Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia
NCT ID: NCT01509274
Last Updated: 2012-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2011-08-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Plasma
Plasma
3 ml plasma injected once into the plantar fascia
Saline
Saline
3 ml of saline injected once into the plantar fascia
Physiotherapy + heel cap
Physiotherapy + heel cap
Physiotherapy three times a day for 8 weeks. Heel caps until symptoms are gone
Interventions
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Plasma
3 ml plasma injected once into the plantar fascia
Saline
3 ml of saline injected once into the plantar fascia
Physiotherapy + heel cap
Physiotherapy three times a day for 8 weeks. Heel caps until symptoms are gone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Kolding Sygehus
OTHER
Responsible Party
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Bjørn Nedergaard
Cand. Med.
Principal Investigators
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Bjørn Nedergaard, Cand. Med.
Role: PRINCIPAL_INVESTIGATOR
Kolding Sygehus
Locations
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Sygehus Lillebælt - Kolding Sygehus
Kolding, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Bjørn Nedergaard, Cand. Med.
Role: primary
Other Identifiers
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KS6000
Identifier Type: -
Identifier Source: org_study_id
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