Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia
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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
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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 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Plasma |
Biological: Plasma
3 ml plasma injected once into the plantar fascia
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Sham Comparator: Saline |
Biological: Saline
3 ml of saline injected once into the plantar fascia
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Active Comparator: Physiotherapy + heel cap |
Other: Physiotherapy + heel cap
Physiotherapy three times a day for 8 weeks. Heel caps until symptoms are gone
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- Pain on a VAS score
- Disability

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

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
Contact: Bjørn Nedergaard, Cand. Med. | 0045 20204541 | bspn77@gmail.com |
Denmark | |
Sygehus Lillebælt - Kolding Sygehus | Recruiting |
Kolding, Denmark, 6000 | |
Contact: Bjørn Nedergaard, Cand. Med. |
Principal Investigator: | Bjørn Nedergaard, Cand. Med. | Kolding Sygehus |
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 Key Record Dates |
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 |