Clinical trial NCT05602571: The Effectiveness of the Combination of PRP and ESWT in Lateral Epicondylitis
Official title: Effects of Adding Platelet-Rich Plasma (PRP) Therapy to Extracorporeal Shock Wave Therapy (ESWT) in Patients With Lateral Epicondylitis: Double-Blind Randomized Sham-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Elbow Tendinitis
Lateral Epicondylitis
Platelet-Rich Plasma (PRP)
Keywords: Lateral Epicondylitis
Extracorporeal Shockwave Therapy (ESWT)
Platelet-Rich Plasma (PRP)
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Lateral epicondylitis (LE) is one of the most common elbow problems. It is characterized by pain in the lateral epicondyle of the humerus and on the surface of the extensor muscles of the forearm. It is seen in those who perform activities involving repetitive forced wrist extension and can lead to chronic pain syndrome.

Various treatment methods are used in the treatment of LE in order to reduce the patient's pain and increase his/her functional capacity. There are more than 40 treatment methods in the literature such as oral and local non-steroidal anti-inflammatory drugs (NSAID), cold application, deep friction massage, stretching and strengthening exercises, ultrasound, laser, ESWT, corticosteroid/botulinum toxin/glucosamine/autologous blood/platelet rich plasma (PRP) injections, prolotherapy, acupuncture, manipulation, and surgery.

Extracorporeal shock wave therapy (ESWT) is a method that aims to provide treatment by focusing high amplitude sound waves on the area of the body to be applied.

PRP is an autologous concentration of human platelets in a small volume of plasma produced by centrifuging a patient's own blood.

This study was designed as a double-blind, prospective, placebo-controlled, randomized study. Participants were randomized into 3 groups: ESWT + therapeutic exercise, ESWT + Sham PRP injection + therapeutic exercise, ESWT + PRP injection + therapeutic exercise.

Visual Pain Scale (VAS), Patient Rated Tennis Elbow Evaluation (PRTEE), Quick Disabilities of the Arm, Shoulder and Hand Score (Quick DASH), SF (Short form) -36 Quality of Life Scale, Handgrip strength with Jamar hydraulic hand dynamometer, Common extensor tendon thicknesses, peritendinous fluid, bone irregularities, calcifications, and diffuse tendon heterogeneity with ultrasound, upper extremity muscle strength with Isomed 2000 isokinetic device will be evaluated.

It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the 4th week and at the 12th week controls.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Not being able to fully cooperate with the study and inability to read and write,
2. Injection (corticosteroid, PRP, etc.) treatment applied to the elbow area within three months,
3. Previous surgery or ESWT treatment in the area to be treated,
4. Pregnant women,
5. Arthritis (rheumatoid arthritis, spondyloarthritis, crystal arthropathies),
6. Those who have a history of direct trauma to the elbow and a history of fracture,
7. Those with a history of malignancy,
8. Bleeding diathesis,
9. Complex regional pain syndrome,
10. Presence of acute systemic infection,
11. Presence of local infection at the injection site,
12. Peripheral vasculopathy,
13. Cervical radiculopathy,
14. 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.

Primary outcomes:
measure: Change from baseline visual analog scale (VAS) elbow pain at 4th and 12th week
timeFrame: baseline and 12th week
Secondary outcomes:
measure: Change from baseline Handgrip strength at 4th and 12th week
timeFrame: baseline and 12th week
measure: Change from baseline Quick Disabilities of the Arm, Shoulder and Hand Score (Quick DASH) at 4th and 12th week
timeFrame: baseline and 12th week
measure: Change from baseline quality of life (Short Form 36 (SF-36)) at 4th and 12th weeks
timeFrame: baseline and 12th week
measure: Change from baseline Ultrasonographic examination at 4th and 12th weeks
timeFrame: baseline and 12th week
measure: Change from baseline upper extremity muscle strength with isokinetic device at 4th and 12th weeks
timeFrame: baseline and 12th week
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Nuran EYVAZ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyonkarahisar Health Sciences University
name: Ali İzzet AKÇİN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.