Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Completed NCT02546115 - RCT - Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis N/A
Terminated NCT01996111 - Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis N/A
Unknown status NCT01882894 - Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment N/A
Completed NCT01659827 - Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis N/A
Completed NCT00758641 - Platelet Rich Plasma to Treat Plantar Fasciitis Phase 4
Completed NCT00888394 - Effectiveness of Podiatry on Plantar Pain Phase 4
Terminated NCT00527748 - Foot and Ankle Range of Motion (Stretching) Apparatus N/A
Recruiting NCT05584046 - A Single-blind RCT to Investigate the Effect of a Novel Herbal Patch for the Treatment of PF N/A
Completed NCT04088383 - Amnios™ RT Outcomes Study N/A
Completed NCT01994759 - Optimal Treatment of Plantar Fasciitis: Physical Training, Glucocorticoid Injections or a Combination Thereof. Phase 4
Completed NCT02646579 - Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only N/A
Completed NCT05592808 - Comparison of Taping Techniques in Plantar Fasciitis N/A
Not yet recruiting NCT04125264 - Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis N/A
Completed NCT02546089 - ABI v Dry Needling for Plantar Fasciitis N/A
Completed NCT00765843 - A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain N/A
Completed NCT00155324 - Change and Clinical Significance of Plantar Fascia Thickness After ESWT N/A
Completed NCT04941469 - Effectiveness of Specifically Optimized Off-the-counter Foot Orthosis for the Subtle Cavus Foot N/A
Completed NCT06055933 - Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Plantar Fasciitis
Recruiting NCT02539082 - the Safety and Efficacy of Collagen Injection in Patients With Plantar Fasciitis Phase 4
Enrolling by invitation NCT01786057 - Effect of Extracorporeal Shock Wave Therapy of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis Phase 2/Phase 3