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

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ClinicalTrials.gov Identifier: NCT04985396
Recruitment Status : Not yet recruiting
First Posted : August 2, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Dev Ram Sunuwar, Armed Police Force Hospital, Nepal

Brief 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.


Condition or disease Intervention/treatment Phase
Plantar Fasciitis Steroid Platelet-rich Plasma (PRP) Drug: Platelet Rich Plasma (PRP) group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
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
Official Title: Effect of Platelet Rich Plasma Injection Compared With Steroid Injection for the Treatment of Plantar Fasciitis: A Randomized Clinical Trial
Estimated Study Start Date : July 25, 2021
Estimated Primary Completion Date : January 26, 2022
Estimated Study Completion Date : February 1, 2022

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 Name: 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 Name: PRP intervention




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04985396


Contacts
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Contact: Dev Ram Sunuwar, M.Sc +9779851147339 devramsunuwar@gmail.com
Contact: Narendra Kumar Chaudhary, M.Sc +9779841321219 narenchem@yahoo.com

Locations
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Nepal
Dev Ram Sunuwar
Kathmandu, Bagmati, Nepal, +9779851147339
Contact: Dev Ram Sunuwar, M.Sc    +977-9851147339    devramsunuwar@gmail.com   
Contact: Narendra Kumar Chaudhary, M.Sc    +977-9841321219    narenchem@yahoo.com   
Sponsors and Collaborators
Armed Police Force Hospital, Nepal
Investigators
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Study Director: Rachit Sharma, MBBS, MS Nepal Orthopedic Hospital
Publications of Results:

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Responsible Party: Dev Ram Sunuwar, Assistant Professor, Armed Police Force Hospital, Nepal
ClinicalTrials.gov Identifier: NCT04985396    
Other Study ID Numbers: Plantar Fasciitis
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases