Lateral Epicondylitis (Tennis Elbow)LE-TP-ESWTNCT07638488
Trigger Point Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis
A study testing Extracorporeal Shock Wave Therapy in people with Lateral Epicondylitis (Tennis Elbow), run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluates the effect of extracorporeal shock wave therapy applied to the extensor carpi radialis brevis trigger point in patients with lateral epicondylitis. Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Lateral Epicondylitis (Tennis Elbow)
- What is being tested?
- Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2024to 24 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years
- Clinical diagnosis of lateral epicondylitis
- Tenderness over the lateral epicondyle
- Presence of trigger point in the extensor carpi radialis brevis muscle
- Ability to provide written informed consent
Who cannot join
- Peripheral nerve disease involving the ulnar, median, or radial nerve
- Other elbow pathologies such as instability, arthritis, or dermatologic lesions
- Radicular pain
- Previous elbow surgery
- Platelet-rich plasma injection, stem cell injection, corticosteroid injection, or extracorporeal shock wave therapy to the affected elbow within the previous month
- Presence of a pacemaker
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Medicine Hospital
Ankara, Ankara, 06560
About this study
Official title: The Effect of Extracorporeal Shock Wave Therapy Applied to the Trigger Point on Grip Strength, Visual Analog Scale Score, and Common Extensor Tendon Thickness in Patients With Lateral Epicondylitis
This randomized controlled study evaluates the effect of extracorporeal shock wave therapy applied to the extensor carpi radialis brevis trigger point in patients with lateral epicondylitis. Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region. In addition, one group receives active extracorporeal shock wave therapy to the extensor carpi radialis brevis trigger point, while the other group receives sham extracorporeal shock wave therapy to the trigger point. Pain, grip strength, hand function, and common extensor tendon thickness are assessed before treatment and at week 4.
Read the detailed description
Lateral epicondylitis is a common tendinopathic condition characterized by pain over the lateral elbow, reduced grip strength, and limitation in upper extremity function. The extensor carpi radialis brevis tendon and the common extensor tendon origin are frequently involved. Myofascial trigger points in the extensor carpi radialis brevis muscle may also contribute to pain and functional impairment.
This prospective randomized controlled single-blind study investigates whether extracorporeal shock wave therapy applied to the extensor carpi radialis brevis trigger point provides additional clinical and ultrasonographic benefit in patients with lateral epicondylitis. Participants are allocated to two parallel groups. Both groups receive active extracorporeal shock wave therapy to the lateral epicondyle region once weekly for three sessions. The intervention group also receives active extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle. The comparator group receives sham extracorporeal shock wave therapy to the same trigger point area.
Outcome assessments are performed at baseline and at week 4. Pain intensity is assessed using the Visual Analog Scale. Grip strength is measured with a Jamar hand dynamometer. Hand function is assessed using the Duruöz Hand Index. Common extensor tendon thickness is measured by ultrasonography. The primary aim is to determine whether active trigger point extracorporeal shock wave therapy provides additional improvement compared with sham trigger point application when both groups receive active treatment to the lateral epicondyle region.
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Being tested
- Extracorporeal Shock Wave Therapy, Sham Extracorporeal Shock Wave Therapy
- Keywords
- Trigger Point, Extensor Carpi Radialis Brevis, Common Extensor Tendon, Ultrasonography
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyDevice
Active extracorporeal shock wave therapy is applied to the lateral epicondyle region in both groups once weekly for three sessions. In the experimental group, active extracorporeal shock wave therapy is also applied to one trigger point in the extensor carpi radialis brevis muscle.
Sham Extracorporeal Shock Wave TherapyDevice
Sham extracorporeal shock wave therapy is applied to one trigger point in the extensor carpi radialis brevis muscle using a sham applicator that produces a similar sound but does not deliver therapeutic shock wave energy.
| Study group | Role | What they receive |
|---|---|---|
| Active Trigger Point ESWT Group | Experimental | Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region and active extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle, once weekly for three sessions. Receives: Device: Extracorporeal Shock Wave Therapy |
| Sham Trigger Point ESWT Group | Sham comparator | Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region and sham extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle, once weekly for three sessions. Receives: Device: Extracorporeal Shock Wave Therapy; Device: Sham Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Common Extensor Tendon Thickness
Common extensor tendon thickness is measured by ultrasonography using a linear probe with the elbow flexed at 90 degrees and the forearm in mid-supination. Measurements are performed on a longitudinal image at the lateral epicondyle region, perpendicular to the tendon fibers. The change from baseline to week 4 is evaluated
Measured: Baseline and week 4
Secondary outcomes (3)
Change in Pain Intensity Assessed by Visual Analog Scale
Pain intensity is assessed using a 10-cm Visual Analog Scale. A score of 0 indicates no pain and a score of 10 indicates the worst pain.
Measured: Baseline and week 4
Change in Grip Strength
Grip strength is measured using a Jamar hand dynamometer. Measurements are performed with the participant seated, the shoulder adducted, the elbow flexed at 90 degrees, the forearm in neutral position, and the wrist in neutral position. Three consecutive measurements are obtained from the affected side, and the mean value is used for analysis. The change from baseline to week 4 is evaluated.
Measured: Baseline and week 4
Change in Functional Disability Assessed by the Duruöz Hand Index
functional disability is assessed using the Duruöz Hand Index. The scale includes 18 items evaluating difficulties in daily activities involving hand use. Total scores range from 0 to 90, with higher scores indicating greater disability. The change from baseline to week 4 is evaluated.
