Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia
|ClinicalTrials.gov Identifier: NCT01509274|
Recruitment Status : Unknown
Verified January 2012 by Bjørn Nedergaard, Kolding Sygehus.
Recruitment status was: Recruiting
First Posted : January 12, 2012
Last Update Posted : January 18, 2012
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
|Condition or disease||Intervention/treatment||Phase|
|Plantar Fasciitis||Biological: Plasma Biological: Saline Other: Physiotherapy + heel cap||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||June 2012|
3 ml plasma injected once into the plantar fascia
|Sham Comparator: Saline||
3 ml of saline injected once into the plantar fascia
|Active Comparator: Physiotherapy + heel cap||
Other: Physiotherapy + heel cap
Physiotherapy three times a day for 8 weeks. Heel caps until symptoms are gone
- Pain on a VAS score
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509274
|Contact: Bjørn Nedergaard, Cand. Med.||0045 firstname.lastname@example.org|
|Sygehus Lillebælt - Kolding Sygehus||Recruiting|
|Kolding, Denmark, 6000|
|Contact: Bjørn Nedergaard, Cand. Med.|
|Principal Investigator:||Bjørn Nedergaard, Cand. Med.||Kolding Sygehus|