Treatment of Lateral Epicondylalgia With Shock Waves

June 1, 2026 updated by: Prof. Dr. Daniel Pecos Martín, University of Alcala

Radial Shock Waves Versus Focal Shock Waves in the Treatment of Lateral Epicondylalgia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28806
        • Recruiting
        • Centro Investigación Fisioterapia y Dolor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radial Shock Wave Treatment
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
Subjects in this group will receive radial shock waves
Experimental: Focal Shock Wave Treatment
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
Subjects in this group will receive focal shock waves
Placebo Comparator: Placebo Shock Waves
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
Subjects in this group will receive a shock waves placebo treatment with very low energy settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain with Visual Analogue Scale (VAS)
Time Frame: Change from Baseline pain at 6 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip strength
Time Frame: Change from Baseline pain at 6 month
Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It will be recorded using a hand-held dynamometer. The subject is asked to exert grip strength until pain appears. It is measured in newtons.
Change from Baseline pain at 6 month
Patient Rated Tennis Elbow Evaluation (PRTEE)
Time Frame: Change from Baseline pain at 6 month
The PRTEE is a population specific 15-item questionnaire designed to measure forearm pain and disability associated with lateral epicondyle tendinopathy. 0% is the best and 100% is the worst disability outcome
Change from Baseline pain at 6 month
The Global Rating of Change (GROC)
Time Frame: Change from Baseline pain at 6 month
It's a scale that assesses whether the patient condition has gotten worse, better, or stayed the same and to quantify the magnitude of that change, typically following treatment.Subjects will make global ratings of changes regarding their level of well-being from their neck pain since the initial examination on a 15-point self-report scale (from -7 to 7), where -7 is the worst possible value and 7 is the best possible value.
Change from Baseline pain at 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

June 20, 2027

Study Registration Dates

First Submitted

September 4, 2024

First Submitted That Met QC Criteria

September 4, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIM/2024/4/101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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