The aim of this study is to evaluate the effect of platelet rich plasma (PRP) in the treatment of plantar fasciitis. Patients with chronic plantar fasciitis with no adequate response to conservative treatments are included. Patients with major medical conditions or those who received corticosteroids in the last 6 weeks are not included. Study sample consists of 32 patients referring to physical medicine clinics of Isfahan University of Medical Sciences. Patients are randomly assigned to receive either PRP or corticosteroid (methyl prednisolone 1 ml) plus lidocaine (1 ml) injections. Primary outcome is reduction in pain measured by the Visual Analogue Scale (VAS) at baseline and then 1, 3, and 6 months after treatment. Secondary outcomes are reduction in the modified Roles and Maudsley score (assessing pain and limitation of activity) measured at baseline, and then 1, 3, and 6 months after treatment, as well as plantar fascia thickness assessed by B-mode sonography before and 3 months after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041821830N1
Registration date:2015-05-10, 1394/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-10, 1394/02/20
Registrant information
Name
Lida kianimehr
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 5555
Email address
lida.kianimehr@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of platelet rich plasma in the treatment of plantar fasciitis
Public title
Platelet rich plasma for treatment of plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of between 18 and 65 years; having chronic plantar fasciitis with duration of more than 3 months; no adequate response to conservative treatments
Exclusion criteria (not inclusion criteria): history of receiving corticosteroids within the last 6 weeks; history of surgical interventions in the ankle and the heel; receiving aspirin or NSAIDs within a week ago; history of stroke within the last three months; pregnancy or breast feeding; evidence of malignancy, anemia, diabetes, hypothyroidism, peripheral neuropathy, acute infection or fever, or coagulopathies
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 the Isfahan University of Medical Sciences
Street address
Vice CHancellor of Research, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Postal code
Approval date
2013-04-30, 1392/02/10
Ethics committee reference number
393192
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
Before and 1 month, 3 months, and 6 months after treatment
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Modified Roles and Maudsley score
Timepoint
Before and 1 month, 3 months, and 6 months after treatment
Method of measurement
Modified Roles and Maudsley Scale
2
Description
Plantar fascia thickness
Timepoint
Before and 3 months after treatment
Method of measurement
B-mode sonography
Intervention groups
1
Description
Patients in the control group receive injection of 1 cc methyl prednisolone and 1 cc lidocaine at tender point of plantar fascia in medial surface of the foot
Category
Treatment - Drugs
2
Description
Patients in the intervention group receive injection of 3 cc PRP at tender point of plantar fascia in medial surface of the foot
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Medcine Clinic of Alzahra University Hospital
Full name of responsible person
Dr. Lida Kianimehr
Street address
Alzahra University Hospital, Soffeh Avenue
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mansour Siavash
Street address
Vice Chancellor of Research, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Lida Kianimehr
Position
Resident of Physical Medcine and Rehabilitaion
Other areas of specialty/work
Street address
Department of Physical Medcine and Rehabilitaion, Alzahra University Hospital, Soffeh Avenue
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
lida.kianimehr@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Babak Vahdatpour
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Alzahra University Hospital, Soffeh Avenue
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
vahdatpour@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Lida Kianimehr
Position
Resident of Physical Medcine and Rehabilitaion
Other areas of specialty/work
Street address
Department of Physical Medcine and Rehabilitaion, Alzahra University Hospital, Soffeh Avenue
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
lida.kianimehr@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)