Platelet Rich Plasma in Plantar Fasciitis

Not Applicable

Completed

• Conditions: Plantar Fascitis
• Interventions: Other: platelet rich plasma; Drug: MethylPREDNISolone 40 MG

• Registration Number: NCT05339542
• Lead Sponsor: Minia University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-03-10
• Study First Submitted: 2022-04-09
• Study First Submitted QC: 2022-04-15
• Study First Posted: 2022-04-21
• Status Verified: 2022-07
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-02
• Last Update Submitted: 2022-07-02
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet rich plasma group	platelet rich plasma	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.
Methylprednisolone group	MethylPREDNISolone 40 MG	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.

Primary Outcome Measures

Name	Time	Method
visual analogue scale	3 months	visual analogue scale from 0-10, where 0 denoting maximum pain relief and 10 denoting no pain relief
Manchester-Oxford Foot Questionnaire	3 months	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)

Secondary Outcome Measures

Name	Time	Method
echogenicity in longitudinal scan gray scale ultrasound	3 months	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
plantar fascia thickness at the insertion in longitudinal scan of the heel	3 months	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

Trial Locations

Locations (1)

Minya university; 🇪🇬 Minya, Egypt