Tennis ElbowLETNCT06854666
Leukocyte-Poor Platelet-Rich Plasma Reduces Pain Symptoms in the Treatment of the Lateral Epicondylitis
A study testing effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET) in people with Tennis Elbow and Lateral Epicondylitis, run by Rehasport Clinic at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tennis Elbow, Lateral Epicondylitis, Lateral Epicondylitis (tennis Elbow)
- What is being tested?
- effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jan 2017to 10 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Morphological Evaluation Following Treatment of Lateral Epicondylar Tendinopathy with PRP or L-PRP,saline- Prospective Randomized Double Blinded Controlled Trial
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.
Read more
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.
Read the detailed description
Detailed Description
Study Rationale
Lateral epicondylar tendinopathy (LET), commonly referred to as tennis elbow, is a chronic degenerative condition affecting the common extensor tendon (CET) at the lateral epicondyle of the humerus. It is commonly observed in individuals engaged in repetitive wrist and forearm movements, such as athletes, manual laborers, and office workers. The primary pathological mechanism involves microtears leading to pain, reduced grip strength, and impaired function.
Conservative treatments, including physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and bracing, often provide temporary symptom relief but do not facilitate tendon regeneration. Corticosteroid injections may offer short-term pain relief but have been associated with tendon degeneration and higher recurrence rates. Given the limitations of these treatments, platelet-rich plasma (PRP) has emerged as a promising biological therapy due to its high concentration of growth factors that promote tissue healing, angiogenesis, and anti-inflammatory effects.
However, the optimal formulation of PRP remains controversial. Some studies suggest that leukocyte-rich PRP (L-PRP) may enhance the inflammatory response and accelerate healing, while others indicate that leukocyte-poor PRP (LP-PRP) may have superior effects by reducing excessive inflammation. The cellular composition of PRP is not standardized across clinical studies, leading to variability in treatment outcomes. This study seeks to clarify the role of PRP in LET treatment, determine whether L-PRP offers superior benefits, and evaluate its effects on pain relief, functional recovery, and tendon healing over time.
Study Design and Methodology
This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy of PRP and L-PRP, saline compared to saline injections in treating LET. The study will enroll 80 symptomatic patients diagnosed with LET based on clinical criteria. Patients will be randomly assigned to one of the three treatment groups:
PRP Group (n=20): Standard platelet-rich plasma injection
L-PRP Group (n=20): Leukocyte-rich platelet-rich plasma injection
Saline Group (Control) (n=20): Placebo (saline) injection
Both PRP and L-PRP will be prepared using a standardized, non-commercial protocol to ensure consistency in cellular composition. Blinding procedures will ensure that neither the patients nor the evaluating clinicians know which treatment is administered.
Patient Selection Criteria
Inclusion Criteria:
Age 18-65 years
Diagnosed with chronic lateral epicondylitis (duration >6 months)
Positive clinical tests: pain on resisted wrist extension and decreased grip strength
Written informed consent
Exclusion Criteria:
Previous elbow surgery or PRP treatment
Corticosteroid injections within the past 3 months
Systemic inflammatory or autoimmune diseases
Pregnancy or breastfeeding
Neurological conditions affecting upper limb function
PIN syndrome
Treatment Protocol
Pre-Treatment Evaluation:
All patients will undergo:
Clinical assessment of pain and function
VAS and Oxford Elbow Score questionnaires
Grip strength testing using BTE
MRI imaging of the affected elbow (baseline)
Injection Procedure:
Blood Collection: 30 ml of venous blood will be drawn from each patient
Centrifugation: Blood will be centrifuged at 2054 g for 7 minutes to separate PRP fractions
PRP/L-PRP Preparation: The appropriate PRP fraction will be extracted (with or without leukocytes)
Injection: 2 ml of PRP or L-PRP will be injected into the CET, with 1 ml retained for laboratory analysis
Control Group: Patients will receive an equivalent saline injection following the same procedure
Post-Treatment Rehabilitation:
Guided physiotherapy program focusing on eccentric strengthening
Use of elbow braces during daily activities
Activity modification guidelines
Outcome Measures and Follow-Up
Primary Outcome:
Pain reduction measured by VAS score
Secondary Outcomes:
Functional improvement assessed using Oxford Elbow Score
Grip strength recovery using a digital dynamometer BTE Structural tendon healing assessed via MRI at baseline and 24 weeks post-treatment
Follow-Up Schedule:
Week 0: Baseline assessments and first injection
Week 1: Second injection
Week 12: First follow-up visit (VAS, Oxford Elbow Score, grip strength)
Week 24: Second follow-up visit (MRI assessment, VAS, Oxford Elbow Score, grip strength)
Week 54: Final follow-up visit (long-term clinical evaluation, VAS, Oxford Elbow Score, grip strength)
Laboratory Analysis
PRP samples will be analyzed for platelet concentration, leukocyte content, and growth factor levels
Comparative analysis between PRP and L-PRP to correlate biological composition with clinical outcomes
Expected Impact and Clinical Relevance
This study aims to establish a standardized PRP protocol for LET treatment and determine whether PRP offers superior benefits compared to conventional approaches. The results will provide:
High-quality evidence for clinicians regarding PRP effectiveness
Guidance on PRP formulation (leukocyte-rich vs. leukocyte-poor)
Objective MRI data to track structural healing of the common extensor tendon
Improved treatment strategies to enhance patient recovery and reduce recurrence rates
By correlating PRP composition with clinical and imaging outcomes, this trial will help refine biologic treatment strategies for chronic tendinopathies, ultimately improving evidence-based management of LET.
