Platelet Rich Plasma in Plantar Fasciitis (PRP)

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

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

Study Overview

• Status: Completed
• Conditions: Plantar Fascitis
• Intervention / Treatment: Other: platelet rich plasma; Drug: MethylPREDNISolone 40 MG

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Minya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet rich plasma group; 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; derived from patient own blood
Active Comparator: Methylprednisolone group; 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; active comparative intervention; Other Names: 1 ml Lidocaine 2%

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 2, 2022

Study Registration Dates

• First Submitted: April 9, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: platelet rich plasma; heel pain; ultrasound guided injection; degenerative plantar fasciitis; interventional rheumatology
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Lidocaine
• Other Study ID Numbers: Rheumatology Dep.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No