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. 2014 Apr 29;2014(4):CD010071. doi: 10.1002/14651858.CD010071.pub3

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: NCT01509274Date 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