Treatment of Lateral Epicondylalgia With Shock Waves

Not Applicable

Recruiting

• Conditions: Epicondylitis of the Elbow; Epicondylitis, Lateral
• Interventions: Other: shock waves placebo treatment; Other: Radial shock waves treatment; Other: Focal Shock Waves treatment

• Registration Number: NCT06587412
• Lead Sponsor: University of Alcala

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Study First Posted: 2024-09-19
• Status Verified: 2025-03
• Study Start: 2025-03-12
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-09-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Shock Waves	shock waves placebo treatment	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.
Radial Shock Wave Treatment	Radial shock waves 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.
Focal Shock Wave Treatment	Focal Shock Waves 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.

Primary Outcome Measures

Name	Time	Method
Pain with Visual Analogue Scale (VAS)	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 Outcome Measures

Name	Time	Method
Grip strength	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.
Patient Rated Tennis Elbow Evaluation (PRTEE)	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
The Global Rating of Change (GROC)	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.

Trial Locations

Locations (1)

Centro Investigación Fisioterapia y Dolor; 🇪🇸 Alcalá de Henares, Madrid, Spain