PRP: Platelet Rich Plasma in Plantar Fasciitis

Sponsor

Minia University (Other)

Overall Status

Completed

CT.gov ID

NCT05339542

Collaborator

(none)

Enrollment

Location

Arms

3.7

Actual Duration (Months)

26.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Plantar Fascitis	Other: platelet rich plasma Drug: MethylPREDNISolone 40 MG	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 10, 2022

Actual Primary Completion Date :

Jul 1, 2022

Actual Study Completion Date :

Jul 2, 2022

Arms and Interventions

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%

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%

Outcome Measures

Primary Outcome Measures

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

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