4. Determining and comparing the effect of methylprednisolone injection and autologous blood transfusion in the treatment of patients with plantar fasciitis according to the duration of the disease
Design
Interventional single blinded Simple randomized study, In two groups of 45 patients with plantar fasciitis during 2019 to 2021
Settings and conduct
Two groups of 45 patients with plantar fasciitis referred to the orthopedic clinic of Shahid Beheshti Hospital in Babol randomly receive methylprednisolone or autologous blood
Participants/Inclusion and exclusion criteria
inclusion criteria includes; Age over 18 years, heel pain for at least 4 weeks, pain intensity more than 5 based on visual analog scale index, tenderness at the junction of plantar fascia with calcaneus, ability to follow up for 6 months after starting treatment and informed written consent exclusion criteria includes; Heel surgery, evidence for calcaneus fracture, nerve damage, Achilles tendon injury, rheumatoid arthritis, local or systemic infection, peripheral vascular dysfunction, gout, coagulation disorder, pregnancy or lactation, corticosteroid injection in the last 3 months, non-steroidal anti-inflammatory drug uses In the last 7 days, history of allergy to injectable solutions
Intervention groups
Autologous blood group
Main outcome variables
Pain control

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160508027797N7
Registration date: 2020-11-29, 1399/09/09
Registration timing: registered_while_recruiting

Last update: 2020-11-29, 1399/09/09
Update count: 0
Registration date
2020-11-29, 1399/09/09
Registrant information
Name
Masoud Bahrami Ferydoni
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
m.bahrami@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of autologous blood transfusion with methylprednisolone injection in the treatment of patients with plantar fasciitis
Public title
The effect of autologous blood on plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Heel pain for at least 4 weeks Pain intensity greater than 5 based on visual analog scale index Tenderness at the junction of plantar fascia with calcaneus Having the ability to follow up for 6 months after starting treatment Conscious written consent
Exclusion criteria:
Heel surgery Evidence in favor of calcaneus fracture Nerve damage Achilles tendon injury Rheumatoid Arthritis Local or systemic infection Peripheral vascular disorder Gout Coagulation disorder Pregnancy or breastfeeding Corticosteroid injection in the last 3 months Use of non-steroidal anti-inflammatory drugs in the last 7 days History of allergy to injectable solutions
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: Envelopes and codes are prepared for randomization and simultaneous blinding for the patients. Each pack contains the type of injection (A: autologous blood; B: corticosteroids). Packs allocated by different codes. These codes are recorded for each patient. The order of the Pockets are determined by a statistician. After the patient enters the study, the pack is opened and the treatment for that patient is beginning.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher and evaluator is unaware of the type of treatment and the statistician randomly determines the type of treatment of patients from a pre-prepared envelope
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol university of medical science
Street address
GanjAfrooz Street
City
babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2020-04-07, 1399/01/19
Ethics committee reference number
IR.MUBABOL.REC.1399.038

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 control by autologous blood injection
Timepoint
First week, fourth week, third month, sixth month
Method of measurement
visual analogue scale index, role and maudsley scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 45 patients with plantar fasciitis who will receive 5 cc of autologous blood at the lesion site.
Category
Treatment - Drugs

2

Description
Control group: 45 patients with plantar fasciitis who will receive 40 mg of methylprednisolone injection at the lesion site.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
shahid beheshti hospital of babol university of medical science
Full name of responsible person
Masoud Bahrami-Fereydouni
Street address
GanjAfrooz street
City
babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
m.bahrami@mubabol.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
GanjAfrooz Street
City
babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 7667
Email
research@mubabol.ac.ir
Web page address
http://research.mubabol.ac.ir/
Grant name
Vice Chancellor for Research and Technology of Babol University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Masoud Bahrami-Fereydouni
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
GanjAfrooz Street
City
babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
m.bahrami@mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Masoud Bahrami-Fereydouni
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
GanjAfrooz Street
City
BABOL
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
m.bahrami@mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Masoud Bahrami-Fereydouni
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
GanjAfrooz Street
City
babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
m.bahrami@mubabol.ac.ir

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
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after Clearing individuals profile
When the data will become available and for how long
After the article is officially published
To whom data/document is available
For all researchers in this field
Under which criteria data/document could be used
For studies with the wider community, review studies and meta-analysis
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
Confirmation of the person in charge of the study
Comments
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