NCT01509274.
Trial name or title | Treatment of plantar fasciitis with injection of platelet rich plasma Into the origin of the plantar fascia: a prospective, randomised and double blinded study |
Methods | Study design: randomised trial Random sequence generation: not reported Allocation concealment: not reported Masking: double blind (subject, investigator, outcome assessor) |
Participants | Location: Target sample size (N): 90 participants Inclusion criteria: 18‐70 years of age; pain 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 6‐12 months; ability to understand Danish and give informed consent Exclusion criteria: previously operated on in the same ankle or foot; pain in the foot anywhere other than the insertion of the plantar fascia on calcaneus on palpation; inflammatory disease; diabetes; previous rupture of the Achilles tendon; previous treatment with plasma injections; ongoing infection treated with antibiotics; treatment with steroids during the trial; treatment of the plantar fasciitis exceeding conservative treatment; use of crutches, walker or similar; pregnancy |
Interventions |
PRP: plasma (3 mL plasma injected once into the plantar fascia) Controls or placebo or no intervention (standard care): 2 arms ‐ saline (3 mL saline injected once into the plantar fascia) and physiotherapy (3 times a day for 8 weeks) plus heel cap |
Outcomes |
Primary outcomes: pain (VAS score)
Secondary outcomes: not provided Timing of outcomes measurement: at inclusion and after 1, 2, 3, 6 and 12 months |
Starting date |
Main ID: NCT01509274
Date of registration: 10 January 2012 Last refreshed on: 16 January 2012 Date of first enrolment: August 2011 Status: recruiting participants |
Contact information | Name: Bjørn Nedergaard Address: not provided Telephone: not provided Email: bspn77@gmail.com Affiliation: Kolding Sygehus |
Notes |