The Effectiveness of Platelet Rich Plasma in Treatment of Chronic Planter Fasciitis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Mansoura University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- change of pain from base line
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
platelet rich plasma
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.
Intervention: platelet rich plasma (Other)
corticosteroid
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.
Intervention: corticosteroid (Other)
Outcomes
Primary Outcomes
change of pain from base line
Time Frame: immediately before injection,1 month after injection,3 monthes after injection,6 monthes after injection
VAS is a one-dimensionalmethod used largely in adult patients who also haverheumatic diseases for measuring pain intensity.The VAS score is composed of a continuous linewhich may be a horizontal (HVAS) or vertical (VVAS) line. This line is usually 10 cm (100 mm) in length. To measure the intensity of pain, the score is anchored by "no pain" (0 score) and "pain is as bad as it could be" or "worst imaginable pain"(100 score)on the 100 mm scale. The patient can complete the VAS score by himself. The patientplaces a perpendicular line to the VAS line at the point whichrepresents the intensity of his pain.We can usea ruler to determine the score by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a score range from 0 to 100. According tothe measurement of VAS score in postsurgical
Secondary Outcomes
- change from base linePlantar fasciitis pain and disability scale (PFPS(immediately before injection,1 month after injection,3 monthes after injection,6 monthes after injection)
- change from base lineThe modified criteria of the Roles and Maudsley score(immediately before injection,1 month after injection,3 monthes after injection,6 monthes after injection)