Epicondylitis, LateralNCT07427368
Comparison of ESWT and Ultrasound-Guided Ozone Injection in Lateral Epicondylitis
A study testing ESWT Device and ozone injection in people with Epicondylitis, Lateral, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis is a common and often debilitating condition characterized by pain over the lateral aspect of the elbow. Although many patients respond to standard conservative treatments, a subset develops a chronic and treatment-resistant form of the condition. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epicondylitis, Lateral
- What is being tested?
- ESWT Device and ozone injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 3 Mar 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Male or female patients between 18 and 65 years of age.
- Clinical Diagnosis: Patients diagnosed with lateral epicondylitis, defined by pain in the lateral epicondyle region for more than 3 months, increased pain on palpation of the lateral epicondyle, and positive provocation tests (Cozen's, Maudsley's, or Mills' tests).
- Symptom Duration: Presence of symptoms for more than 3 months (resistant cases).
- Treatment Failure: Lack of response to first-line conservative treatments (e.g., analgesics, exercise, rest, splinting).
- Radiographic Confirmation: No other pathology detected on direct radiographs of the elbow.
- Injection History: No corticosteroid injection to the affected elbow within the last 6 months.
- Consent: Voluntary participation in the study
Who cannot join
- Elbow Pathology: Presence of elbow problems other than lateral epicondylitis (e.g., loose bodies, rheumatoid nodules).
- Surgical History: History of previous surgery on the affected elbow joint.
- Structural Damage: Presence of tendon rupture.
- Consent: Unwillingness to continue treatment or participate.
- Spinal Pathology: Cervical root pathology (cervical radiculopathy).
- Neuropathy: Diagnosed upper extremity entrapment neuropathy.
Show all 20Show fewer
- Neurological Status: Presence of neurological impairment or deficits.
- Recent Injections: History of injection therapy to the elbow within the last 6 months.
- Recent Therapy: History of physical therapy for the elbow region within the last 6 months.
- Pregnancy: Pregnant women.
- Hematological: Presence of coagulation or bleeding disorders.
- Vascular: Presence of peripheral vasculopathy.
- Pain Syndromes: Presence of Complex Regional Pain Syndrome (CRPS).
- Oncology: History of malignancy.
- Systemic Diseases: Presence of systemic inflammatory or autoimmune disorders (e.g., Rheumatoid Arthritis, SLE).
- Trauma: History of direct trauma to the elbow.
- Medication: Current use of medications that may affect pain levels or muscle strength (e.g., muscle relaxants, analgesics, gabapentinoids).
- Local Infection: Presence of open wounds, infection, or signs of active inflammation in the elbow region.
- Cooperation: Difficulty in cooperation or cognitive inability to follow instructions.
- Enzyme Deficiency: Congenital Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara
About this study
Official title: Comparison of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) and Ultrasound-Guided Ozone Injection Therapy in Patients With Resistant Lateral Epicondylitis
Lateral epicondylitis is a common and often debilitating condition characterized by pain over the lateral aspect of the elbow. Although many patients respond to standard conservative treatments, a subset develops a chronic and treatment-resistant form of the condition.
The primary objective of this randomized comparative clinical trial is to evaluate and compare the therapeutic effectiveness of two intervention modalities: Extracorporeal Shock Wave Therapy (ESWT) and ultrasound-guided ozone injection in patients with chronic lateral epicondylitis.
Read more
Participants who meet the inclusion criteria will be randomly assigned to one of two treatment arms. The first group will receive Extracorporeal Shock Wave Therapy (ESWT), while the second group will receive an ultrasound-guided injection of an ozone-oxygen mixture. Both interventions will be administered once weekly for three consecutive weeks according to their respective standard treatment protocols.
To determine which treatment yields superior clinical and structural outcomes, participants will be evaluated at three time points: baseline (prior to treatment), immediately after completion of the 3-week treatment protocol, and at a 4-week follow-up. Outcome measures will include pain intensity assessed using the Visual Analog Scale (VAS), functional status evaluated with the Patient-Rated Tennis Elbow Evaluation (PRTEE), hand grip strength measured with a dynamometer, and structural tendon changes (tendon thickness and presence of enthesophytes) assessed by high-resolution ultrasonography.
Read the detailed description
Lateral epicondylitis is a painful and often debilitating tendinopathy affecting the common extensor tendon origin. Although most patients respond to standard conservative management, a substantial proportion progress to a chronic, refractory condition. For these resistant cases, identifying effective and minimally invasive treatment options remains a significant clinical challenge.
Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive modality widely used in the management of chronic tendinopathies. Its proposed therapeutic mechanisms include the induction of controlled microtrauma, stimulation of neoangiogenesis, increased local blood flow, and modulation of pain-related signaling pathways, ultimately promoting tissue regeneration.
