Leukocyte-Poor Platelet-Rich Plasma Reduces Pain Symptoms in the Treatment of the Lateral Epicondylitis

NCT06854666 | Completed

• 2 other identifiers: RSC_JWAL_2024_V1Secec grant 2017
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral epicondylar tendinopathy (LET), or tennis elbow, is a degenerative condition affecting the forearm's extensor tendons. It commonly leads to pain, reduced grip strength, and impaired function, particularly in individuals performing repetitive wrist and forearm movements. Standard treatments, including physiotherapy, braces, and anti-inflammatory medications, provide relief but do not always lead to full recovery. Platelet-rich plasma (PRP) has gained interest as a regenerative therapy with the potential to enhance tendon healing and improve clinical outcomes. This randomized, double-blind, placebo-controlled trial aims to evaluate PRP's effectiveness in treating LET, comparing it to leukocyte-rich PRP (L-PRP) and saline (placebo). Additionally, it assesses the composition of PRP and its role in tendon regeneration. The study will enroll 80 patients diagnosed with LET, meeting predefined clinical criteria. Participants will be randomized into three groups (PRP, L-PRP, saline) and receive two injections (day 0 and day 7). PRP will be prepared using a standardized protocol to ensure consistency. Patients will undergo clinical evaluations (VAS, Mayo Elbow Score, SECEC Elbow Score), grip strength testing, and MRI scans at baseline and 24 weeks post-treatment. The PRP composition will be analyzed in a laboratory. Follow-ups will be conducted at 12, 24, and 54 weeks to monitor pain reduction, functional improvement, and tendon healing. This study will provide critical insights into PRP's therapeutic potential, helping refine treatment approaches for LET and improve patient outcomes.

Conditions

Tennis Elbow; Lateral Epicondylitis; Lateral Epicondylitis (tennis Elbow); PRP Injection; PRP and Physiotherapy

Keywords

tennis elbow; prp

Outcome Measures

Primary Outcomes (3)

• Improvement in Pain (VAS Score)

  Description: This study aims to evaluate whether PRP reduces pain in patients with lateral epicondylar tendinopathy (LET). Assessment Tool: Visual Analog Scale (VAS) Scale: 0 to 10 (0 = no pain, 10 = worst possible pain) Higher scores indicate worse pain outcomes. Time Frame: 12 months

  12 months

• Grip Strength

  Grip Strength: The study includes grip strength testing with isometric grip strenght measure BTE, which is a primary measure of functional improvement following treatment.

  12 months

• Improvement in Functional Outcomes (Oxford Elbow Score - OES)

  Description: This study will assess whether PRP improves elbow function and daily activity performance in LET patients. Assessment Tool: Oxford Elbow Score (OES) Scale: 0 to 48 (0 = worst function/pain, 48 = best function/pain) Higher scores indicate better functional outcomes.

  12 months

Other Outcomes (1)

• Healing Process of Tendons

  12 months

Study Arms (3)

Standardized PRP Injection

ACTIVE COMPARATOR

A standardized PRP preparation protocol (without commercial kits) is used, ensuring consistency in platelet concentration. Preparation Process: Blood Collection: 30 ml of venous blood drawn from each patient Centrifugation: 7 minutes at 2,054 g using MPV-223e centrifuge Separation: Blood fractionated into erythrocytes, leukocytes, PRP, and platelet-poor plasma PRP Isolation: Pure PRP extracted for injection Injection Procedure: 2 ml of PRP injected into the tendon pain area, with 1 ml retained for laboratory analysis

Other: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)

Standardized leukocyte-rich PRP (L-PRP)

ACTIVE COMPARATOR

A standardized leukocyte-rich PRP (L-PRP) preparation protocol (without commercial kits) is used to ensure consistency in platelet and leukocyte concentrations. Preparation Process: Blood Collection: 30 ml of venous blood drawn from each patient Centrifugation: 7 minutes at 2,054 g using MPV-223e centrifuge Separation: Blood fractionated into erythrocytes, leukocytes, PRP, and platelet-poor plasma L-PRP Isolation: Leukocyte-rich PRP extracted for injection Injection Procedure: 2 ml of L-PRP injected into the tendon pain area, with 1 ml retained for laboratory analysis

Other: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)

Saline Injection (Placebo Control)

ACTIVE COMPARATOR

A placebo control group receiving a standardized saline injection to evaluate the efficacy of PRP and L-PRP treatments. Procedure: Injection of 2 ml of sterile saline into the tendon pain area, following the same protocol as the PRP and L-PRP groups.

