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Comparison of effectiveness between Corticosteroid and Hyaluronic acid injection in treatment of patients with Plantar fasciitis

Protocol summary

Study aim
Comparing the efficacy of injecting single dose of high-molecular-weight hyaluronic acid versus corticosteroid at the site of heel on pain, function، pressure pain threshold and thickness of plantar fascia among patients with plantar fasciitis
Design
Randomized double blind clinical trial with two parallel groups and 20 patients in each group. Randomization will be done by the means of table of random numbers.
Settings and conduct
In this study patients who are diagnosed with plantar fasciitis will be randomly allocated into two groups of 20 patients based on the table of random numbers. In one group high molecular weight hyaluronic acid and in the other group corticosteroid will be injected into the plantar fascia with the guide of ultrasound. The assessment of the pain, function, pressure pain threshold and the thickness of plantar fascia with ultrasound will be done before injection and 2 and 6 months after injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients diagnosed with plantar fasciitis, aged 25-60 years old who have not respond to initial conservative treatment. Non inclusion criteria: Pregnancy,Taking Corticosteroids (oral route) or in past 3 weeks or injecting corticosteroids at the site of plantar fascia in past 6 months, History of vasovagal syncope, Being hemodynamically unstable, Recent skin or soft tissue infection at the site of injection, Heel pain due to neuropathy or radiculopathy, History of Diabetes Mellitus, Fracture in surrounding bones, Having other diseases which can cause heel pain such as Ankylosing Spondylitis or other inflammatory disorders, History of surgery at Plantar Fascia
Intervention groups
A single injection of high-molecular-weight hyaluronic acid in one group and a single injection of corticosteroid in the other the heel.
Main outcome variables
pain, function, pressure pain threshold, the thickness of plantar fascia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130523013442N26
Registration date: 2018-09-18, 1397/06/27
Registration timing: registered_while_recruiting

Last update: 2018-09-18, 1397/06/27
Update count: 0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-25, 1397/05/03
Expected recruitment end date
2018-10-27, 1397/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness between Corticosteroid and Hyaluronic acid injection in treatment of patients with Plantar fasciitis
Public title
Effect of Hyaluronic acid injection in treatment of Plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diagnosis of Plantar fasciitis who are visited at the Physical medicine & Rehabilitation clinic of Shahid Modarres hospital Age between 25-60 years old Having the pain since 3 months ago or more Not responding to initial conservative treatments such as shoe insoles, excercise and NSAIDs Willing to participate in the study
Exclusion criteria:
Pregnancy Taking Corticosteroids or NSAIDs (oral route) in past 3 weeks or injecting corticosteroids at the site of plantar fascia in past 6 months History of vasovagal syncope Being hemodynamically unstable Recent skin or soft tissue infection at the site of injection Heel pain due to neuropathy or radiculopathy History of Diabetes Mellitus Fracture in surrounding bones Having other diseases which can cause heel pain such as Ankylosing Spondylitis or other inflammatory disorders History of surgery at Plantar Fascia
Age
From 25 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly placed in two groups of receiving Hyaluronic acid or Corticosteroid injection by using table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants are unaware of exact the type of the injected drug and since the physician who inject the drug and the one who follow up them are different, the later is blinded about the injected drug.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Shahid Arabi street, Yaman street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1958717443
Approval date
2018-07-25, 1397/05/03
Ethics committee reference number
IR.SBMU.MSP.REC.1397.403

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
heel pain
Timepoint
Before intervention and 2 & 6 months after injection
Method of measurement
Visual Analogue Scale questionnaire

Secondary outcomes

1

Description
Pressure Pain Threshold
Timepoint
Before intervention and 2 & 6 months after injection
Method of measurement
Algometer

2

Description
Effect of the pain on function
Timepoint
Before intervention and 2 & 6 months after injection
Method of measurement
Foot and Ankle Ability Measure (FAAM) questionnaire

3

Description
Plantar fascia thickness in vertical and horizontal sections
Timepoint
Before intervention and 2 & 6 months after injection
Method of measurement
Ultrasound

Intervention groups

1

Description
Intervention group: Injection of 1ml high molecular weight Hyalorunic acid 2% (trade name "Viscor", 2500-3500 kDa, Fermentation source, 50 mg in 2.5 cc, Made in Iran) and 1 ml Lidocaine 2%, injection in the heel , injection with the guide of ultrasound, single injection
Category
Treatment - Drugs

2

Description
Control group: Injection of 1 ml Methyl prednisolone acetate & 1 ml Lidocaine 2%, injection in the heel , injection with the guide of ultrasound, single injection
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Seyyed Ahmad Raeissadat
Street address
Saadat Abad street
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2236 3244
Email
a_raeissadat@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice chancellor for research
Street address
Saadat Abad street
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2236 3244
Email
a_raeissadat@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahtab Darvish
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1953754163
Phone
+98 21 2283 2343
Email
mahtab.darvish@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Associate Professor of Physical Medicine and Rehabilitation departmen, Shahid Beheshti University of
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shahid Arabi Ave., Yaman St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
a_raeissadat@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahtab Darvish
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1953754163
Phone
+98 22832343
Email
mahtab.darvish@sbmu.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
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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