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start21 Oct 2024
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Epicondylitis (Tennis Elbow)Studies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants are randomized into two parallel groups. Both groups receive active extracorporeal shock wave therapy to the lateral epicondyle region. One group receives active extracorporeal shock wave therapy to the extensor carpi radialis brevis trigger point, while the other group receives sham extracorporeal shock wave therapy to the same trigger point area.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sueda SOYDAN, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638488
- Sponsor's protocol ID
- LE-ESWT-ECRB-2026
- Other IDs
- KD24/04
- Acronym
- LE-TP-ESWT
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Extracorporeal Shock Wave Therapy Applied to the Trigger Point on Grip Strength, Visual Analog Scale Score, and Common Extensor Tendon Thickness in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT07638488
- Acronym / sponsor ID
- LE-TP-ESWT / LE-ESWT-ECRB-2026
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Keywords
- Trigger Point, Extensor Carpi Radialis Brevis, Common Extensor Tendon, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 10 Jun 2026 (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.
This randomized controlled study evaluates the effect of extracorporeal shock wave therapy applied to the extensor carpi radialis brevis trigger point in patients with lateral epicondylitis. Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region. In addition, one group receives active extracorporeal shock wave therapy to the extensor carpi radialis brevis trigger point, while the other group receives sham extracorporeal shock wave therapy to the trigger point. Pain, grip strength, hand function, and common extensor tendon thickness are assessed before treatment and at week 4.
Detailed description
Lateral epicondylitis is a common tendinopathic condition characterized by pain over the lateral elbow, reduced grip strength, and limitation in upper extremity function. The extensor carpi radialis brevis tendon and the common extensor tendon origin are frequently involved. Myofascial trigger points in the extensor carpi radialis brevis muscle may also contribute to pain and functional impairment.
This prospective randomized controlled single-blind study investigates whether extracorporeal shock wave therapy applied to the extensor carpi radialis brevis trigger point provides additional clinical and ultrasonographic benefit in patients with lateral epicondylitis. Participants are allocated to two parallel groups. Both groups receive active extracorporeal shock wave therapy to the lateral epicondyle region once weekly for three sessions. The intervention group also receives active extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle. The comparator group receives sham extracorporeal shock wave therapy to the same trigger point area.
Outcome assessments are performed at baseline and at week 4. Pain intensity is assessed using the Visual Analog Scale. Grip strength is measured with a Jamar hand dynamometer. Hand function is assessed using the Duruöz Hand Index. Common extensor tendon thickness is measured by ultrasonography. The primary aim is to determine whether active trigger point extracorporeal shock wave therapy provides additional improvement compared with sham trigger point application when both groups receive active treatment to the lateral epicondyle region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomized into two parallel groups. Both groups receive active extracorporeal shock wave therapy to the lateral epicondyle region. One group receives active extracorporeal shock wave therapy to the extensor carpi radialis brevis trigger point, while the other group receives sham extracorporeal shock wave therapy to the same trigger point area.
| Arm | Type | Receives |
|---|---|---|
| Active Trigger Point ESWT Group | Experimental | Device: Extracorporeal Shock Wave TherapyParticipants receive active extracorporeal shock wave therapy to the lateral epicondyle region and active extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle, once weekly for three sessions. |
| Sham Trigger Point ESWT Group | Sham comparator | Device: Extracorporeal Shock Wave Therapy, Device: Sham Extracorporeal Shock Wave TherapyParticipants receive active extracorporeal shock wave therapy to the lateral epicondyle region and sham extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle, once weekly for three sessions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 50 years
- Clinical diagnosis of lateral epicondylitis
- Tenderness over the lateral epicondyle
- Presence of trigger point in the extensor carpi radialis brevis muscle
- Ability to provide written informed consent
Key exclusion criteria (7 listed)
- Peripheral nerve disease involving the ulnar, median, or radial nerve
- Other elbow pathologies such as instability, arthritis, or dermatologic lesions
- Radicular pain
- Previous elbow surgery
- Platelet-rich plasma injection, stem cell injection, corticosteroid injection, or extracorporeal shock wave therapy to the affected elbow within the previous month
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 |
|---|---|---|
| Extracorporeal Shock Wave TherapyActive extracorporeal shock wave therapy is applied to the lateral epicondyle region in both groups once weekly for three sessions. In the experimental group, active extracorporeal shock wave therapy is also applied to one trigger point in the extensor carpi radialis brevis muscle. | Device | Active Trigger Point ESWT Group, Sham Trigger Point ESWT Group |
| Sham Extracorporeal Shock Wave TherapySham extracorporeal shock wave therapy is applied to one trigger point in the extensor carpi radialis brevis muscle using a sham applicator that produces a similar sound but does not deliver therapeutic shock wave energy. | Device | Sham Trigger Point ESWT Group |
Primary outcome
Change in Common Extensor Tendon Thickness
Time frame: Baseline and week 4
Common extensor tendon thickness is measured by ultrasonography using a linear probe with the elbow flexed at 90 degrees and the forearm in mid-supination. Measurements are performed on a longitudinal image at the lateral epicondyle region, perpendicular to the tendon fibers. The change from baseline to week 4 is evaluated
3 secondary outcomes
Change in Pain Intensity Assessed by Visual Analog Scale
Time frame: Baseline and week 4
Change in Grip Strength
Time frame: Baseline and week 4
Change in Functional Disability Assessed by the Duruöz Hand Index
Time frame: Baseline and week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and ethical restrictions.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy in people with Lateral Epicondylitis (Tennis Elbow), run by Gazi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 29 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Common Extensor Tendon Thickness (time frame: Baseline and week 4). 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 29 Jun 2026.