Platelet Rich Plasma Injection Compared With Steroid Injection for the Treatment of Plantar Fasciitis

May 16, 2022 updated by: Dev Ram Sunuwar, Armed Police Force Hospital, Nepal

Effect of Platelet Rich Plasma Injection Compared With Steroid Injection for the Treatment of Plantar Fasciitis: A Randomized Clinical Trial

Plantar fasciitis (PF) is the one of the most common orthopaedic problem resulting in heel pain. Previous evidence suggests that Platelet Rich Plasma (PRP) injection has better outcome in the long run as compared to the local steroid injection (SI). Although over the past many years, steroid injection was considered as the choice of treatment after the failure of conservative treatment methods, PRP therapy has shown promising results in the treatment of plantar fasciitis now-a-days. The aim of this study is to assess the effect of PRP injection compared with Steroid injection in the treatment of Plantar Fasciitis.

A hospital-based randomized clinical trial study will be carried out to compare the efficacy of the therapeutic effect between steroid injection and Platelet Rich Plasma injection in plantar fasciitis. A representative sample size of 78 patients aged 18 years to 60 years suffering from plantar fasciitis with failed conservative treatment will be intervened. The American Orthopedic Foot and Ankle Society (AOFAS) and the visual analog scale (VAS) scoring system will be recorded pre- and post-injection phases at 3 months and 6 months period. Statistical analyses will be performed using independent t-test and Mann Whitney U test to compare between the two means. The outcome of this study will help to guide the physicians to choose the better therapeutic approach among the patients suffering from plantar fasciitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Plantar fasciitis is a common and degenerative condition of plantar fascia resulting from excessive strain and micro-trauma on the planter surface of the foot. The prevalence of Plantar Fasciitis is estimated up to 7% in the general population and is common cause of plantar heel pain. The incidence of calcaneum spur with heel pain in the age group of 40 to 50 years is around 59% in the case of India. Plantar fasciitis is defined as localized inflammation and degeneration of the plantar aponeurosis, and it is the most common reason for presentation. Plantar Fasciitis is considered to be a self-limiting disease which resolves, in 80% to 90% of cases, within 10 months. This disease is very problematic for both doctors and patients. The majority of treatment options are non-surgical approaches due to the nature of the disease. The NSAIDS, shoe insert, stretching exercise or extracorporeal shockwave therapy are the common non-surgical therapy. Typically, these types of non-operative treatment are successful up to 90% of the patients with the condition and, in those patients who do not respond to non-operative treatment, injection therapies may be utilized.

The occurrence of plantar fasciitis is multifactorial. The risk factors may be extrinsic or intrinsic. Whatever may be the cause of plantar fasciitis, it is painful and affects the daily functioning of life. Orchard (2012) mentions the lifetime prevalence of plantar fasciitis as 10%, and it mostly affects the people aged 40 to 60 years, having no discrimination in gender. The prevalence of plantar fasciitis is estimated up to 7 % in general population. Goweda et al, 2015 found the prevalence of plantar fasciitis in Saudi Arabia as 57.8%. The number of cases of heel pain is increasing day by in Nepal. The prevalence of Plantar Fasciitis in Nepal could not be traced because of the lack of study in our population. However, different studies have been found in other perspectives. Different modalities of the treatment for PF are available. They are stretching exercise, soft heel pad shoe, ultrasound therapy, NSAIDs etc. If conservative treatment fails, the steroid injection is the preferred choice for the clinicians in practice, but this treatment has certain limitations as it can only reduce pain for a few months but not thereafter. Many studies suggest PRP treatment is more safe and beneficial than steroid injection in this manner. PRP therapy has been gaining popularity over the steroid therapy in the western world. But there are no studies done so far in the context of Nepal. Hence, this study will generate the empirical evidence to fill the knowledge gap for the treatment of PF.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Bagmati
      • Kathmandu, Bagmati, Nepal, +9779851147339
        • Dev Ram Sunuwar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients having the pain over the plantar aspect of foot for more than 6 weeks with tenderness on palpation over the medial calcaneal tuberosity, failure of conservative treatment with physiotherapy, splints and NSAIDs.

Exclusion Criteria:

  • Lumbar radiculopathy
  • Existing trauma, previous surgery or any local pathology over the foot
  • Patient on aspirin
  • Bleeding disorders with low platelet counts
  • Systemic disease like diabetes and rheumatoid arthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet Rich Plasma (PRP) group
The PRP will be prepared based on the Sengodan et al, 2020 study.
Drug: Platelet Rich Plasma (PRP) group
Platelet Rich Plasma (PRP) group will be intervened with PRP injection. The collection of 30 ml blood of patients into acid citrate dextrose tube under aseptic condition will be done and subjected for centrifugation at 2000 rpm (soft spin) through digital centrifuge machine speed control (REMI, R-8C PLUS). There will be three layers of blood, among them the supernatant layer and buff coat of plasma will be again subjected to centrifuge at 3000 rpm (hard spin). The upper two thirds of the tube containing platelet poor plasma will be discarded and finally, the lower one third concentrated platelet plasma superficial buffy coat will be injected into medial calcaneal tuberosity at the most tender point.
Other Names:
  • PRP intervention
Active Comparator: Steroid group

Steroid group will be treated with steroid injection. In this group, 2ml of Inj. Depo-Medrol 80 mg (Methylprednisolone) along with 1 ml lignocaine (0.25%) will be loaded in 5cc syringe and then the cocktail will be injected into medial calcaneal tuberosity at the most tender point using an aseptic technique as mentioned by Nishanth et.at,2018.

After the procedure, participants will be advised not to involve in any kind of rigorous activity with the affected foot for at least two days and then gradually return to their regular activities. All patients will be counseled to follow up in the next visit at 3 months and 6 months. The end-line information will be again recorded at 3 months and 6 months.
Drug: Platelet Rich Plasma (PRP) group
Platelet Rich Plasma (PRP) group will be intervened with PRP injection. The collection of 30 ml blood of patients into acid citrate dextrose tube under aseptic condition will be done and subjected for centrifugation at 2000 rpm (soft spin) through digital centrifuge machine speed control (REMI, R-8C PLUS). There will be three layers of blood, among them the supernatant layer and buff coat of plasma will be again subjected to centrifuge at 3000 rpm (hard spin). The upper two thirds of the tube containing platelet poor plasma will be discarded and finally, the lower one third concentrated platelet plasma superficial buffy coat will be injected into medial calcaneal tuberosity at the most tender point.
Other Names:
  • PRP intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction
Time Frame: Six months
Visual analog scale (VAS) will be used to measure the pain assessment at the three months and six months follow-up.
Six months
Functional mobility of the patients
Time Frame: Six months
American Foot and Ankle Score (AFAS) ankle-Hindfoot scale will be used to measure the functional outcome of the patients at the three months and six months follow-up.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plantar fascia thickness
Time Frame: Six months
Measure the changes of plantar fascia thickness in steroid injection and Platelet-Rich Plasma injection using ultrasonogram at six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Police Force Hospital, Nepal

Investigators

  • Study Director: Rachit Sharma, MBBS, MS, Nepal Orthopedic Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2021

Primary Completion (Actual)

January 26, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

August 2, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • plantar fasciitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Plantar Fasciitis

Clinical Trials on Platelet Rich Plasma (PRP) group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe