Lateral Epicondylitis (Tennis Elbow)NCT07550322
Dry Needling vs ESWT in Lateral Epicondylitis
A study testing Ultrasound-guided dry needling and Extracorporeal Shock Wave Therapy in people with Lateral Epicondylitis (Tennis Elbow), run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized single-blind controlled trial aims to compare the effectiveness of ultrasound-guided dry needling and extracorporeal shock wave therapy in patients with lateral epicondylitis. Sixty participants aged 18-65 years will be randomized into two groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis (Tennis Elbow)
- What is being tested?
- Ultrasound-guided dry needling and Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 14 Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years
- Clinical diagnosis of lateral epicondylitis
- Symptoms persisting for at least 6 weeks
- Pain over the lateral epicondyle aggravated by wrist extension or gripping activities
- Positive provocative tests consistent with lateral epicondylitis (e.g., Cozen's test and/or Mill's test)
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Previous surgery for lateral epicondylitis in the affected elbow
- Corticosteroid injection, PRP injection, prolotherapy, mesotherapy, or ESWT to the affected elbow within the previous 6 months
- Bilateral lateral epicondylitis requiring simultaneous treatment
- Cervical radiculopathy or other neurologic disorders affecting the upper extremity
- Inflammatory rheumatic disease
- Elbow osteoarthritis or significant structural elbow pathology
Show all 11Show fewer
- Full-thickness tendon tear or other major tendon injury on imaging
- Pregnancy or breastfeeding
- Active infection, skin lesion, or wound at the treatment site
- Use of anticoagulant therapy or bleeding disorder
- Inability to comply with follow-up assessments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpasa Numune Training and Research Hospital
Istanbul, Istanbul, 34662
About this study
Official title: Ultrasound-Guided Dry Needling Versus Extracorporeal Shock Wave Therapy in Lateral Epicondylitis: A Randomized Single-Blind Controlled Trial
This randomized single-blind controlled trial aims to compare the effectiveness of ultrasound-guided dry needling and extracorporeal shock wave therapy in patients with lateral epicondylitis. Sixty participants aged 18-65 years will be randomized into two groups. The dry needling group will receive ultrasound-guided tendon fenestration once weekly for five sessions, while the ESWT group will receive radial extracorporeal shock wave therapy once weekly for five sessions. All participants will be given a standardized home exercise program. Pain, function, grip strength, pressure pain threshold, quality of life, and ultrasonographic findings will be evaluated at baseline, post-treatment, and at 3- and 6-month follow-up. The primary outcome is change in pain severity measured by Visual Analog Scale.
Read the detailed description
This prospective, randomized, parallel-group, single-blind clinical trial is designed to compare the effectiveness of ultrasound-guided dry needling and extracorporeal shock wave therapy in patients with lateral epicondylitis. Participants aged 18-65 years with symptoms lasting at least six weeks will be randomly assigned in a 1:1 ratio using computer-generated block randomization with sealed opaque envelopes. Due to the nature of the interventions, participants and treating physicians will not be blinded; however, all clinical and ultrasonographic assessments will be performed by an investigator blinded to treatment allocation.
Participants in the dry needling group will receive ultrasound-guided tendon fenestration targeting the pathologic area of the common extensor tendon. The procedure will be performed once weekly for five sessions. Participants in the ESWT group will receive radial extracorporeal shock wave therapy applied to the most tender point over the lateral epicondyle using standard treatment parameters. ESWT will also be administered once weekly for five sessions.
All participants will receive a standardized home exercise program consisting of eccentric strengthening and stretching exercises for the wrist extensors. Assessments will be performed at baseline, immediately after treatment, and at 3- and 6-month follow-up visits. Outcome measures will include pain intensity, functional status, grip strength, pressure pain threshold, quality of life, and ultrasonographic tendon characteristics including grayscale and Power Doppler findings.
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Being tested
- Ultrasound-guided dry needling, Extracorporeal Shock Wave Therapy
- Keywords
- Lateral epicondylitis, Dry needling, Ultrasound-guided dry needling, Extracorporeal shock wave therapy, ESWT, Musculoskeletal ultrasound
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided dry needlingProcedure or surgery
Dry needling will be performed under ultrasound guidance targeting the tendinosis area of the common extensor tendon. The procedure will be applied once weekly for five sessions.