- Conditions
- Tennis Elbow, Lateral Epicondylitis, Lateral Epicondylitis (tennis Elbow), PRP Injection, PRP and Physiotherapy
- Being tested
- effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)
- Keywords
- tennis elbow, prp
- Medical subject headings
- Tennis Elbow, Insomnia, Fatal Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Other: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start2 Jan 2017
- Primary completion10 Feb 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehasport Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna Walecka, MD, PhD, Principal investigator, Rehasport ClinicPrzemyslaw Lubiatowski, MD, Phd,, Study director, Rehasport Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854666
- Sponsor's protocol ID
- RSC_JWAL_2024_V1
- Other IDs
- Secec grant 2017
- Acronym
- LET
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24748436Dohan 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.
PubMed 19187989Chaudhury 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.
PubMed 23001116Fulginiti 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.
PubMed 6350485Palacio 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.
PubMed 26962506Dronamraju 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.
PubMed 3328738Yadav 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.
PubMed 26393174Gautam 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.
PubMed 25920633Italiano 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.
PubMed 17962514El-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.
PubMed 17397313Cieslik-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.
PubMed 17197209Filardo 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.
PubMed 24960641Dohan 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.
PubMed 24932440Baksh 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.
PubMed 23352397Mazzocca 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.
PubMed 22802273
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Morphological Evaluation Following Treatment of Lateral Epicondylar Tendinopathy with PRP or L-PRP,saline- Prospective Randomized Double Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT06854666
- Acronym / sponsor ID
- LET / RSC_JWAL_2024_V1
- Conditions
- Tennis Elbow, Lateral Epicondylitis, Lateral Epicondylitis (tennis Elbow), PRP Injection, PRP and Physiotherapy
- Keywords
- tennis elbow, prp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Rehasport ClinicUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed Description
Study Rationale
Lateral epicondylar tendinopathy (LET), commonly referred to as tennis elbow, is a chronic degenerative condition affecting the common extensor tendon (CET) at the lateral epicondyle of the humerus. It is commonly observed in individuals engaged in repetitive wrist and forearm movements, such as athletes, manual laborers, and office workers. The primary pathological mechanism involves microtears leading to pain, reduced grip strength, and impaired function.
Conservative treatments, including physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and bracing, often provide temporary symptom relief but do not facilitate tendon regeneration. Corticosteroid injections may offer short-term pain relief but have been associated with tendon degeneration and higher recurrence rates. Given the limitations of these treatments, platelet-rich plasma (PRP) has emerged as a promising biological therapy due to its high concentration of growth factors that promote tissue healing, angiogenesis, and anti-inflammatory effects.
However, the optimal formulation of PRP remains controversial. Some studies suggest that leukocyte-rich PRP (L-PRP) may enhance the inflammatory response and accelerate healing, while others indicate that leukocyte-poor PRP (LP-PRP) may have superior effects by reducing excessive inflammation. The cellular composition of PRP is not standardized across clinical studies, leading to variability in treatment outcomes. This study seeks to clarify the role of PRP in LET treatment, determine whether L-PRP offers superior benefits, and evaluate its effects on pain relief, functional recovery, and tendon healing over time.
Study Design and Methodology
This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy of PRP and L-PRP, saline compared to saline injections in treating LET. The study will enroll 80 symptomatic patients diagnosed with LET based on clinical criteria. Patients will be randomly assigned to one of the three treatment groups:
PRP Group (n=20): Standard platelet-rich plasma injection
L-PRP Group (n=20): Leukocyte-rich platelet-rich plasma injection
Saline Group (Control) (n=20): Placebo (saline) injection
Both PRP and L-PRP will be prepared using a standardized, non-commercial protocol to ensure consistency in cellular composition. Blinding procedures will ensure that neither the patients nor the evaluating clinicians know which treatment is administered.
