Clinical Trials Directory

Trials / Unknown

UnknownNCT03938896

PRP IN Planter Fascitis

The Effectiveness of Platelet Rich Plasma in Treatment of Chronic Planter Fasciitis

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Mansoura University · Academic / Other
Sex
All
Age
25 Years – 60 Years
Healthy volunteers
Not accepted

Summary

The present study was carried out on fifty patients with chronicunilateral PF. Patients were recruited from Outpatient Clinic of Physical medicine, Rheumatology and Rehabilitation at Mansoura University Hospital during the period from January 2016 to September 2016. Patients were classifiedrandomly into two groups:the 1stgroup included 25 patients (20 females and 5 males) treated by local corticosteroid injectionand the 2ndgroup included 25 patients (20 females and 5males) treated by PRP injection. We obtain an informed written consent from each participant sharing in the study. We take approval on our study by the research board of faculty of medicine, Mansoura University, code: MS/15.10.08. :

Detailed description

The present study was carried out on fifty patients with chronicunilateral PF. Patients were recruited from Outpatient Clinic of Physical medicine, Rheumatology and Rehabilitation at Mansoura University Hospital during the period from January 2016 to September 2016. Patients were classifiedrandomly into two groups:the 1stgroup included 25 patients (20 females and 5 males) treated by local corticosteroid injectionand the 2ndgroup included 25 patients (20 females and 5males) treated by PRP injection. We obtain an informed written consent from each participant sharing in the study. We take approval on our study by the research board of faculty of medicine, Mansoura University, code: MS/15.10.08. All patients were subjected to the following: 1- Complete history taking: a. Personal history: with special stress on: i. Age and sex. ii. Occupation: occupation which needs prolonged standing is a risk factor for PF. b. Complaint: Taken in the patient's own words with special stress on disease duration. c. Present history: i. Pain as regard onset, course, duration, provocative factors, relieving factors, limitation of movement and diurnal variation. ii. History of arthritis and joint affection. iii. History of other systems affections: * Neurological symptoms: (muscle power and sensation of the lower limbs). * Eye symptoms: (redness, ulcers and blurred vision). * Gastrointestinal tract (GIT) symptoms: (diarrhea, heart burn and mucus in the stool). * Urinary tract (UT) symptoms: (dysuria and frequency). * Skin affection: (ulcers, erythema, papules and nodules). b. Locomotor system examination: * Of all joints with special stress on the ankle, subtalar andmidtarsal joint including: i. Inspection: swelling, deformity and muscle wasting. ii. Palpation: hotness, tenderness. iii. Range of motion: active and passive. * Clinical examination of the heel: * Inspection of any obvious deformities (pesplanus, pescavus and hallux valgus) and skin changes (redness and swelling). 1. corticosteroid injection: Patients were put in the supine position. Injection was done usingthe medial technique. Identification of the tenderest point of the heel was done by palpation. Antiseptic solution was used to disinfect the skin overlying theheel. Then1ml of 40 mg methylprednisolone acetate and 1 ml of local anaesthetic as lidocaine 2% were injected into the plantar fascia by a 22gauge needle. After injection, participants were advised to stay sitting without foot movement for 15 minutes (Khan et al., 2014). 2. PRP injection: It started with puncture of the vein and taking specific amount of autologous blood from the participantnearly a sample of 20 ml of venous blood (Co AY, 2012).The blood sample was put in a sterile tube containing an anticoagulant as sodium citrate.Then the blood sample wascentrifuged for 15 minutes at 1800 rpmwhich leads to separation of the plasma at the top layer from the packed RBCs at the bottom layer. The RBCs layer is removedthenanother centrifugationwas done at 3500 rpm for 10 minuteswhich leads to formation of a more concentratedplatelet layer after removal of PPP(Anitua et al., 2012). Patients were put in supine position. Betadine was used to disinfect the skin of the heel. 1 ml of local anesthesitic (lidocaine) was injected;then, by the same syringe, 2.5 ml of PRP was injected in the tenderestarea.After extraction of the needle, a bandage was puton the injected area. The patient was kept in the supine position for twentyminutes and then discharged (Say et al., 2014). Somepatients may have minimal to moderate discomfort afterinjection that may continue for 7 days because PRP stimulates an inflammatory response. So, to control pain, patients shouldapply ice on the heeland also modify activity as tolerated

Conditions

Interventions

TypeNameDescription
OTHERplatelet rich plasmaPatients were put in supine position. Betadine was used to disinfect the skin of the heel. 1 ml of local anesthesitic (lidocaine) was injected;then, by the same syringe, 2.5 ml of PRP was injected in the tenderestarea.After extraction of the needle, a bandage was puton the injected area. The patient was kept in the supine position for twentyminutes and then discharged
OTHERcorticosteroidPatients were put in the supine position. Injection was done usingthe medial technique. Identification of the tenderest point of the heel was done by palpation. Antiseptic solution was used to disinfect the skin overlying theheel. Then1ml of 40 mg methylprednisolone acetate and 1 ml of local anaesthetic as lidocaine 2% were injected into the plantar fascia by a 22gauge needle. After injection, participants were advised to stay sitting without foot movement for 15 minutes

Timeline

Start date
2017-10-01
Primary completion
2019-07-01
Completion
2020-01-01
First posted
2019-05-06
Last updated
2019-08-14

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03938896. Inclusion in this directory is not an endorsement.

PRP IN Planter Fascitis (NCT03938896) · Clinical Trials Directory