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

NCT04985396 | Completed DMC

• 1 other identifier: Plantar Fasciitis
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis; Steroid; Platelet-rich Plasma (PRP)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Plantar fascia thickness

  Six months

Study Arms (2)

Platelet Rich Plasma (PRP) group

EXPERIMENTAL

The PRP will be prepared based on the Sengodan et al, 2020 study.

Drug: Platelet Rich Plasma (PRP) group

Steroid group

ACTIVE COMPARATOR

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

Interventions

Platelet Rich Plasma (PRP) group DRUG

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.

Also known as: PRP intervention

Platelet Rich Plasma (PRP) group; Steroid group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Armed Police Force Hospital, Nepal: lead

Study Sites (1)

Dev Ram Sunuwar

Kathmandu, Bagmati, +9779851147339, Nepal

Location

Related Publications (14)

• Lareau CR, Sawyer GA, Wang JH, DiGiovanni CW. Plantar and medial heel pain: diagnosis and management. J Am Acad Orthop Surg. 2014 Jun;22(6):372-80. doi: 10.5435/JAAOS-22-06-372.

  PMID: 24860133 RESULT

• Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.

  PMID: 15152061 RESULT

• League AC. Current concepts review: plantar fasciitis. Foot Ankle Int. 2008 Mar;29(3):358-66. doi: 10.3113/FAI.2008.0358. No abstract available.

  PMID: 18348838 RESULT

• Davis PF, Severud E, Baxter DE. Painful heel syndrome: results of nonoperative treatment. Foot Ankle Int. 1994 Oct;15(10):531-5. doi: 10.1177/107110079401501002.

  PMID: 7834059 RESULT

• Healey K, Chen K. Plantar fasciitis: current diagnostic modalities and treatments. Clin Podiatr Med Surg. 2010 Jul;27(3):369-80. doi: 10.1016/j.cpm.2010.03.002. Epub 2010 May 14.

  PMID: 20691370 RESULT

• Acevedo JI, Beskin JL. Complications of plantar fascia rupture associated with corticosteroid injection. Foot Ankle Int. 1998 Feb;19(2):91-7. doi: 10.1177/107110079801900207.

  PMID: 9498581 RESULT

• David JA, Sankarapandian V, Christopher PR, Chatterjee A, Macaden AS. Injected corticosteroids for treating plantar heel pain in adults. Cochrane Database Syst Rev. 2017 Jun 11;6(6):CD009348. doi: 10.1002/14651858.CD009348.pub2.

  PMID: 28602048 RESULT

• Zhang JY, Fabricant PD, Ishmael CR, Wang JC, Petrigliano FA, Jones KJ. Utilization of Platelet-Rich Plasma for Musculoskeletal Injuries: An Analysis of Current Treatment Trends in the United States. Orthop J Sports Med. 2016 Dec 21;4(12):2325967116676241. doi: 10.1177/2325967116676241. eCollection 2016 Dec.

  PMID: 28210648 RESULT

• Baksh N, Hannon CP, Murawski CD, Smyth NA, Kennedy JG. Platelet-rich plasma in tendon models: a systematic review of basic science literature. Arthroscopy. 2013 Mar;29(3):596-607. doi: 10.1016/j.arthro.2012.10.025. Epub 2013 Jan 24.

  PMID: 23352397 RESULT

• Orchard J. Plantar fasciitis. BMJ. 2012 Oct 10;345:e6603. doi: 10.1136/bmj.e6603. No abstract available.

  PMID: 23054045 RESULT

• Say F, Gurler D, Inkaya E, Bulbul M. Comparison of platelet-rich plasma and steroid injection in the treatment of plantar fasciitis. Acta Orthop Traumatol Turc. 2014;48(6):667-72. doi: 10.3944/AOTT.2014.13.0142.

  PMID: 25637732 RESULT

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 RESULT

• Jain K, Murphy PN, Clough TM. Platelet rich plasma versus corticosteroid injection for plantar fasciitis: A comparative study. Foot (Edinb). 2015 Dec;25(4):235-7. doi: 10.1016/j.foot.2015.08.006. Epub 2015 Aug 22.

  PMID: 26362235 RESULT

• Sharma R, Chaudhary NK, Karki M, Sunuwar DR, Singh DR, Pradhan PMS, Gyawali P, Duwal Shrestha SK, Bhandari KK. Effect of platelet-rich plasma versus steroid injection in plantar fasciitis: a randomized clinical trial. BMC Musculoskelet Disord. 2023 Mar 7;24(1):172. doi: 10.1186/s12891-023-06277-1.

  PMID: 36882804 DERIVED

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Rachit Sharma, MBBS, MS

  Nepal Orthopedic Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 2, 2021
• Study Start: July 25, 2021
• Primary Completion: January 26, 2022
• Study Completion: February 1, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)