Effects of Autologous Blood Injection Versus Platelet Rich Plasma on Chronic Plantar Fasciitis (PF:AutovsPRP)

Istanbul Training and Research Hospital

Status and phase: Completed; Phase 3

Conditions: Plantar Fascitis

Treatments: Biological: PRP injection; Biological: ABI injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05240872

13.02.2020/008

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Group A

Active Comparator group

Description:

Platelet Rich Plasm (PRP) injection group

Treatment:

Biological: PRP injection

Group B

Active Comparator group

Description:

Autologous Blood injection (ABI) group

Treatment:

Biological: ABI injection