Effects of Autologous Blood Injection Versus Platelet Rich Plasma on Chronic Plantar Fasciitis

Plantar Fascitis Clinical Trial

— PF:AutovsPRP  

Official title:

Is There Any Advantage of PRP Over Autologous Blood Injection in the Treatment of Chronic Plantar Fasciitis? A Prospective Randomized Double Blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05240872
• Other study ID #: 13.02.2020/008
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2020
• Est. completion date: January 15, 2022

Study information

• Verified date: February 2022
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore effects of Autologous Blood Injection versus Platelet Rich plasma injection for treatment of chronic plantar fasciitis

Description:

After clinical diagnosis of patients with plantar fasciitis. Patients were divided into two groups. Group A (PRP injection group) and Group B (ABI group) were randomized according to web based block group randomization. Patients were evaluated prior to injection in terms of Health related quality of life scores related to foot and ankle diseases (AOFAS and FADI) and VAS. After injection at 1st, 3rd and 6th months HRQoL were compared between groups. Intra group evaluation for HRQoL were performed at f/up visits. Independent t test and repeated measure ANOVA test used for statistical analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 15, 2022
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Participants who were diagnosed with chronic plantar fasciitis

2. Nonresponded to o conservative treatment (stretching exercises, nonsteroidal anti-inflammatory drugs, and heel pads) for at least 6 weeks

3. Patient should be able to understand the informed consent about type of treatment and blindness and randomization

4. Visual analog scale pain higher than 5 (on a 10-point visual analog scale)

Exclusion Criteria:

1. previous history of any type of local injection treatment for heel pain

2. history of surgery for heel pain, foot and ankle disorders, fractures

3. Associated pathology involving the lower limb such as

• tarsal tunnel syndrome

• effusion of the ankle indicating an intra-articular disease

• Peroneal/Achilles/tibialis tendons pathology

• any obvious deformity of foot and ankle,

4. Patients with systemic disorder like diabetes mellitus, ankylosing spondylitis rheumatoid arthritis, hematological disease, or gout

5. Pregnancy

6. Use of antiocoagulation -

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

Biological:
• PRP injection
Plantar fascia injection therapy with PRP
• ABI injection
ABI injection

Locations

Country	Name	City	State
Turkey	Atasehir Florence Nightingale Hospital	Atasehir	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (26)

Arnoczky SP, Sheibani-Rad S. The basic science of platelet-rich plasma (PRP): what clinicians need to know. Sports Med Arthrosc Rev. 2013 Dec;21(4):180-5. doi: 10.1097/JSA.0b013e3182999712. Review. Erratum in: Sports Med Arthrosc. 2014 Jun;22(2):150. Shebani-Rad, Shahin [corrected to Sheibani-Rad, Shahin]. — View Citation

Bagcier F, Yilmaz N. The Impact of Extracorporeal Shock Wave Therapy and Dry Needling Combination on Pain and Functionality in the Patients Diagnosed with Plantar Fasciitis. J Foot Ankle Surg. 2020 Jul - Aug;59(4):689-693. doi: 10.1053/j.jfas.2019.09.038. Epub 2020 Apr 25. — View Citation

Crawford F, Atkins D, Young P, Edwards J. Steroid injection for heel pain: evidence of short-term effectiveness. A randomized controlled trial. Rheumatology (Oxford). 1999 Oct;38(10):974-7. — View Citation

Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma: from basic science to clinical applications. Am J Sports Med. 2009 Nov;37(11):2259-72. doi: 10.1177/0363546509349921. Review. — View Citation

Gupta R, Malhotra A, Masih GD, Khanna T, Kaur H, Gupta P, Kashyap S. Comparing the Role of Different Treatment Modalities for Plantar Fasciitis: A Double Blind Randomized Controlled Trial. Indian J Orthop. 2020 Jan 20;54(1):31-37. doi: 10.1007/s43465-019-00038-w. eCollection 2020 Feb. — View Citation

Hall MP, Band PA, Meislin RJ, Jazrawi LM, Cardone DA. Platelet-rich plasma: current concepts and application in sports medicine. J Am Acad Orthop Surg. 2009 Oct;17(10):602-8. Review. Erratum in: J Am Acad Orthop Surg. 2010 Jan;18(1):17A. — View Citation

Jain SK, Suprashant K, Kumar S, Yadav A, Kearns SR. Comparison of Plantar Fasciitis Injected With Platelet-Rich Plasma vs Corticosteroids. Foot Ankle Int. 2018 Jul;39(7):780-786. doi: 10.1177/1071100718762406. Epub 2018 Mar 30. — View Citation

Kalia RB, Singh V, Chowdhury N, Jain A, Singh SK, Das L. Role of Platelet Rich Plasma in Chronic Plantar Fasciitis: A Prospective Study. Indian J Orthop. 2020 Oct 6;55(Suppl 1):142-148. doi: 10.1007/s43465-020-00261-w. eCollection 2021 May. — View Citation

Karimzadeh A, Raeissadat SA, Erfani Fam S, Sedighipour L, Babaei-Ghazani A. Autologous whole blood versus corticosteroid local injection in treatment of plantar fasciitis: A randomized, controlled multicenter clinical trial. Clin Rheumatol. 2017 Mar;36(3):661-669. doi: 10.1007/s10067-016-3484-6. Epub 2016 Dec 12. — View Citation

Kaya O, Hurel C, Gumussuyu G, Kose O. Bilateral calcaneal insufficiency fractures due to chronic carbamazepine use for trigeminal neuralgia: A case report. Niger J Clin Pract. 2020 Apr;23(4):574-576. doi: 10.4103/njcp.njcp_515_18. — View Citation

