The Effectiveness of the Combination of PRP and ESWT in Lateral Epicondylitis

NCT05602571 | Completed

• 1 other identifier: LEPRPESWT22
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effectiveness of adding PRP or Sham PRP injection to ESWT treatment in patients with lateral epicondylitis on pain, muscle strength, functional activities, quality of life and work activities, and to determine the superiority of the treatments over each other.

Conditions

Musculoskeletal Diseases; Elbow Tendinitis; Lateral Epicondylitis; Platelet-Rich Plasma (PRP)

Keywords

Lateral Epicondylitis; Extracorporeal Shockwave Therapy (ESWT); Platelet-Rich Plasma (PRP)

Outcome Measures

Primary Outcomes (1)

• Change from baseline visual analog scale (VAS) elbow pain at 4th and 12th week

  Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity. The patient will be asked to score rest, movement, and nighttime pain.

  baseline and 12th week

Secondary Outcomes (5)

• Change from baseline Handgrip strength at 4th and 12th week

  baseline and 12th week

• Change from baseline Quick Disabilities of the Arm, Shoulder and Hand Score (Quick DASH) at 4th and 12th week

  baseline and 12th week

• Change from baseline quality of life (Short Form 36 (SF-36)) at 4th and 12th weeks

  baseline and 12th week

• Change from baseline Ultrasonographic examination at 4th and 12th weeks

  baseline and 12th week

• Change from baseline upper extremity muscle strength with isokinetic device at 4th and 12th weeks

  baseline and 12th week

Study Arms (3)

ESWT+Exercise

EXPERIMENTAL

Home exercise program including stretching and eccentric strengthening exercises twice a day for 3 months + 3 sessions of ESWT once a week for 3 weeks.

Other: ESWT+Exercise

PRP+ESWT+Exercise

ACTIVE COMPARATOR

Home exercise program including stretching and eccentric strengthening exercises twice a day for 3 months + 3 sessions of ESWT once a week for 3 weeks + PRP injection

Procedure: PRP+ESWT+Exercise

Sham PRP+ESWT+Exercise

SHAM COMPARATOR

Home exercise program including stretching and eccentric strengthening exercises twice a day for 3 months + 3 sessions of ESWT once a week for 3 weeks + Sham PRP injection

Procedure: Sham PRP+ESWT+Exercise

Interventions

ESWT+Exercise OTHER

Radial ESWT treatment will be applied to patients for 3 weeks, once a week for a total of 3 sessions. Radial shock waves will be applied in circular motions by applying gel on the epicondylar area where the most pain and sensitivity is. In each session, 8 Hz, 2.0 bar, 2000 beats will be applied. Therapeutic Exercise: All patients will be taught a home exercise program including stretching and eccentric strengthening exercises by an experienced physiotherapist. The eccentric exercises consisted of the following: three sets of 10 repetitions for wrist and elbow flexion; two sets of 10 repetitions for wrist extension strengthening, starting with 50% of maximum strength and density and increasing the resistance each week; and finally, two sets of 10 repetitions for the wrist flexor and extensor muscle groups comprising 20s of stretching and 10s of relaxing using the unaffected hand. Exercise program will be done twice a day for 3 months.

ESWT+Exercise

PRP+ESWT+Exercise PROCEDURE

Radial ESWT treatment will be applied to patients for 3 weeks, once a week for a total of 3 sessions. Radial shock waves will be applied in circular motions by applying gel on the epicondylar area where the most pain and sensitivity is. In each session, 8 Hz, 2.0 bar, 2000 beats will be applied. Therapeutic Exercise: All patients will be taught aforementioned home exercise program. Exercise program will be done twice a day for 3 months. Procedure: 10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged. Approximately 3 cc of the PRP obtained will be applied to the tendinosis area under USG guidance. All injections will be performed with long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe).

