Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia
Primary Purpose
Plantar Fasciitis
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Plasma
Saline
Physiotherapy + heel cap
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fasciitis focused on measuring Plantar fasciitis, Plasma, PRP, Heel pain
Eligibility 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
Sites / Locations
- Sygehus Lillebælt - Kolding SygehusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
Plasma
Saline
Physiotherapy + heel cap
Arm Description
Outcomes
Primary Outcome Measures
Pain on a VAS score
Secondary Outcome Measures
Disability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01509274
Brief Title
Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia
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 Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kolding Sygehus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
Plantar fasciitis, Plasma, PRP, Heel pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Plasma
Arm Type
Experimental
Arm Title
Saline
Arm Type
Sham Comparator
Arm Title
Physiotherapy + heel cap
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Plasma
Intervention Description
3 ml plasma injected once into the plantar fascia
Intervention Type
Biological
Intervention Name(s)
Saline
Intervention Description
3 ml of saline injected once into the plantar fascia
Intervention Type
Other
Intervention Name(s)
Physiotherapy + heel cap
Intervention Description
Physiotherapy three times a day for 8 weeks. Heel caps until symptoms are gone
Primary Outcome Measure Information:
Title
Pain on a VAS score
Secondary Outcome Measure Information:
Title
Disability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bjørn Nedergaard, Cand. Med.
Phone
0045 20204541
Email
bspn77@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjørn Nedergaard, Cand. Med.
Organizational Affiliation
Kolding Sygehus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sygehus Lillebælt - Kolding Sygehus
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bjørn Nedergaard, Cand. Med.
12. IPD Sharing Statement
Learn more about this trial
Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia
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