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NCT Number: NCT06587412

Treatment of Lateral Epicondylalgia With Shock Waves

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.

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Key information

Conditions

Epicondylitis of the Elbow Arm Injuries Elbow Injuries Elbow Tendinopathy Epicondylitis, Lateral Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28806, Spain

Location status: Recruiting

Location contact

Centro M Fisioterapia y Dolor, PhD

CONTACT

[email protected]

683 37 83 91

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)-

Treatment and study plan

Radial shock waves treatment

Other

Subjects in this group will receive radial shock waves

Focal Shock Waves treatment

Other

Subjects in this group will receive focal shock waves

shock waves placebo treatment

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanira Rodriguez-García, Master

CONTACT

[email protected]

34 918855142

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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