Extracorporeal Shock Wave TherapyDevice
Radial extracorporeal shock wave therapy will be applied using standard parameters (10-15 Hz, 1.5-2.5 bar, 2000 pulses) once weekly for five sessions.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Dry Needling | Experimental | Participants will receive ultrasound-guided dry needling applied to the common extensor tendon once weekly for five sessions. All participants will also perform a standardized home exercise program. Receives: Procedure: Ultrasound-guided dry needling |
| Extracorporeal Shock Wave Therapy | Active comparator | Participants will receive radial extracorporeal shock wave therapy applied to the lateral epicondyle once weekly for five sessions. All participants will also perform a standardized home exercise program. Receives: Device: Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using a 10-cm visual analog scale. Change from baseline to immediate post-treatment, upto 3 months, and upto 6 months will be analyzed. The Visual Analogue Scale (VAS) was used to assess the severity of elbow pain during activity. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity and therefore a worse outcome.
Measured: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Secondary outcomes (6)
Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) score
PRTEE questionnaire will be used to evaluate pain and functional disability in lateral epicondylitis. The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a 15-item, elbow-specific questionnaire assessing pain and functional disability. It comprises a Pain subscale (5 items; score range, 0-50) and a Function subscale (10 items; converted score range, 0-50). The total PRTEE score ranges from 0 to 100, where 0 indicates no pain or functional disability and 100 indicates the greatest possible pain and disability. Higher scores indicate a worse outcome.
Measured: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in grip strength
Grip strength will be measured using a hand dynamometer in kilograms.
Measured: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in pressure pain threshold
Pressure pain threshold will be measured using a handheld algometer over the lateral epicondyle.
Measured: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in quality of life measured by SF-12
Quality of life will be assessed using the Short Form-12 questionnaire. The 12-Item Short Form Health Survey (SF-12) was used to assess health-related quality of life. It generates two separate summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each component score ranges from 0 to 100, where 0 represents the worst health status and 100 represents the best health status. Higher scores indicate better physical or mental health and therefore a better outcome. The PCS and MCS scores were evaluated separately; no overall SF-12 total score was calculated.
Measured: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in ultrasonographic tendon thickness
Common extensor tendon thickness will be measured using musculoskeletal ultrasound.
Measured: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in Power Doppler neovascularization score
Neovascularization will be evaluated using semi-quantitative Power Doppler scoring. The Color Doppler Ultrasound Neovascularization Score was used to grade vascular activity within the common extensor tendon. Scores range from 0 to 4: grade 0 indicates no Doppler activity; grade 1 indicates a single vessel; grade 2 indicates Doppler activity occupying less than 25% of the region of interest; grade 3 indicates activity occupying 25%-50% of the region of interest; and grade 4 indicates activity occupying more than 50% of the region of interest. Higher scores indicate greater neovascularization and a worse ultrasonographic tendon outcome.
Measured: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Feb 2026
- Primary completion14 Sep 2026
- Study completion14 Sep 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.
- 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
- Two parallel groups will be randomized in a 1:1 ratio to receive either ultrasound-guided dry needling or extracorporeal shock wave therapy. Both groups will receive five treatment sessions and will be followed for six months.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Gunay, MD, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550322
- Sponsor's protocol ID
- 2024-KAEK-18-5087
- Status last verified
- Feb 2026
- First submitted
- 11 Apr 2026
- Last updated
- 16 Sep 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. De-identified data may be available from the corresponding investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Dry Needling Versus Extracorporeal Shock Wave Therapy in Lateral Epicondylitis: A Randomized Single-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07550322
- Acronym / sponsor ID
- 2024-KAEK-18-5087
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Keywords
- Lateral epicondylitis, Dry needling, Ultrasound-guided dry needling, Extracorporeal shock wave therapy, ESWT, Musculoskeletal ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 14 Sep 2026 (actual)
- Study completion
- 14 Sep 2026 (actual)
- First posted
- 24 Apr 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 single-blind controlled trial aims to compare the effectiveness of ultrasound-guided dry needling and extracorporeal shock wave therapy in patients with lateral epicondylitis. Sixty participants aged 18-65 years will be randomized into two groups. The dry needling group will receive ultrasound-guided tendon fenestration once weekly for five sessions, while the ESWT group will receive radial extracorporeal shock wave therapy once weekly for five sessions. All participants will be given a standardized home exercise program. Pain, function, grip strength, pressure pain threshold, quality of life, and ultrasonographic findings will be evaluated at baseline, post-treatment, and at 3- and 6-month follow-up. The primary outcome is change in pain severity measured by Visual Analog Scale.
