Epicondylitis of the ElbowNCT06587412
Treatment of Lateral Epicondylalgia With Shock Waves
A study testing Radial shock waves treatment and Focal Shock Waves treatment in people with Epicondylitis of the Elbow and Epicondylitis, Lateral, run by University of Alcala at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epicondylitis of the Elbow, Epicondylitis, Lateral
- What is being tested?
- Radial shock waves treatment and Focal Shock Waves treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2025to 20 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain in the lateral epicondyle >3 months
- Pain when performing resisted grip
- Positive Cozen test
- Positive Maudsley test
Who cannot join
- Pregnancy
- Systemic diseases (Fibromyalgia, Diabetes, Arthritis)
- Local infection or Cancer
- Recent treatments (Physiotherapy, Corticosteroids)-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Centro Investigación Fisioterapia y Dolor
Alcalá de Henares, Madrid, 28806
Centro M Fisioterapia y Dolor, PhD, 683 37 83 91, clinica.fisio@fgua.es
About this study
Official title: Radial Shock Waves Versus Focal Shock Waves in the Treatment of Lateral Epicondylalgia
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.
- Conditions
- Epicondylitis of the Elbow, Epicondylitis, Lateral
- Being tested
- Radial shock waves treatment, Focal Shock Waves treatment, shock waves placebo treatment
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial shock waves treatmentOther
Subjects in this group will receive radial shock waves
Focal Shock Waves treatmentOther
Subjects in this group will receive focal shock waves
shock waves placebo treatmentOther
Subjects in this group will receive a shock waves placebo treatment with very low energy settings
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Radial shock waves treatment |
| 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. Receives: Other: Focal Shock Waves treatment |
| 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. Receives: Other: shock waves placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline pain at 6 month
Secondary outcomes (3)
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.
Measured: Change from Baseline pain at 6 month
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
Measured: 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.
Measured: Change from Baseline pain at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start12 Mar 2025
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicondylitis of the ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587412
- Sponsor's protocol ID
- CEIM/2024/4/101
- Status last verified
- Jun 2026
- First submitted
- 4 Sep 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Shock Waves Versus Focal Shock Waves in the Treatment of Lateral Epicondylalgia
- ClinicalTrials.gov ID
- NCT06587412
- Acronym / sponsor ID
- CEIM/2024/4/101
- Conditions
- Epicondylitis of the Elbow, Epicondylitis, Lateral
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radial Shock Wave Treatment | Experimental | Other: Radial shock waves treatmentPatients 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 | Experimental | Other: Focal Shock Waves treatmentPatients 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. |
| Placebo Shock Waves | Placebo comparator | Other: shock waves placebo treatmentSubjects 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pain in the lateral epicondyle >3 months
- Pain when performing resisted grip
- Positive Cozen test
- Positive Maudsley test
Key exclusion criteria (4 listed)
- Pregnancy
- Systemic diseases (Fibromyalgia, Diabetes, Arthritis)
- Local infection or Cancer
- Recent treatments (Physiotherapy, Corticosteroids)-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial shock waves treatmentSubjects in this group will receive radial shock waves | Other | Radial Shock Wave Treatment |
| Focal Shock Waves treatmentSubjects in this group will receive focal shock waves | Other | Focal Shock Wave Treatment |
| shock waves placebo treatmentSubjects in this group will receive a shock waves placebo treatment with very low energy settings | Other | Placebo Shock Waves |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial shock waves treatment and Focal Shock Waves treatment in people with Epicondylitis of the Elbow and Epicondylitis, Lateral, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanira Rodriguez-García, Master (34 918855142, yanira.rodriguez@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain with Visual Analogue Scale (VAS) (time frame: Change from Baseline pain at 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.