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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04985396
Other study ID # Plantar Fasciitis
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 25, 2021
Est. completion date February 1, 2022

Study information

Verified date May 2022
Source Armed Police Force Hospital, Nepal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


Description:

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Study Design


Intervention

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.

Locations

Country Name City State
Nepal Dev Ram Sunuwar Kathmandu Bagmati

Sponsors (1)

Lead Sponsor Collaborator
Armed Police Force Hospital, Nepal

Country where clinical trial is conducted

Nepal, 

References & Publications (13)

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Outcome

Type Measure Description Time frame Safety issue
Primary Pain reduction Visual analog scale (VAS) will be used to measure the pain assessment at the three months and six months follow-up. Six months
Primary Functional mobility of the patients 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 Plantar fascia thickness Measure the changes of plantar fascia thickness in steroid injection and Platelet-Rich Plasma injection using ultrasonogram at six months Six months
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