Other: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)

Interventions

effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET) OTHER

The intervention involves the administration of PRP (platelet-rich plasma), L-PRP (leukocyte-rich platelet-rich plasma), and saline according to a protocol developed for patients with lateral epicondylitis (EPi lat). The intervention includes specific parameters such as centrifugation speed and dual injection to the painful site, which is repeated after one week. Following the procedure, treatment continues with a rehabilitation program, including the use of an orthosis. The orthosis serves as support during the recovery process after the injection. The rehabilitation program and the use of the orthosis aim to improve joint function and reduce pain, supporting tissue healing and regeneration.

Saline Injection (Placebo Control); Standardized PRP Injection; Standardized leukocyte-rich PRP (L-PRP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first-time diagnosis of chronic lateral epicondylitis with a duration of at least 1 month, age of 18 years or more, and signed informed consent to participate in the study

You may not qualify if:

• pregnancy, any previous treatment for the condition (including injections around the elbow, rehabilitation, or use of orthoses), previous surgical treatment of the elbow, other painful elbow conditions, co-existing upper limb and/or neck pain, prior elbow trauma or arthritic changes, posterior interosseous nerve (PIN) neuropathy, and systemic disorders

Sponsors & Collaborators

• Rehasport Clinic: lead

Study Sites (1)

Rehasport

Poznan, Wielkopolska, Poland

Location

Related Publications (17)

• Kushida S, Kakudo N, Morimoto N, Hara T, Ogawa T, Mitsui T, Kusumoto K. Platelet and growth factor concentrations in activated platelet-rich plasma: a comparison of seven commercial separation systems. J Artif Organs. 2014 Jun;17(2):186-92. doi: 10.1007/s10047-014-0761-5. Epub 2014 Apr 20.

  PMID: 24748436 BACKGROUND

• Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009 Mar;27(3):158-67. doi: 10.1016/j.tibtech.2008.11.009. Epub 2009 Jan 31.

  PMID: 19187989 BACKGROUND

• Chaudhury S, de La Lama M, Adler RS, Gulotta LV, Skonieczki B, Chang A, Moley P, Cordasco F, Hannafin J, Fealy S. Platelet-rich plasma for the treatment of lateral epicondylitis: sonographic assessment of tendon morphology and vascularity (pilot study). Skeletal Radiol. 2013 Jan;42(1):91-7. doi: 10.1007/s00256-012-1518-y. Epub 2012 Sep 22.

  PMID: 23001116 BACKGROUND

• Fulginiti VA. A new pertussis vaccine: hope for the future? J Infect Dis. 1983 Jul;148(1):146-7. doi: 10.1093/infdis/148.1.146. No abstract available.

  PMID: 6350485 BACKGROUND

• Palacio EP, Schiavetti RR, Kanematsu M, Ikeda TM, Mizobuchi RR, Galbiatti JA. Effects of platelet-rich plasma on lateral epicondylitis of the elbow: prospective randomized controlled trial. Rev Bras Ortop. 2016 Jan 13;51(1):90-5. doi: 10.1016/j.rboe.2015.03.014. eCollection 2016 Jan-Feb.

  PMID: 26962506 BACKGROUND

• Dronamraju KR. The origins of human gene mapping. With particular reference to the contributions of J. B. S. Haldane. Genomics. 1987 Nov;1(3):270-6. doi: 10.1016/0888-7543(87)90054-1.

  PMID: 3328738 BACKGROUND

• Yadav R, Kothari SY, Borah D. Comparison of Local Injection of Platelet Rich Plasma and Corticosteroids in the Treatment of Lateral Epicondylitis of Humerus. J Clin Diagn Res. 2015 Jul;9(7):RC05-7. doi: 10.7860/JCDR/2015/14087.6213. Epub 2015 Jul 1.