Landorf KB. Plantar heel pain and plantar fasciitis. BMJ Clin Evid. 2015 Nov 25;2015. pii: 1111. — View Citation

Latt LD, Jaffe DE, Tang Y, Taljanovic MS. Evaluation and Treatment of Chronic Plantar Fasciitis. Foot Ankle Orthop. 2020 Feb 13;5(1):2473011419896763. doi: 10.1177/2473011419896763. eCollection 2020 Jan. Review. — View Citation

Lee TG, Ahmad TS. Intralesional autologous blood injection compared to corticosteroid injection for treatment of chronic plantar fasciitis. A prospective, randomized, controlled trial. Foot Ankle Int. 2007 Sep;28(9):984-90. — View Citation

Mahindra P, Yamin M, Selhi HS, Singla S, Soni A. Chronic Plantar Fasciitis: Effect of Platelet-Rich Plasma, Corticosteroid, and Placebo. Orthopedics. 2016 Mar-Apr;39(2):e285-9. doi: 10.3928/01477447-20160222-01. Epub 2016 Feb 25. — View Citation

Martin JE, Hosch JC, Goforth WP, Murff RT, Lynch DM, Odom RD. Mechanical treatment of plantar fasciitis. A prospective study. J Am Podiatr Med Assoc. 2001 Feb;91(2):55-62. — View Citation

Martinelli N, Marinozzi A, Carnì S, Trovato U, Bianchi A, Denaro V. Platelet-rich plasma injections for chronic plantar fasciitis. Int Orthop. 2013 May;37(5):839-42. doi: 10.1007/s00264-012-1741-0. Epub 2012 Dec 19. — View Citation

Ragab EM, Othman AM. Platelets rich plasma for treatment of chronic plantar fasciitis. Arch Orthop Trauma Surg. 2012 Aug;132(8):1065-70. doi: 10.1007/s00402-012-1505-8. Epub 2012 May 4. — View Citation

Shetty SH, Dhond A, Arora M, Deore S. Platelet-Rich Plasma Has Better Long-Term Results Than Corticosteroids or Placebo for Chronic Plantar Fasciitis: Randomized Control Trial. J Foot Ankle Surg. 2019 Jan;58(1):42-46. doi: 10.1053/j.jfas.2018.07.006. Epub 2018 Nov 15. — View Citation

Singh P, Madanipour S, Bhamra JS, Gill I. A systematic review and meta-analysis of platelet-rich plasma versus corticosteroid injections for plantar fasciopathy. Int Orthop. 2017 Jun;41(6):1169-1181. doi: 10.1007/s00264-017-3470-x. Epub 2017 Apr 10. Review. — View Citation

Stuber K, Kristmanson K. Conservative therapy for plantar fasciitis: a narrative review of randomized controlled trials. J Can Chiropr Assoc. 2006 Jun;50(2):118-33. — View Citation

Tatli YZ, Kapasi S. The real risks of steroid injection for plantar fasciitis, with a review of conservative therapies. Curr Rev Musculoskelet Med. 2009 Mar;2(1):3-9. doi: 10.1007/s12178-008-9036-1. Epub 2008 Sep 19. — View Citation

Thomas JL, Christensen JC, Kravitz SR, Mendicino RW, Schuberth JM, Vanore JV, Weil LS Sr, Zlotoff HJ, Bouché R, Baker J; American College of Foot and Ankle Surgeons heel pain committee. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg. 2010 May-Jun;49(3 Suppl):S1-19. doi: 10.1053/j.jfas.2010.01.001. Review. — View Citation

Tsai WC, Hsu CC, Chen CP, Chen MJ, Yu TY, Chen YJ. Plantar fasciitis treated with local steroid injection: comparison between sonographic and palpation guidance. J Clin Ultrasound. 2006 Jan;34(1):12-6. — View Citation

Tsikopoulos K, Tsikopoulos A, Natsis K. Autologous whole blood or corticosteroid injections for the treatment of epicondylopathy and plantar fasciopathy? A systematic review and meta-analysis of randomized controlled trials. Phys Ther Sport. 2016 Nov;22:114-122. doi: 10.1016/j.ptsp.2016.02.002. Epub 2016 Feb 24. Review. — View Citation

Wheeler PC, Dudson C. Similar Benefits Seen After Radial Extracorporeal Shockwave Therapy or Autologous Blood Injection in Patients With Chronic Plantar Fasciitis-A Retrospective Cohort Study. Clin J Sport Med. 2021 Jul 7. doi: 10.1097/JSM.0000000000000930. [Epub ahead of print] — View Citation

Yu T, Xia J, Li B, Zhou H, Yang Y, Yu G. Outcomes of platelet-rich plasma for plantar fasciopathy: a best-evidence synthesis. J Orthop Surg Res. 2020 Sep 21;15(1):432. doi: 10.1186/s13018-020-01783-7. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Visual Analogue Scale (VAS)	Visual Analogue Scale 10 worst 0-1 best in terms of pain outcome	0,1 st 3rd and 6th month; changes between time points will be assessed
Primary	Changes in American Orthopaedic Foot & Ankle Society (AOFAS ) Score	American Orthopaedic Foot & Ankle Society (AOFAS) Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes Evaluation:0 worst 100 best	0,1 st 3rd and 6th month; changes between time points will be assessed
Primary	Changes in Foot and Ankle Disability Index (FADI)	Foot and Ankle Disability Index Evaluation:0 worst 100 best	0,1 st 3rd and 6th month; changes between time points will be assessed