Treatment of Lateral Epicondylalgia With Shock Waves

NCT ID: NCT06587412

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-12

Study Completion Date

2025-12-20

Brief Summary

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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

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Conditions

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Epicondylitis of the Elbow Epicondylitis, Lateral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Radial shock waves treatment

Intervention Type OTHER

Subjects in this group will receive radial shock waves

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.

Group Type EXPERIMENTAL

Focal Shock Waves treatment

Intervention Type OTHER

Subjects in this group will receive focal shock waves

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.

Group Type PLACEBO_COMPARATOR

shock waves placebo treatment

Intervention Type OTHER

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

Interventions

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Radial shock waves treatment

Subjects in this group will receive radial shock waves

Intervention Type OTHER

Focal Shock Waves treatment

Subjects in this group will receive focal shock waves

Intervention Type OTHER

shock waves placebo treatment

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

Intervention Type OTHER

Eligibility Criteria

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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)-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Daniel Pecos Martín

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Yanira Rodriguez-García, Master

Role: CONTACT

34 918855142

Facility Contacts

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Centro M Fisioterapia y Dolor, PhD

Role: primary

683 37 83 91

Other Identifiers

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CEIM/2024/4/101

Identifier Type: -

Identifier Source: org_study_id

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