Plantar Fasciitis Clinical Trial
Official title:
Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia - a Prospective, Randomized and Double Blinded Study.
The purpose of our study is to determine whether one injection with plasma into the origin
of the plantar fascia is an effective treatment of plantar fasciitis.
90 patients will be randomized into three groups. 30 patients will be treated with one
plasma injection, 30 patients will be treated with one injection with saline and 30 patients
will do physiotherapy and use heel cups. The two groups who receive injections will do the
same physiotherapy and use heel cups, as the conservatively treated group.
Both groups randomized to receive an injection will have a 10 ml blood sample taken from
their cubital vein. The sample is centrifuged for 5 minutes at 5000 rpm. No additives are
added. 3 ml of plasma i obtained, and the syringe i blinded. Is the patient randomized to
receive an injection with saline, a similar syringe is blinded with 3 ml of saline. The
injection into to the origin of the plantar fascia i done 10 minutes after the sample of
blood is obtained. The content of the syringe i blinded to both the investigator and the
patient.
The injection i performed from the medial aspect of the heel under guidance of ultrasound.
No local/systemic analgetic is used. The content of the syringe is spread using peppering
technique into the origin of the plantar fascia.
Patients will do questionnaires at inclusion and after 1, 2, 3, 6 and 12 months. The
questionaires will be Foot Function Index and SF-36 as well as questions about their use of
analgetics, use of heel cups and intensity of their physiotherapy
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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