Protocol summary

Study aim
Comparative efficacy of corticosteroid injections versus laser therapy in patients with plantar fasciitis attending to Imam Hossein hospital in 2017
Design
This clinical trial study was conducted in 50 patients with plantar fasciitis. This study was conducted with parallel groups, without blindness, and randomized with simple random sampling and in Phase 3 trials.
Settings and conduct
This study is a randomized clinical trial. And among patients with plantar fasciitis referred to orthopedic clinic of Imam Hossein Shahrood Hospital in 96 and 97 years. And this study is without blindness.
Participants/Inclusion and exclusion criteria
inclusion criteria: All patients with Plantar Fasciitis exclusion criteria: History of diabetes mellitus disease, History of any type of fracture, Congenital deformity history
Intervention groups
Intervention group: Low-power laser therapy is performed under 10 sessions. Control group: Injection of methylprednisolone 40 mg at the site of the lesion (maximum heel pain).
Main outcome variables
Pain score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180101038180N1
Registration date: 2018-03-04, 1396/12/13
Registration timing: registered_while_recruiting

Last update: 2018-03-04, 1396/12/13
Update count: 0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Hamidreza Azarnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4448 1660
Email address
azarnia@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-08, 1396/08/17
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of corticosteroid injections versus laser therapy in patients with plantar fasciitis attending to Imam Hossein hospital in 2017
Public title
Comparative efficacy of corticosteroid injections versus laser therapy in patients with plantar fasciitis attending
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with Plantar Fasciitis
Exclusion criteria:
History of diabetes mellitus disease History of any type of fracture Congenital deformity history
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple and each person is randomly assigned to one of the treatment groups.
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 Islamic Azad University Shahroud Branch
Street address
Islamic Azad University of Shahrood Branch, University Blvd, Shahrud
City
Shahroud
Province
Semnan
Postal code
4318936199
Approval date
2017-11-07, 1396/08/16
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1396.31

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 score
Timepoint
At the beginning of the intervention (before the intervention) and 6 weeks after the end of the treatment
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Low-power laser therapy is performed under 10 sessions.
Category
Treatment - Other

2

Description
Control group: Injection of methylprednisolone 40 mg at the site of the lesion (maximum heel pain).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahroud Imam Hussein Hospital
Full name of responsible person
Mahdiyeh Malvandi
Street address
Ayatollah Tohidi Street, Imam Street, ُُShahroud
City
Shahroud
Province
Semnan
Postal code
3616659934
Phone
+98 23 3234 2000
Email
Mahdie.malvandi90@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahebali Manafi
Street address
Islamic Azad University of Shahroud, University blvd, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616659934
Phone
+98 23 3239 4530
Email
Mahdie.malvandi90@gmail.com
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
Mahdiyeh Malvandi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 89, Azadegan Fifth Alley, Azadegan Avenue, shahroud
City
Shahroud
Province
Semnan
Postal code
3616659934
Phone
+98 930 315 1282
Email
Mahdie.malvandi90@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Roozbeh Taghavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Ayatollah Tohidi Street, Imam Street, ُُShahroud
City
ُُShahroud
Province
Semnan
Postal code
3616659934
Phone
+98 23 3234 2000
Email
Mahdie.malvandi90@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahdiyeh Malvandi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 89, Azadegan Fifth Alley, Azadegan Avenue, shahroud
City
ُShahroud
Province
Semnan
Postal code
3616659934
Phone
+98 51 4441 0084
Email
Mahdie.malvandi90@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
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