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

Afyonkarahisar Health Sciences University

Status: Completed

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

Treatments: Other: ESWT+Exercise; Procedure: Sham PRP+ESWT+Exercise; Procedure: PRP+ESWT+Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05602571

LEPRPESWT22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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91 participants in 3 patient groups

ESWT+Exercise

Experimental group

Description:

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.

Treatment:

Other: ESWT+Exercise

PRP+ESWT+Exercise

Active Comparator group

Description:

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

Treatment:

Procedure: PRP+ESWT+Exercise

Sham PRP+ESWT+Exercise

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham PRP+ESWT+Exercise