Platelet Rich Plasma Injection Compared With Steroid Injection for the Treatment of Plantar Fasciitis
Condition: Plantar Fasciitis; Steroid; Platelet-rich Plasma (PRP)
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

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.
    

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.
    

Intervention name(s): Platelet Rich Plasma (PRP) group
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): PRP intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A hospital-based randomized clinical trial study will be carried out to compare the efficacy of steroid injection with PRP injection in the treatment for Plantar Fasciitis. Participants will be randomized in a 1:1 ratio, and assigned to steroid injection and PRP injection group through computer generated block randomization.
Masking: None (Open Label)
Primary purpose: Treatment