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

January 16, 2012 updated by: Bjørn Nedergaard, Kolding Sygehus

Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia - a Prospective, Randomized and Double Blinded Study.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bjørn Nedergaard, Cand. Med.
  • Phone Number: 0045 20204541
  • Email: bspn77@gmail.com

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain on a VAS score

Secondary Outcome Measures

Outcome Measure
Disability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kolding Sygehus

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2012

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (ESTIMATE)

January 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 16, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS6000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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