Platelet Rich Plasma in Plantar Fasciitis

NCT05339542 | Completed DMC

• 1 other identifier: Rheumatology Dep.
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Conditions

Plantar Fascitis

Keywords

degenerative plantar fasciitis; platelet rich plasma; ultrasound guided injection; heel pain; interventional rheumatology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• echogenicity in longitudinal scan gray scale ultrasound

  3 months

• plantar fascia thickness at the insertion in longitudinal scan of the heel

  3 months

Study Arms (2)

Platelet rich plasma group

EXPERIMENTAL

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

Methylprednisolone group

ACTIVE COMPARATOR

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

Interventions

platelet rich plasma OTHER

derived from patient own blood

Platelet rich plasma group

MethylPREDNISolone 40 MG DRUG

active comparative intervention

Also known as: 1 ml Lidocaine 2%

Methylprednisolone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* Clinical diagnosis of plantar fasciitis

You may not qualify if:

• Rheumatic diseases
• Foot Trauma
• Neurological diseases
• Thyroid disease
• Diabetes mellitus
• Chronic Renal Failure

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minya university

Minya, Egypt

Location

MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: the study will include two groups. Group I (study group) will be injected PRP. Group II (control group) will be injected methylprednisolone

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 21, 2022
• Study Start: March 10, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 2, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)