Clinical trial NCT03938896: PRP IN Planter Fascitis
Official title: The Effectiveness of Platelet Rich Plasma in Treatment of Chronic Planter Fasciitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Plantar Fasciitis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

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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

Eligibility criteria: Inclusion Criteria:

* The study included fifty patients with chronic unilateral PF who were diagnosed by history and physical examination.Patients have heel pain (with VAS more than 50 mm) and tightness after waking upin the morning or after sitting for longperiod. Heel pain will typically improve with movement but maybe increasedatthe end of the day with continuouswalking or standing for a long period.On examining the patients,to avoid placing pressure on the painful heel, patients may walk with their affected foot in an equine position. Palpation of the medial plantar calcaneal region will cause a sharp stabbing pain. Passive ankle/first toe dorsiflexion can cause discomfort in the proxi¬mal plantar fascia(Goff and Crawford, 2011).

Exclusion Criteria:

* Patients with the following conditions were excluded:
* Patients with bilateral heel pain.
* Patients who had received previous local steroid injection.
* Patients who had received NSAIDs within one week.
* Patients having anemia with hemoglobin below 10 gm%, bleeding dyscrasias or thrombocytopenia.
* Patients having earlier injury or surgery to the sole.
* Patients having calcaneal stress fracture, Achilles tendinopathy, tarsal tunnel syndrome or seronegativespondyloarthropathy.
* Patients havingpsychiatric disorders.
* Patients having metabolic or endocrine disease.
* Patients with arthritis of the foot.
* Patients having infections, tumours, vascular abnormalities or neuropathy.
* Patients with hepatic

Primary outcomes:
measure: change of pain from base line
timeFrame: immediately before injection,1 month after injection,3 monthes after injection,6 monthes after injection
Secondary outcomes:
measure: change from base linePlantar fasciitis pain and disability scale (PFPS
timeFrame: immediately before injection,1 month after injection,3 monthes after injection,6 monthes after injection
measure: change from base lineThe modified criteria of the Roles and Maudsley score
timeFrame: immediately before injection,1 month after injection,3 monthes after injection,6 monthes after injection
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Reham Magdy Shaat
state: Dakahlia Provence
Study officials:
References: