Patients with plantar fasciitis
Conditions
Interventions
Trade Name: Kenakort
Product Name: Corticosteroid
Product Code: Depomedrol met lidiocaine
Pharmaceutical Form: Suspension for injection
Sponsors
Biomet Nederland BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • No bias to sex • > 18 years • Chronic plantar fasciitis or proximal recalcitrant plantar heel pain (6-12 months duration) • Failed conservative treatment • Able to understand the informed consent • VAS pain by starting up higher as 5 (0-10 scale) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Received local steroid injections within 6 weeks, physical/occupational therapies within 4 weeks, or non-steroidal anti-inflammatory within 1 week prior to randomization • Inability to fulfil follow-up criteria • Significant cardiovascular, renal or hepatic disease • Pregnant • (Local) malignancy • History of amenia (hemoglobin < 5.0 ) • Previous surgery for plantar fasciitis • Active bilateral plantar fasciitis • Diagnosis of vascular insufficiency or neuropathy related to heel pain • Hypothyroidism • Diabetics • No other painful or function limited disorders of the foot and ankle
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Does injection with autologous platelet concentrate results in a larger percentage of successful treated patients after 6 month as injection corticosteroid injection?;Secondary Objective: • Does injection with autologous platelet concentrate has a larger pain reduction as injection of corticosteroid injection? • Does injection with autologous platelet concentrate has a larger improvement in function as corticosteroid injection? • Does injection with autologous platelet concentrate has a larger amount of satisfied patients as of corticosteroid injection? ;Primary end point(s): Pain | — |
Countries
Netherlands
Outcome results
None listed