Treatment of Lateral Epicondylalgia With Shock Waves
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radial shock waves treatment, Focal Shock Waves treatment, shock waves placebo treatment.
- Who it may be relevant to
- Registry conditions: Epicondylitis of the Elbow, Epicondylitis, Lateral. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Radial Shock Waves Versus Focal Shock Waves in the Treatment of Lateral Epicondylalgia
Overview
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.
Interventions
- Other Radial shock waves treatment
Subjects in this group will receive radial shock waves - Other Focal Shock Waves treatment
Subjects in this group will receive focal shock waves - Other shock waves placebo treatment
Subjects in this group will receive a shock waves placebo treatment with very low energy settings
Primary outcome measures
- Pain with Visual Analogue Scale (VAS) [Time frame: Change from Baseline pain at 6 month]
Secondary outcome measures (3)
- Grip strength [Time frame: Change from Baseline pain at 6 month]
- Patient Rated Tennis Elbow Evaluation (PRTEE) [Time frame: Change from Baseline pain at 6 month]
- The Global Rating of Change (GROC) [Time frame: Change from Baseline pain at 6 month]
Eligibility criteria
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)-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Centro Investigación Fisioterapia y Dolor — Alcalá de Henares
Identifiers
NCT: NCT06587412 · CEIM/2024/4/101