Platelet Rich Plasma in Plantar Fasciitis

Study Overview
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Brief Summary
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a number of patient diagnosed as degenerative plantar fasciitis will be collected and divided into two groups, group I will be injected by platelet rich plasma and group II will be injected methylprednisolone

Detailed Description
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the study will include 100 patients diagnosed as degenerative plantar fasciitis and will be evaluated by musculoskeletal ultrasound by two observes and the will divided randomly into two groups who will be injected under ultrasound imaging by either Platelet rich plasma or methylprednisolone. selection of patient will be randomly and the study will be double blinded.

Official Title
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Musculoskeletal Ultrasound Changes in the Plantar Fascia After a Single Injection of Platelet Rich Plasma Compared to Steroid

Conditions
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Plantar Fascitis

Intervention / Treatment
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* Other: platelet rich plasma
* Drug: MethylPREDNISolone 40 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: * Clinical diagnosis of plantar fasciitis Exclusion Criteria (history or current): Rheumatic diseases Foot Trauma Neurological diseases Thyroid disease Diabetes mellitus Chronic Renal Failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: the study will include two groups. Group I (study group) will be injected PRP. Group II (control group) will be injected methylprednisolone
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet rich plasma group<br>platelet rich plasma (PRP) will be produced through whole blood centrifuge using a specific methodology in a strict aseptic setting. Then, blood will be collected and mixed with anticoagulant and Citrate-phosphate-dextrose adenine in a 10 volume blood to 1 volume anticoagulant ratio. The blood will be centrifuged for 10 minutes at 1000 rpm. Afterward, the plasma will be transferred to a new glass tube and centrifuged for 15 minutes at 3000 rpm. At the bottom of the tube, platelets will form a pellet. Finally, pure platelet-rich plasma will be obtained at a concentration of up to four times higher than baseline. Prior to the injection, calcium gluconate will be combined with PRP (at a ratio of 0.3 ml ca gluconate/ml PRP). The injection will be done once. | Other: platelet rich plasma<br>* derived from patient own blood<br>|
| Active Comparator: Methylprednisolone group<br>2 ml methylprednisolone acetate 40mg/ml (total 80mg methylprednisolone acetate) together with 1 ml lidocaine 2% (total 3 ml solution) will be directly injected under ultrasound guidance to the plantar fascia.This group serves as active comparative group. The injection will be done once. | Drug: MethylPREDNISolone 40 MG<br>* active comparative intervention<br>* Other names: 1 ml Lidocaine 2%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale | visual analogue scale from 0-10, where 0 denoting maximum pain relief and 10 denoting no pain relief | 3 months | 
| Manchester-Oxford Foot Questionnaire | the Manchester-Oxford Foot Questionnaire is a 16-item instrument answered on a five-point Likert scale (each item is scored from 0 to 4, with 4 denoting 'most severe'). Scores for each item are summed to form three separate sub scales representing underlying domains: walking/standing problems (seven items), foot pain (five items), and issues related to social interaction (four items) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| echogenicity in longitudinal scan gray scale ultrasound | Hypoechogenicity was defined as a lack of the homogeneous fibrillar pattern with loss of the tightly packed echogenic lines after correcting for anisotropy. increased echogenicity is consistent with plantar fasciitis | 3 months | 
| plantar fascia thickness at the insertion in longitudinal scan of the heel | measurement of plantar fascia thickness at the insertion in longitudinal view of the heel. Normal thickness is ≤ 4mm. increased thickness is consistent with plantar fasciitis | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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degenerative plantar fasciitis, platelet rich plasma, ultrasound guided injection, heel pain, interventional rheumatology