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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radial Shock Wave Treatment | Experimental | 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. |
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| Focal Shock Wave Treatment | Experimental | 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. |
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| Placebo Shock Waves | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radial shock waves treatment | Other | Subjects in this group will receive radial shock waves |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain with Visual Analogue Scale (VAS) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Grip strength | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanira Rodriguez-GarcÃa, Master | Contact | 34 918855142 | yanira.rodriguez@edu.uah.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Investigación Fisioterapia y Dolor | Recruiting | Alcalá de Henares | Madrid | 28806 | Spain |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| Focal Shock Waves treatment | Other | Subjects in this group will receive focal shock waves |
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| shock waves placebo treatment | Other | Subjects in this group will receive a shock waves placebo treatment with very low energy settings |
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| Patient Rated Tennis Elbow Evaluation (PRTEE) |
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) | 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 |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |