Determining the effect of platelet riched plasma injection compared with corticosteroid in the treatment of plantar fasciitis
Design
Thirty patients with plantar fasciitis examined. Plantar facia thickness was measured and recorded for diagnosis and follow-up. Anthropometric indices including height and weight and BMI calculation were performed for patients. Patients were then divided into two groups of 15: corticosteroid intervention and PRP.
This clinical trial has two intervention groups with parallel, non-random consecutive groups with block random allocation.
Settings and conduct
Sports Medicine Department of Taleghani Hospital
Participants/Inclusion and exclusion criteria
Age over 18 years
Existence of symptoms for more than 3 months
Plantar fascia thickness over 4 mm in ultrasound examination
VAS score equal to 6 and above
;
history of any rheumatic diseases
diabetes or any malignancy
Pregnancy
Existence of bleeding disorders
There is a wound or infection at the injection site
History of receiving any injection in the area during the last 3 months
Received NSAIDS during the past week
Suspicion of other diagnoses such as fractures or nerve disorders in the area
Intervention groups
First Intervention group: In this group, 1 cc of Methylprednisolone equivalent to 40mg with 1 cc of 2% Lidocaine was injected at the site of maximum tenderness.
Second intervention group: In this group, 2 cc of Platelet-riched plasma was injected at the site of maximum tenderness.
Both groups trained for appropriate exercises and patients were followed for 3 months
Main outcome variables
Significant reduction in fascia thickness following PRP injection
Significant reduction of VAS score parameter following PRP injection
Significant reduction of FADI score parameter following PRP injection
Significant reduction of RM score parameter following PRP injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220406054429N1
Registration date:2022-06-12, 1401/03/22
Registration timing:registered_while_recruiting
Last update:2022-06-12, 1401/03/22
Update count:0
Registration date
2022-06-12, 1401/03/22
Registrant information
Name
Ali Birjandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 9790
Email address
birjandi.ali68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison The effect of platelet-riched plasma versus corticosteroids injection on the treatment of plantar fasciitis
Public title
The effect of platelet-rich plasma and corticosteroids in the treatment of plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Existence of symptoms for more than 3 months
Plantar fascia thickness above 4 mm on ultrasound examination
VAS score equal to 6 and above
Exclusion criteria:
History of rheumatic diseases
Diabetes or any malignancy
Pregnancy
Bleeding disorders
Sores or infections at the injection site
History of injections during the last 3 months
Taking NSAIDS in the last week
Suspicion of other diagnoses such as fractures or nerve disorders in the area
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Beheshti university of medical science
Street address
Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.SBMU.MSP.REC.1400.513
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
Plantar fascia thickness
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Ultrasound device
2
Description
pain
Timepoint
At the beginning of the study and 1 and 3 months after the intervention
Method of measurement
Visual analogue scale questionnaire
3
Description
Foot function
Timepoint
At the beginning of the study and 1 and 3 months after the intervention
Method of measurement
Foot and Ankle disability index and Roles and Maudsley score questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: Corticosteroid injection, methylprednisolone 40 mg in a volume of 1 cc with 1 cc of 2% lidocaine, injected one time at the site of maximum tenderness
Category
Treatment - Drugs
2
Description
second Intervention group: injection of platelet riched plasma, PRP with a volume of 2 cc, injected one time at the site of maximum tenderness