Medical ozone therapy has emerged as a potential regenerative injection approach. The local administration of an oxygen-ozone gas mixture into the affected tissue is thought to exert anti-inflammatory effects, enhance tissue oxygenation, and stimulate fibroblast activity, thereby supporting cellular repair processes within degenerated tendon tissue.
Although both modalities demonstrate potential therapeutic benefits, direct comparative evidence regarding their effectiveness in chronic, treatment-resistant lateral epicondylitis remains limited. This study aims to compare the clinical and structural outcomes associated with these two treatment approaches. By evaluating both symptom improvement and objective ultrasonographic tendon changes, this trial seeks to provide evidence to inform optimal treatment strategies for chronic cases.
- Conditions
- Epicondylitis, Lateral
- Being tested
- ESWT Device, ozone injection
- Keywords
- ozone therapy, ESWT, Extracorporeal Shockwave Therapy, tennis elbow, Oxygen-Ozone Therapy, lateral epiconylitis
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWT DeviceDevice
Application of extracorporeal shock waves targeted at the common extensor tendon origin at the lateral epicondyle. The therapeutic procedure is performed once a week for 3 consecutive weeks, totaling 3 sessions. Each session includes 2000 impulses.
ozone injectionOther
Injection of a medical oxygen-ozone gas mixture directly into the common extensor tendon origin at the lateral epicondyle. To ensure precise anatomical localization and safety, the procedure is performed under real-time high-resolution ultrasound guidance and strict sterile conditions. The injection is administered once a week for 3 consecutive weeks, totaling 3 sessions.
| Study group | Role | What they receive |
|---|---|---|
| ESWT Group | Active comparator | This group consists of patients diagnosed with lateral epicondylitis resistant to conservative treatment who are randomly allocated to the extracorporeal shock wave therapy arm. Receives: Device: ESWT Device |
| Ozone Injection Group | Active comparator | This group consists of patients diagnosed with lateral epicondylitis resistant to conservative treatment who are randomly allocated to the injection arm. Receives: Other: ozone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Pain intensity was evaluated using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain.
Measured: Baseline, immediately after treatment completion, and 4 weeks after treatment completion.
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Functional disability was assessed using the PRTEE questionnaire. The total score ranges from 0 (no disability) to 100 (significant functional disability).
Measured: Baseline, immediately after treatment completion, and 4 weeks after treatment completion.
Secondary outcomes (2)
Grip Strength
Grip strength was measured using a hand-held dynamometer. Measurements were recorded in kilograms
Measured: Baseline, immediately after treatment completion, and 4 weeks after treatment completion.
Ultrasonographic Evaluation (Common Extensor Tendon Thickness and Spur Presence)
Ultrasonographic assessment included two parameters: 1) The thickness of the common extensor tendon (CET) measured in millimeters (mm) in the longitudinal plane, and 2) The presence or absence of bony spurs at the lateral epicondyle.
Measured: Baseline, immediately after treatment completion, and 4 weeks after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Jun 2025
- Primary completion3 Mar 2026 (estimated)
- Study completion3 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicondylitis, LateralStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- This is a prospective, randomized, comparative study designed to evaluate the efficacy of two different treatment modalities in patients with resistant lateral epicondylitis. Participants will be randomly assigned to two parallel groups (ESWT and Ozone) to compare clinical outcomes.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berke Aras, Medical Doctor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427368
- Sponsor's protocol ID
- E2-25-11166
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) and Ultrasound-Guided Ozone Injection Therapy in Patients With Resistant Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT07427368
- Acronym / sponsor ID
- E2-25-11166
- Conditions
- Epicondylitis, Lateral
- Keywords
- ozone therapy, ESWT, Extracorporeal Shockwave Therapy, tennis elbow, Oxygen-Ozone Therapy, lateral epiconylitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 3 Mar 2026 (estimated)
- Study completion
- 3 Mar 2026 (estimated)
- First posted
- 23 Feb 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.
Lateral epicondylitis is a common and often debilitating condition characterized by pain over the lateral aspect of the elbow. Although many patients respond to standard conservative treatments, a subset develops a chronic and treatment-resistant form of the condition.
The primary objective of this randomized comparative clinical trial is to evaluate and compare the therapeutic effectiveness of two intervention modalities: Extracorporeal Shock Wave Therapy (ESWT) and ultrasound-guided ozone injection in patients with chronic lateral epicondylitis.
Participants who meet the inclusion criteria will be randomly assigned to one of two treatment arms. The first group will receive Extracorporeal Shock Wave Therapy (ESWT), while the second group will receive an ultrasound-guided injection of an ozone-oxygen mixture. Both interventions will be administered once weekly for three consecutive weeks according to their respective standard treatment protocols.
To determine which treatment yields superior clinical and structural outcomes, participants will be evaluated at three time points: baseline (prior to treatment), immediately after completion of the 3-week treatment protocol, and at a 4-week follow-up. Outcome measures will include pain intensity assessed using the Visual Analog Scale (VAS), functional status evaluated with the Patient-Rated Tennis Elbow Evaluation (PRTEE), hand grip strength measured with a dynamometer, and structural tendon changes (tendon thickness and presence of enthesophytes) assessed by high-resolution ultrasonography.
