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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 because the information has not been verified recently.
Verified January 2012 by Kolding Sygehus.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Bjørn Nedergaard, Kolding Sygehus
ClinicalTrials.gov Identifier:
NCT01509274
First received: January 10, 2012
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: January 10, 2012
Last Updated: January 16, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Kolding Sygehus:
Plantar fasciitis
Plasma
PRP
Heel pain

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases

ClinicalTrials.gov processed this record on September 23, 2016