Clincosm LogoSign in Get a demo

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

Sponsor
Istanbul Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05240872
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
22.5
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: PRP injection
  • Biological: ABI injection
 Phase 3

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

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Oct 30, 2020
Actual Study Completion Date :
Jan 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A

Platelet Rich Plasm (PRP) injection group

Biological: PRP injection
Plantar fascia injection therapy with PRP
Active Comparator: Group B

Autologous Blood injection (ABI) group

Biological: ABI injection
ABI injection

Outcome Measures

Primary Outcome Measures

  1. Changes in Visual Analogue Scale (VAS) [0,1 st 3rd and 6th month; changes between time points will be assessed]

    Visual Analogue Scale 10 worst 0-1 best in terms of pain outcome

  2. Changes in American Orthopaedic Foot & Ankle Society (AOFAS ) Score [0,1 st 3rd and 6th month; changes between time points will be assessed]

    American Orthopaedic Foot & Ankle Society (AOFAS) Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes Evaluation:0 worst 100 best

  3. Changes in Foot and Ankle Disability Index (FADI) [0,1 st 3rd and 6th month; changes between time points will be assessed]

    Foot and Ankle Disability Index Evaluation:0 worst 100 best

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

  1. Patients with systemic disorder like diabetes mellitus, ankylosing spondylitis rheumatoid arthritis, hematological disease, or gout

  2. Pregnancy

  3. Use of antiocoagulation -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Atasehir Florence Nightingale Hospital Ataşehir Istanbul Turkey 34750

Sponsors and Collaborators

  • Istanbul Training and Research Hospital

Investigators

  • Principal Investigator: Celalettin Bildik, MD, Istanbul Atasehir Florence Nightingale Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ozcan Kaya, Orthopaedics and Traumatology Specialist, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05240872
Other Study ID Numbers:
  • 13.02.2020/008
First Posted:
Feb 15, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ozcan Kaya, Orthopaedics and Traumatology Specialist, Istanbul Training and Research Hospital
heel pain, platelet rich plasm, autologous blood injection
Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar

Study Results

No Results Posted as of Mar 2, 2022