Detailed description
Lateral epicondylitis is a painful and often debilitating tendinopathy affecting the common extensor tendon origin. Although most patients respond to standard conservative management, a substantial proportion progress to a chronic, refractory condition. For these resistant cases, identifying effective and minimally invasive treatment options remains a significant clinical challenge.
Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive modality widely used in the management of chronic tendinopathies. Its proposed therapeutic mechanisms include the induction of controlled microtrauma, stimulation of neoangiogenesis, increased local blood flow, and modulation of pain-related signaling pathways, ultimately promoting tissue regeneration.
Medical ozone therapy has emerged as a potential regenerative injection approach. The local administration of an oxygen-ozone gas mixture into the affected tissue is thought to exert anti-inflammatory effects, enhance tissue oxygenation, and stimulate fibroblast activity, thereby supporting cellular repair processes within degenerated tendon tissue.
Although both modalities demonstrate potential therapeutic benefits, direct comparative evidence regarding their effectiveness in chronic, treatment-resistant lateral epicondylitis remains limited. This study aims to compare the clinical and structural outcomes associated with these two treatment approaches. By evaluating both symptom improvement and objective ultrasonographic tendon changes, this trial seeks to provide evidence to inform optimal treatment strategies for chronic cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, comparative study designed to evaluate the efficacy of two different treatment modalities in patients with resistant lateral epicondylitis. Participants will be randomly assigned to two parallel groups (ESWT and Ozone) to compare clinical outcomes.
| Arm | Type | Receives |
|---|---|---|
| ESWT Group | Active comparator | Device: ESWT DeviceThis group consists of patients diagnosed with lateral epicondylitis resistant to conservative treatment who are randomly allocated to the extracorporeal shock wave therapy arm. |
| Ozone Injection Group | Active comparator | Other: ozone injectionThis group consists of patients diagnosed with lateral epicondylitis resistant to conservative treatment who are randomly allocated to the injection arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: Male or female patients between 18 and 65 years of age.
- Clinical Diagnosis: Patients diagnosed with lateral epicondylitis, defined by pain in the lateral epicondyle region for more than 3 months, increased pain on palpation of the lateral epicondyle, and positive provocation tests (Cozen's, Maudsley's, or Mills' tests).
- Symptom Duration: Presence of symptoms for more than 3 months (resistant cases).
- Treatment Failure: Lack of response to first-line conservative treatments (e.g., analgesics, exercise, rest, splinting).
- Radiographic Confirmation: No other pathology detected on direct radiographs of the elbow.
Key exclusion criteria (20 listed)
- Elbow Pathology: Presence of elbow problems other than lateral epicondylitis (e.g., loose bodies, rheumatoid nodules).
- Surgical History: History of previous surgery on the affected elbow joint.
- Structural Damage: Presence of tendon rupture.
- Consent: Unwillingness to continue treatment or participate.
- Spinal Pathology: Cervical root pathology (cervical radiculopathy).
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 |
|---|---|---|
| ESWT DeviceApplication of extracorporeal shock waves targeted at the common extensor tendon origin at the lateral epicondyle. The therapeutic procedure is performed once a week for 3 consecutive weeks, totaling 3 sessions. Each session includes 2000 impulses. | Device | ESWT Group |
| ozone injectionInjection of a medical oxygen-ozone gas mixture directly into the common extensor tendon origin at the lateral epicondyle. To ensure precise anatomical localization and safety, the procedure is performed under real-time high-resolution ultrasound guidance and strict sterile conditions. The injection is administered once a week for 3 consecutive weeks, totaling 3 sessions. | Other | Ozone Injection Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline, immediately after treatment completion, and 4 weeks after treatment completion.
Pain intensity was evaluated using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain.
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time frame: Baseline, immediately after treatment completion, and 4 weeks after treatment completion.
Functional disability was assessed using the PRTEE questionnaire. The total score ranges from 0 (no disability) to 100 (significant functional disability).
2 secondary outcomes
Grip Strength
Time frame: Baseline, immediately after treatment completion, and 4 weeks after treatment completion.
Ultrasonographic Evaluation (Common Extensor Tendon Thickness and Spur Presence)
Time frame: Baseline, immediately after treatment completion, and 4 weeks after treatment completion
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 23 Feb 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.
Berke Aras, Medical Doctor principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT Device and ozone injection in people with Epicondylitis, Lateral, run by Ankara City Hospital Bilkent 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 7 inclusion and 20 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 23 Feb 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?
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 Duygu Elbaşı, Medical Doctor (+905544739970, duyguelbasi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Baseline, immediately after treatment completion, and 4 weeks after treatment completion.). The study lists 2 primary outcomes in all. 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 23 Feb 2026.