None listed
Conditions
Brief summary
This study aims to compare the efficacy of ultrasound guided intralesional injection of autologous platelet rich plasma (PRP) with corticosteroid injection for plantar fasciitis present for more than six weeks that has failed to settle symptomatically with conservative management.
Interventions
Three intra-fascial PRP injections (2 mL PRP each) guided by ultrasound, by a medial approach following injection of local anaesthetic into the skin, and at weekly intervals.
Three mL of platelet rich plasma will be obtained using a single step centrifugation procedure and XC-2000 laboratory benchtop centrifuge. Twenty five point five mL of autologous blood will be divided equally between three 8.5 mL ACD BD Vacutainer venous blood collection tubes and centrifuged at 2,000 rpm (447 g) for 10 min
Three intra-fascial PRP injections (2 mL PRP each) guided by ultrasound, by a medial approach following injection of local anaesthetic into the skin, and at weekly intervals. Three mL of platelet rich plasma will be obtained using a single step centrifugation procedure and XC-2000 laboratory benchtop centrifuge. Twenty five point five mL of autologous blood will be divided equally between three 8.5 mL ACD BD Vacutainer venous blood collection tubes and centrifuged at 2,000 rpm (447 g) for 10 minutes. The lowest 1 mL of the plasma, the platelet rich plasma (PRP), is then harvested from each tube avoiding contamination by the buffy coat and red cell layers. Two mL will be collected for injection into the patient and 1 mL will be collected for laboratory analysis of platelet numbers. Each sample will be ‘activated’ with 0.05 mL calcium chloride 10% per 1 mL plasma.
Sponsors
Dr. William Craddock
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. presenting complaint of plantar heel pain worse on rising in the morning and/or after periods of sitting or lying, which have been present for longer than 6 weeks 2. on examination, site of maximal tenderness at the attachment of the plantar fascia on the medial tubercle of the calcaneus 3. plantar fascial thickness > 4 mm at the area of maximal tenderness 4. failed conservative management of at least 4 weeks duration consisting of calf stretching, tibialis posterior and flexor hallucis longus strengthening, and the use of an off-the-shelf orthotic with heel cut-out and plantar fascial groove
Exclusion criteria
1. previous injections or surgery for heel pain 2. nerve-related symptoms 3. regional pain syndrome 4. achilles tendon pathology 5. rheumatoid arthritis 6. spondyloarthropathy (incl. ankylosing spondylitis, reactive arthritis, enteropathic arthritis, and psoriatic arthritis) 7. diabetes mellitus 8. local infection 9. peripheral vascular disease 10. gout 11. coagulopathy or anti-coagulant therapy 12. pregnancy 13. dysfunction of the knee, ankle, or foot 14. work-related or compensable injury
Outcome results
None listed