Treatment of Lateral Epicondylalgia With Shock Waves

University of Alcala

Status: Enrolling

Conditions: Epicondylitis of the Elbow; Epicondylitis, Lateral

Treatments: Other: Radial shock waves treatment; Other: Focal Shock Waves treatment; Other: shock waves placebo treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06587412

CEIM/2024/4/101

Details and patient eligibility

About

Lateral epicondylalgia (LET) is characterized by pain, decreased muscle strength of the wrist extensor muscles, and disability. Among the treatments proposed in the literature, both focal shockwave therapy and radial shockwave therapy have been considered effective in the management of this musculoskeletal disorder. The objective of this study is to compare the safety and effectiveness of these two shockwave applications on the signs and symptoms of subjects with lateral epicondylalgia. In this clinical trial, subjects will be evaluated for elbow pain using a Visual Analog Scale (VAS), grip strength using a handheld dynamometer, and degree of disability using the Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE). A six-month follow-up will be performed.

Patients will be randomly divided into three groups. The first group will receive radial shock waves (rESWT), the second group will receive focal shock waves (fESWT), and the third group, which will act as a control, will receive a placebo treatment with very low energy parameters according to the literature.

Subjects will receive three sessions, one session per week.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pain in the lateral epicondyle >3 months
• Pain when performing resisted grip
• Positive Cozen test
• Positive Maudsley test

Exclusion criteria

• Pregnancy
• Systemic diseases (Fibromyalgia, Diabetes, Arthritis)
• Local infection or Cancer
• Recent treatments (Physiotherapy, Corticosteroids)-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 3 patient groups, including a placebo group

Radial Shock Wave Treatment

Experimental group

Description:

Patients assigned to this group will receive three sessions. During each session, 2000 pulses will be administered using a radial shock wave generator, with a pressure of 2.5 bars and a frequency of 8 Hz.

Treatment:

Other: Radial shock waves treatment

Focal Shock Wave Treatment

Experimental group

Description:

Patients assigned to this group will receive three sessions. During each session, 2000 pulses will be delivered by a focal shock wave generator, with an energy flux density of 0.2 mJ/mm² and a frequency of 4 Hz.

Treatment:

Other: Focal Shock Waves treatment

Placebo Shock Waves

Placebo Comparator group

Description:

Subjects in this group will receive a placebo treatment with very low energy settings, designed to simulate therapy without offering real therapeutic effects. This group will receive 20 pulses per session, with an energy flux density of 0.08 mJ/mm².

Treatment:

Other: shock waves placebo treatment