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

Plantar Fasciitis Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis
• Platelet-rich Plasma (PRP)
• Steroid

• NCT number: NCT04985396
• Study type: Interventional
• Source: Armed Police Force Hospital, Nepal
• Status: Completed
• Phase: N/A
• Start date: July 25, 2021
• Completion date: February 1, 2022