  PMID: 26393174 BACKGROUND

• Gautam VK, Verma S, Batra S, Bhatnagar N, Arora S. Platelet-rich plasma versus corticosteroid injection for recalcitrant lateral epicondylitis: clinical and ultrasonographic evaluation. J Orthop Surg (Hong Kong). 2015 Apr;23(1):1-5. doi: 10.1177/230949901502300101.

  PMID: 25920633 BACKGROUND

• Italiano JE Jr, Richardson JL, Patel-Hett S, Battinelli E, Zaslavsky A, Short S, Ryeom S, Folkman J, Klement GL. Angiogenesis is regulated by a novel mechanism: pro- and antiangiogenic proteins are organized into separate platelet alpha granules and differentially released. Blood. 2008 Feb 1;111(3):1227-33. doi: 10.1182/blood-2007-09-113837. Epub 2007 Oct 25.

  PMID: 17962514 BACKGROUND

• El-Sharkawy H, Kantarci A, Deady J, Hasturk H, Liu H, Alshahat M, Van Dyke TE. Platelet-rich plasma: growth factors and pro- and anti-inflammatory properties. J Periodontol. 2007 Apr;78(4):661-9. doi: 10.1902/jop.2007.060302.

  PMID: 17397313 BACKGROUND

• Cieslik-Bielecka A, Gazdzik TS, Bielecki TM, Cieslik T. Why the platelet-rich gel has antimicrobial activity? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Mar;103(3):303-5; author reply 305-6. doi: 10.1016/j.tripleo.2006.08.034. Epub 2007 Jan 2. No abstract available.

  PMID: 17197209 BACKGROUND

• Filardo G, Kon E, Di Matteo B, Di Martino A, Tesei G, Pelotti P, Cenacchi A, Marcacci M. Platelet-rich plasma injections for the treatment of refractory Achilles tendinopathy: results at 4 years. Blood Transfus. 2014 Oct;12(4):533-40. doi: 10.2450/2014.0289-13. Epub 2014 Jun 19.

  PMID: 24960641 BACKGROUND

• Dohan Ehrenfest DM, Andia I, Zumstein MA, Zhang CQ, Pinto NR, Bielecki T. Classification of platelet concentrates (Platelet-Rich Plasma-PRP, Platelet-Rich Fibrin-PRF) for topical and infiltrative use in orthopedic and sports medicine: current consensus, clinical implications and perspectives. Muscles Ligaments Tendons J. 2014 May 8;4(1):3-9. eCollection 2014 Jan.

  PMID: 24932440 BACKGROUND

• 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 BACKGROUND

• Mazzocca AD, McCarthy MB, Chowaniec DM, Dugdale EM, Hansen D, Cote MP, Bradley JP, Romeo AA, Arciero RA, Beitzel K. The positive effects of different platelet-rich plasma methods on human muscle, bone, and tendon cells. Am J Sports Med. 2012 Aug;40(8):1742-9. doi: 10.1177/0363546512452713. Epub 2012 Jul 16.

  PMID: 22802273 BACKGROUND

• Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.

  PMID: 21422467 BACKGROUND

• Walecka J, Bakowski P, Jokiel M, Trabka R, Chaszczewska-Markowska M, Ghete D, Gurda-Wozna D, Fedoruk-Wyszomirska A, Lubiatowski P, Wyszko E, Tyczewska A, Bakowska-Zywicka K. Molecular background behind lateral elbow pain reduction with Leukocyte-Rich and Leukocyte-Poor Platelet-Rich Plasma-randomized control trial and single-cell platelet analysis. Int Orthop. 2026 Jan 24. doi: 10.1007/s00264-025-06719-6. Online ahead of print.

  PMID: 41579194 DERIVED

MeSH Terms

Conditions

Tennis Elbow; Insomnia, Fatal Familial

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Prion Diseases; Central Nervous System Infections; Infections; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Joanna Walecka, MD, PhD

  Rehasport Clinic

  PRINCIPAL INVESTIGATOR

• Przemyslaw Lubiatowski, MD, Phd,

  Rehasport Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: March 3, 2025
• Study Start: January 2, 2017
• Primary Completion: February 10, 2024
• Study Completion: March 10, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)