Treatment of Lateral Epicondylalgia With Shock Waves

NCT06587412 | Recruiting

• 1 other identifier: CEIM/2024/4/101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epicondylitis of the Elbow; Epicondylitis, Lateral

Outcome Measures

Primary Outcomes (1)

• Pain with Visual Analogue Scale (VAS)

  The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured where "0" on the far left is no pain and "10" on the far right is the worst pain possible.

  Change from Baseline pain at 6 month

Secondary Outcomes (3)

• Grip strength

  Change from Baseline pain at 6 month

• Patient Rated Tennis Elbow Evaluation (PRTEE)

  Change from Baseline pain at 6 month

• The Global Rating of Change (GROC)

  Change from Baseline pain at 6 month

Study Arms (3)

Radial Shock Wave Treatment

EXPERIMENTAL

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.

Other: Radial shock waves treatment

Focal Shock Wave Treatment

EXPERIMENTAL

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.

Other: Focal Shock Waves treatment

Placebo Shock Waves

PLACEBO COMPARATOR

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.

Other: shock waves placebo treatment

Interventions

Radial shock waves treatment OTHER

Subjects in this group will receive radial shock waves

Radial Shock Wave Treatment

Focal Shock Waves treatment OTHER

Subjects in this group will receive focal shock waves

Focal Shock Wave Treatment

shock waves placebo treatment OTHER

Subjects in this group will receive a shock waves placebo treatment with very low energy settings

Placebo Shock Waves

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28806, Spain

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yanira Rodriguez-García, Master

CONTACT

34 918855142; yanira.rodriguez@edu.uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: March 12, 2025
• Primary Completion: April 20, 2026
• Study Completion (Estimated): June 20, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)