Detailed description
This prospective, randomized, parallel-group, single-blind clinical trial is designed to compare the effectiveness of ultrasound-guided dry needling and extracorporeal shock wave therapy in patients with lateral epicondylitis. Participants aged 18-65 years with symptoms lasting at least six weeks will be randomly assigned in a 1:1 ratio using computer-generated block randomization with sealed opaque envelopes. Due to the nature of the interventions, participants and treating physicians will not be blinded; however, all clinical and ultrasonographic assessments will be performed by an investigator blinded to treatment allocation.
Participants in the dry needling group will receive ultrasound-guided tendon fenestration targeting the pathologic area of the common extensor tendon. The procedure will be performed once weekly for five sessions. Participants in the ESWT group will receive radial extracorporeal shock wave therapy applied to the most tender point over the lateral epicondyle using standard treatment parameters. ESWT will also be administered once weekly for five sessions.
All participants will receive a standardized home exercise program consisting of eccentric strengthening and stretching exercises for the wrist extensors. Assessments will be performed at baseline, immediately after treatment, and at 3- and 6-month follow-up visits. Outcome measures will include pain intensity, functional status, grip strength, pressure pain threshold, quality of life, and ultrasonographic tendon characteristics including grayscale and Power Doppler findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups will be randomized in a 1:1 ratio to receive either ultrasound-guided dry needling or extracorporeal shock wave therapy. Both groups will receive five treatment sessions and will be followed for six months.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Dry Needling | Experimental | Procedure: Ultrasound-guided dry needlingParticipants will receive ultrasound-guided dry needling applied to the common extensor tendon once weekly for five sessions. All participants will also perform a standardized home exercise program. |
| Extracorporeal Shock Wave Therapy | Active comparator | Device: Extracorporeal Shock Wave TherapyParticipants will receive radial extracorporeal shock wave therapy applied to the lateral epicondyle once weekly for five sessions. All participants will also perform a standardized home exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 65 years
- Clinical diagnosis of lateral epicondylitis
- Symptoms persisting for at least 6 weeks
- Pain over the lateral epicondyle aggravated by wrist extension or gripping activities
- Positive provocative tests consistent with lateral epicondylitis (e.g., Cozen's test and/or Mill's test)
Key exclusion criteria (11 listed)
- Previous surgery for lateral epicondylitis in the affected elbow
- Corticosteroid injection, PRP injection, prolotherapy, mesotherapy, or ESWT to the affected elbow within the previous 6 months
- Bilateral lateral epicondylitis requiring simultaneous treatment
- Cervical radiculopathy or other neurologic disorders affecting the upper extremity
- Inflammatory rheumatic disease
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 |
|---|---|---|
| Ultrasound-guided dry needlingDry needling will be performed under ultrasound guidance targeting the tendinosis area of the common extensor tendon. The procedure will be applied once weekly for five sessions. | Procedure or surgery | Ultrasound-Guided Dry Needling |
| Extracorporeal Shock Wave TherapyRadial extracorporeal shock wave therapy will be applied using standard parameters (10-15 Hz, 1.5-2.5 bar, 2000 pulses) once weekly for five sessions. | Device | Extracorporeal Shock Wave Therapy |
Primary outcome
Change in pain intensity measured by Visual Analog Scale (VAS)
Time frame: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Pain intensity will be assessed using a 10-cm visual analog scale. Change from baseline to immediate post-treatment, upto 3 months, and upto 6 months will be analyzed. The Visual Analogue Scale (VAS) was used to assess the severity of elbow pain during activity. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity and therefore a worse outcome.
6 secondary outcomes
Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) score
Time frame: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in grip strength
Time frame: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in pressure pain threshold
Time frame: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in quality of life measured by SF-12
Time frame: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in ultrasonographic tendon thickness
Time frame: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
Change in Power Doppler neovascularization score
Time frame: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).
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 16 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. De-identified data may be available from the corresponding investigator upon reasonable request.
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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 Ultrasound-guided dry needling and Extracorporeal Shock Wave Therapy in people with Lateral Epicondylitis (Tennis Elbow), run by Haydarpasa Numune Training and Research Hospital 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 6 inclusion and 11 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 16 Sep 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. 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 pain intensity measured by Visual Analog Scale (VAS) (time frame: Baseline (Week 0), end of treatment after 5 weekly sessions (Week 5), 12 weeks post-treatment (Week 17), and 24 weeks post-treatment (Week 29).). 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 16 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.