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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2024-01-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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ESWT+Exercise

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.

Group Type EXPERIMENTAL

ESWT+Exercise

Intervention Type 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.

PRP+ESWT+Exercise

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

Group Type ACTIVE_COMPARATOR

PRP+ESWT+Exercise

Intervention Type 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).

Sham PRP+ESWT+Exercise

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

Group Type SHAM_COMPARATOR

Sham PRP+ESWT+Exercise

Intervention Type 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).

Interventions

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ESWT+Exercise

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.

Intervention Type OTHER

PRP+ESWT+Exercise

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).

Intervention Type PROCEDURE

Sham PRP+ESWT+Exercise

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).

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No