Clinical trial NCT05240872: Effects of Autologous Blood Injection Versus Platelet Rich Plasma on Chronic Plantar Fasciitis
Official title: Is There Any Advantage of PRP Over Autologous Blood Injection in the Treatment of Chronic Plantar Fasciitis? A Prospective Randomized Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plantar Fascitis
Keywords: heel pain, platelet rich plasm, autologous blood injection
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore effects of Autologous Blood Injection versus Platelet Rich plasma injection for treatment of chronic plantar fasciitis

Detailed description: After clinical diagnosis of patients with plantar fasciitis. Patients were divided into two groups. Group A (PRP injection group) and Group B (ABI group) were randomized according to web based block group randomization. Patients were evaluated prior to injection in terms of Health related quality of life scores related to foot and ankle diseases (AOFAS and FADI) and VAS. After injection at 1st, 3rd and 6th months HRQoL were compared between groups. Intra group evaluation for HRQoL were performed at f/up visits. Independent t test and repeated measure ANOVA test used for statistical analysis

Eligibility criteria: Inclusion Criteria:

1. Participants who were diagnosed with chronic plantar fasciitis
2. Nonresponded to o conservative treatment (stretching exercises, nonsteroidal anti-inflammatory drugs, and heel pads) for at least 6 weeks
3. Patient should be able to understand the informed consent about type of treatment and blindness and randomization
4. Visual analog scale pain higher than 5 (on a 10-point visual analog scale)

Exclusion Criteria:

1. previous history of any type of local injection treatment for heel pain
2. history of surgery for heel pain, foot and ankle disorders, fractures
3. Associated pathology involving the lower limb such as

   * tarsal tunnel syndrome
   * effusion of the ankle indicating an intra-articular disease
   * Peroneal/Achilles/tibialis tendons pathology
   * any obvious deformity of foot and ankle,
4. Patients with systemic disorder like diabetes mellitus, ankylosing spondylitis rheumatoid arthritis, hematological disease, or gout
5. Pregnancy
6. Use of antiocoagulation -

Primary outcomes:
measure: Changes in Visual Analogue Scale (VAS)
timeFrame: 0,1 st 3rd and 6th month; changes between time points will be assessed
measure: Changes in American Orthopaedic Foot & Ankle Society (AOFAS ) Score
timeFrame: 0,1 st 3rd and 6th month; changes between time points will be assessed
measure: Changes in Foot and Ankle Disability Index (FADI)
timeFrame: 0,1 st 3rd and 6th month; changes between time points will be assessed
Secondary outcomes:
Other outcomes:
Locations:
city: Ataşehir
country: Turkey
facility: Atasehir Florence Nightingale Hospital
state: Istanbul
Study officials:
affiliation: Istanbul Atasehir Florence Nightingale Hospital
name: Celalettin Bildik, MD
role: PRINCIPAL_INVESTIGATOR
References:
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