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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2012 by Bjørn Nedergaard, Kolding Sygehus.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01509274

First Posted: January 12, 2012

Last Update Posted: January 18, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Bjørn Nedergaard, Kolding Sygehus

Purpose

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	Intervention	Phase
Plantar Fasciitis	Biological: Plasma Biological: Saline Other: Physiotherapy + heel cap	Phase 4


Study Type:	Interventional
Study Design:	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.

Further study details as provided by Bjørn Nedergaard, Kolding Sygehus:

Primary Outcome Measures:

Pain on a VAS score

Secondary Outcome Measures:

Disability


Estimated Enrollment:	90
Study Start Date:	August 2011
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509274

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


Responsible Party:	Bjørn Nedergaard, Cand. Med., Kolding Sygehus
ClinicalTrials.gov Identifier:	NCT01509274 History of Changes
Other Study ID Numbers:	KS6000
First Submitted:	January 10, 2012
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

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