Patient Selection Criteria
Inclusion Criteria:
Age 18-65 years
Diagnosed with chronic lateral epicondylitis (duration >6 months)
Positive clinical tests: pain on resisted wrist extension and decreased grip strength
Written informed consent
Exclusion Criteria:
Previous elbow surgery or PRP treatment
Corticosteroid injections within the past 3 months
Systemic inflammatory or autoimmune diseases
Pregnancy or breastfeeding
Neurological conditions affecting upper limb function
PIN syndrome
Treatment Protocol
Pre-Treatment Evaluation:
All patients will undergo:
Clinical assessment of pain and function
VAS and Oxford Elbow Score questionnaires
Grip strength testing using BTE
MRI imaging of the affected elbow (baseline)
Injection Procedure:
Blood Collection: 30 ml of venous blood will be drawn from each patient
Centrifugation: Blood will be centrifuged at 2054 g for 7 minutes to separate PRP fractions
PRP/L-PRP Preparation: The appropriate PRP fraction will be extracted (with or without leukocytes)
Injection: 2 ml of PRP or L-PRP will be injected into the CET, with 1 ml retained for laboratory analysis
Control Group: Patients will receive an equivalent saline injection following the same procedure
Post-Treatment Rehabilitation:
Guided physiotherapy program focusing on eccentric strengthening
Use of elbow braces during daily activities
Activity modification guidelines
Outcome Measures and Follow-Up
Primary Outcome:
Pain reduction measured by VAS score
Secondary Outcomes:
Functional improvement assessed using Oxford Elbow Score
Grip strength recovery using a digital dynamometer BTE Structural tendon healing assessed via MRI at baseline and 24 weeks post-treatment
Follow-Up Schedule:
Week 0: Baseline assessments and first injection
Week 1: Second injection
Week 12: First follow-up visit (VAS, Oxford Elbow Score, grip strength)
Week 24: Second follow-up visit (MRI assessment, VAS, Oxford Elbow Score, grip strength)
Week 54: Final follow-up visit (long-term clinical evaluation, VAS, Oxford Elbow Score, grip strength)
Laboratory Analysis
PRP samples will be analyzed for platelet concentration, leukocyte content, and growth factor levels
Comparative analysis between PRP and L-PRP to correlate biological composition with clinical outcomes
Expected Impact and Clinical Relevance
This study aims to establish a standardized PRP protocol for LET treatment and determine whether PRP offers superior benefits compared to conventional approaches. The results will provide:
High-quality evidence for clinicians regarding PRP effectiveness
Guidance on PRP formulation (leukocyte-rich vs. leukocyte-poor)
Objective MRI data to track structural healing of the common extensor tendon
Improved treatment strategies to enhance patient recovery and reduce recurrence rates
By correlating PRP composition with clinical and imaging outcomes, this trial will help refine biologic treatment strategies for chronic tendinopathies, ultimately improving evidence-based management of LET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standardized PRP Injection | Active comparator | Other: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)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 |
| Standardized leukocyte-rich PRP (L-PRP) | Active comparator | Other: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)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 |
| Saline Injection (Placebo Control) | Active comparator | Other: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)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. | Other | Saline Injection (Placebo Control), Standardized PRP Injection, Standardized leukocyte-rich PRP (L-PRP) |
Primary outcome
Improvement in Pain (VAS Score)
Time frame: 12 months
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
Grip Strength
Time frame: 12 months
Grip Strength: The study includes grip strength testing with isometric grip strenght measure BTE, which is a primary measure of functional improvement following treatment.
Improvement in Functional Outcomes (Oxford Elbow Score - OES)
Time frame: 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Background: PubMed 24748436Kushida 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.
- Background: PubMed 19187989Dohan 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.
- Background: PubMed 23001116Chaudhury 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.
- Background: PubMed 6350485Fulginiti 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.
- Background: PubMed 26962506Palacio 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.
- Background: PubMed 3328738Dronamraju 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.
- Background: PubMed 26393174Yadav 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.
- Background: PubMed 25920633Gautam 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.
- Background: PubMed 17962514Italiano 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.
- Background: PubMed 17397313El-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.
- Background: PubMed 17197209Cieslik-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.
- Background: PubMed 24960641Filardo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Walecka, MD, PhD principal investigator
Rehasport Clinic
Przemyslaw Lubiatowski, MD, Phd, study director
Rehasport Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET) in people with Tennis Elbow and Lateral Epicondylitis, run by Rehasport Clinic at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Pain (VAS Score) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06854666, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.