Protocol summary

Summary
The aim of this study is to compare the effectiveness of local injection of autologous platelet rich plasma (PRP) and local steroid in reducing pain and improving function in patients with chronic plantar fasciitis (PF). Patients with chronic PF (n = 30) will be assigned to receive either platelet rich plasma or steroid ultrasound-guided injections.The first 15 patients will be treated by a local injection of 1 mL of 40 mg Methylprednisolone with 1 mL of 2% lidocain and the second 15 patients will be injected with 2 mL PRP. The level of pain will be evaluated using the Visual Analogue Scale (VAS) at baseline, at 3 and 8 weeks post-injection. Disability will be assessed using the Persian version of Foot and Ankle Ability Measure (FAAM) at baseline, at 3 and 8 weeks post-injection

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014011316201N1
Registration date: 2014-01-19, 1392/10/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-01-19, 1392/10/29
Registrant information
Name
Hajar Karimian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 9040
Email address
karimian_h@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciencs
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-02-18, 1392/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluating the efficacy of injection of Platelet Rich Plasma in treatment of plantar fasciitis
Public title
platelet rich plasma effect on plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with unilateral PF or pain prominent in one foot; intractable pain for a minimum of 3 months’ duration ; a VAS score of at least 4 at the insertion of the plantar fascia on calcaneus taking the first step in the morning. Exclusion criteria: usage of NSAIDs within 48 hours of procedure; corticosteroid injection at treatment site within 1 month; having any other associated pathology involving the lower limb; abnormal ESR or CRP level; any systemic disorders.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Physical Medicine and Rehabilitation ward, Shiraz University of Medical Sciencs
City
Shiraz
Postal code
Approval date
2013-12-15, 1392/09/24
Ethics committee reference number
ct-p-92-4558

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
baseline, 3 weeks, 8 weeks
Method of measurement
visual analogue score

2

Description
disability
Timepoint
baseline, 3 weeks and 8 weeks
Method of measurement
persian version of Foot and Ankle Ability Measure(FAAM)

Secondary outcomes

empty

Intervention groups

1

Description
2cc platelet rich plasma/1cc methyl prednisolon40 mg+ 1 cc lidocain 2%
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation ward, Shiraz University of Medical Sciences
Full name of responsible person
Hajar Karimian
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Physical Medicine and Rehabilitation ward, Shiraz University of Medical Sciencs
Full name of responsible person
Kaynush Homayouni
Street address
Physical Medicine and Rehabilitation ward, Shiraz University of Medical Sciencs
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine and Rehabilitation ward, Shiraz University of Medical Sciencs
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Physical Medicine and Rehabilitation ward, Shiraz University of Medical Sciences
Full name of responsible person
Hajar Karimian
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Shiraz University of Medical Science - Physical Medicine and Rehabilitation ward
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
karimian_h@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kaynush Homayouni
Position
Assistant professor
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
kayhomayouni@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hajar Karimian
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences
City
Postal code
Phone
+98 71 1231 9040
Fax
Email
karimian_h@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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