Back to resultsPlatelet Rich Plasma in Plantar Fasciitis (PRP)
Primary Purpose
Plantar Fascitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
platelet rich plasma
MethylPREDNISolone 40 MG
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fascitis focused on measuring degenerative plantar fasciitis, platelet rich plasma, ultrasound guided injection, heel pain, interventional rheumatology
Eligibility Criteria
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
Sites / Locations
- Minya university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Platelet rich plasma group
Methylprednisolone group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
visual analogue scale
visual analogue scale from 0-10, where 0 denoting maximum pain relief and 10 denoting no pain relief
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)
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05339542
Brief Title
Platelet Rich Plasma in Plantar Fasciitis
Acronym
PRP
Official Title
Musculoskeletal Ultrasound Changes in the Plantar Fascia After a Single Injection of Platelet Rich Plasma Compared to Steroid
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis
Keywords
degenerative plantar fasciitis, platelet rich plasma, ultrasound guided injection, heel pain, interventional rheumatology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet rich plasma group
Arm Type
Experimental
Arm Description
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.
Arm Title
Methylprednisolone group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
platelet rich plasma
Intervention Description
derived from patient own blood
Intervention Type
Drug
Intervention Name(s)
MethylPREDNISolone 40 MG
Other Intervention Name(s)
1 ml Lidocaine 2%
Intervention Description
active comparative intervention
Primary Outcome Measure Information:
Title
visual analogue scale
Description
visual analogue scale from 0-10, where 0 denoting maximum pain relief and 10 denoting no pain relief
Time Frame
3 months
Title
Manchester-Oxford Foot Questionnaire
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
echogenicity in longitudinal scan gray scale ultrasound
Description
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
Time Frame
3 months
Title
plantar fascia thickness at the insertion in longitudinal scan of the heel
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Minya university
City
Minya
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Platelet Rich Plasma in Plantar Fasciitis
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