PRP+ESWT+Exercise

Sham PRP+ESWT+Exercise PROCEDURE

Radial ESWT treatment will be applied to patients for 3 weeks, once a week for a total of 3 sessions. Radial shock waves will be applied in circular motions by applying gel on the epicondylar area where the most pain and sensitivity is. In each session, 8 Hz, 2.0 bar, 2000 beats will be applied. Therapeutic Exercise: All patients will be taught aforementioned home exercise program. Exercise program will be done twice a day for 3 months. Procedure: In Sham-PRP group,10 ml of venous blood will be taken and after the same waiting time 3 cc of 0.9% saline will be injected to the tendinosis area under USG guidance. All injections will be performed with long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe).

Sham PRP+ESWT+Exercise

Eligibility Criteria

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

You may qualify if:

• Diagnosed with lateral epicondylitis after physical examination
• No other pathology detected on direct radiography
• Complaints persisting for more than 3 months despite the application of other conservative treatment methods
• Patients accepting to give blood for PRP or sham injection and can tolerate elbow injection and extracorporeal shock wave therapy (ESWT)

You may not qualify if:

• Not being able to fully cooperate with the study and inability to read and write,
• Injection (corticosteroid, PRP, etc.) treatment applied to the elbow area within three months,
• Previous surgery or ESWT treatment in the area to be treated,
• Pregnant women,
• Arthritis (rheumatoid arthritis, spondyloarthritis, crystal arthropathies),
• Those who have a history of direct trauma to the elbow and a history of fracture,
• Those with a history of malignancy,
• Bleeding diathesis,
• Complex regional pain syndrome,
• Presence of acute systemic infection,
• Presence of local infection at the injection site,
• Peripheral vasculopathy,
• Cervical radiculopathy,
• Patients with contraindications to ESWT application (pregnancy, cancer, coagulation disorders, inflammatory disease, pacemaker, metal implant in the area to be applied) were excluded from the study.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

Related Publications (4)

• Gunduz R, Malas FU, Borman P, Kocaoglu S, Ozcakar L. Physical therapy, corticosteroid injection, and extracorporeal shock wave treatment in lateral epicondylitis. Clinical and ultrasonographical comparison. Clin Rheumatol. 2012 May;31(5):807-12. doi: 10.1007/s10067-012-1939-y. Epub 2012 Jan 27.

  PMID: 22278162 BACKGROUND

• Alessio-Mazzola M, Repetto I, Biti B, Trentini R, Formica M, Felli L. Autologous US-guided PRP injection versus US-guided focal extracorporeal shock wave therapy for chronic lateral epicondylitis: A minimum of 2-year follow-up retrospective comparative study. J Orthop Surg (Hong Kong). 2018 Jan-Apr;26(1):2309499017749986. doi: 10.1177/2309499017749986.

  PMID: 29320964 BACKGROUND

• Arirachakaran A, Sukthuayat A, Sisayanarane T, Laoratanavoraphong S, Kanchanatawan W, Kongtharvonskul J. Platelet-rich plasma versus autologous blood versus steroid injection in lateral epicondylitis: systematic review and network meta-analysis. J Orthop Traumatol. 2016 Jun;17(2):101-12. doi: 10.1007/s10195-015-0376-5. Epub 2015 Sep 11.

  PMID: 26362783 BACKGROUND

• Akcin AI, Eyvaz N, Dundar U, Toktas H, Yesil H, Eroglu S, Adar S. The Clinical Efficacy of Extracorporeal Shock Wave Therapy Combined With Platelet-Rich Plasma and Exercise for Lateral Epicondylitis: Prospective Randomized Sham-Controlled Ultrasonographic Study. Arch Phys Med Rehabil. 2025 Aug;106(8):1173-1182. doi: 10.1016/j.apmr.2025.01.420. Epub 2025 Jan 20.

  PMID: 39842562 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases; Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Nuran EYVAZ, MD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

• Ali İzzet AKÇİN, MD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator-Research Assistant-MD

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 2, 2022
• Study Start: October 15, 2022
• Primary Completion: December 20, 2023
• Study Completion: January 10, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)