Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Plasma	Biological: Plasma; 3 ml plasma injected once into the plantar fascia
Sham Comparator: Saline	Biological: 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

Outcome Measures

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Primary Outcome Measures :

1. Pain on a VAS score

Secondary Outcome Measures :

1. Disability

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• between 18 and 70 of age
• Sore at the insertion of the plantar fascia on calcaneus
• A VAS score of at least 4 at the insertion of the plantar fascia on calcaneus taking the first step in the morning
• Symptoms for 6 to 12 months
• Ability to understand danish and give informed consent

Exclusion Criteria:

• Previously operated in the same ankle or foot
• Pain anywhere else in the foot on palpation otherwise than at the insertion of the plantar fascia on calcaneus
• Inflammatory disease
• Diabetes
• Formerly rupture of the Achilles tendon
• Formerly treated with plasma injections
• Ongoing infection treated with antibiotics
• Treated with steroid during the trial
• Treatment of the plantar fasciitis exceeding conservative treatment
• Use of crutches, walker or similar
• Pregnancy

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Bjørn Nedergaard, Cand. Med.	0045 20204541	bspn77@gmail.com

Locations

Denmark
Sygehus Lillebælt - Kolding Sygehus	Recruiting
Kolding, Denmark, 6000
Contact: Bjørn Nedergaard, Cand. Med.

Sponsors and Collaborators

Kolding Sygehus

Investigators

Principal Investigator:	Bjørn Nedergaard, Cand. Med.	Kolding Sygehus

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Bjørn Nedergaard, Cand. Med., Kolding Sygehus
ClinicalTrials.gov Identifier:	NCT01509274 History of Changes
Other Study ID Numbers:	KS6000
First Posted:	January 12, 2012
Last Update Posted:	January 18, 2012
Last Verified:	January 2012

Keywords provided by Bjørn Nedergaard, Kolding Sygehus:

Plantar fasciitis; Plasma; PRP; Heel pain

Additional relevant MeSH terms:

Fasciitis; Fasciitis, Plantar; Musculoskeletal Diseases; Foot Diseases