Achilles Tendinopathy (AT)NCT07412652
Ozone Injection vs ESWT for Chronic Achilles Tendinopathy
A study testing Ultrasound-Guided Local Ozone Injection, Extracorporeal Shock Wave Therapy (ESWT) and Conventional Conservative Treatment in people with Achilles Tendinopathy (AT), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical trial compares ultrasound-guided local ozone injection, extracorporeal shock wave therapy, and conventional conservative treatment in patients with chronic Achilles tendinopathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendinopathy (AT)
- What is being tested?
- Ultrasound-Guided Local Ozone Injection, Extracorporeal Shock Wave Therapy (ESWT) and Conventional Conservative Treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2025to 15 Jan 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
- Patients aged 18 to 65 years.
- Patients with a diagnosis of Achilles tendinopathy confirmed by ultrasonography or magnetic resonance imaging (MRI).
- Patients with persistent symptoms despite completion of conservative treatment.
- Volunteers who agree to participate in the study.
Who cannot join
- Patients with symptoms lasting less than 12 weeks.
- Presence of contraindications to extracorporeal shock wave therapy (ESWT), including pregnancy; history of thrombosis; use of anticoagulant medications; coagulation disorders such as hemophilia; systemic conditions; or localized conditions at the treatment site such as active infection or malignant tumors.
- Presence of contraindications to local ozone injection, including pregnancy; glucose-6-phosphate dehydrogenase (G6PD) deficiency; favism; uncontrolled hyperthyroidism; thrombocytopenia; severe cardiovascular conditions; and use of angiotensin-converting enzyme (ACE) inhibitors.
- History of neurological disease, muscle disease, or peripheral vascular disease.
- Presence of congenital or acquired deformities of the knee and/or ankle.
- Receipt of physical therapy modalities applied to the Achilles tendon within the last 6 weeks.
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- Receipt of any therapeutic injection to the Achilles tendon within the last 12 weeks.
- History of direct trauma to the symptomatic Achilles tendon or Achilles tendon rupture.
- History of surgical treatment involving the Achilles tendon or ankle for any reason.
- History of foot or ankle dislocation or fracture within the past 1 year.
- Presence of systemic inflammatory diseases that may affect tendon structure, such as ankylosing spondylitis, reactive arthritis, or psoriatic arthritis.
- Patients with isolated insertional Achilles tendinopathy without tenderness in the mid-portion of the tendon
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital - Physical Medicine and Rehabilitation Hospital
Ankara, Cankaya, 06800
About this study
Official title: Comparison of Ultrasound-Guided Local Ozone Injection and Extracorporeal Shock Wave Therapy in the Treatment of Chronic Achilles Tendinopathy
This randomized controlled clinical trial compares ultrasound-guided local ozone injection, extracorporeal shock wave therapy, and conventional conservative treatment in patients with chronic Achilles tendinopathy. The study focuses on changes in pain, functional outcomes, and overall clinical improvement during the follow-up period.
- Conditions
- Achilles Tendinopathy (AT)
- Being tested
- Ultrasound-Guided Local Ozone Injection, Extracorporeal Shock Wave Therapy (ESWT), Conventional Conservative Treatment
- Keywords
- Achilles tendinopathy, extracorporeal shock wave therapy,physical therapy modality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Local Ozone InjectionOther
Ultrasound-guided local ozone injection is administered to the peritendinous region of the affected Achilles tendon under sterile conditions using a high-frequency linear transducer, according to a standardized treatment protocol.
Extracorporeal Shock Wave Therapy (ESWT)Device
Extracorporeal shock wave therapy is applied to the affected Achilles tendon according to a standardized treatment protocol.
Conventional Conservative TreatmentOther
Conventional conservative treatment consists of a standardized exercise program and activity modification.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Ozone Injection | Active comparator | Participants receive ultrasound-guided local ozone injection administered to the affected Achilles tendon according to a standardized treatment protocol. Receives: Other: Ultrasound-Guided Local Ozone Injection |
| Extracorporeal Shock Wave Therapy (ESWT) | Active comparator | Participants receive extracorporeal shock wave therapy applied to the affected Achilles tendon according to a standardized treatment protocol. Receives: Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Conventional Conservative Treatment | Other | Participants receive conventional conservative treatment consisting of a standardized exercise program and activity modification. Receives: Other: Conventional Conservative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (Visual Analog Scale, VAS)
Pain intensity is assessed using the Visual Analog Scale (VAS).
Measured: Baseline, post-treatment, and 12 weeks after treatment
Pain intensity assessed by Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is used to assess subjective pain intensity related to Achilles tendon pain.
Measured: Baseline, post-treatment, and 12-week follow-up
Secondary outcomes (2)
Victorian Institute of Sports Assessment-Achilles (VISA-A) score
The VISA-A questionnaire is an eight-item validated measure assessing pain, function, and activity limitations in patients with Achilles tendinopathy. The Turkish version has established validity and reliability and is used to monitor treatment effectiveness.
Measured: Baseline, post-treatment, and 12-week follow-up
Roles and Maudsley Score (RMS)
The Roles and Maudsley Score is a validated scoring system used to evaluate the relationship between pain and physical activity level. The Turkish version has demonstrated validity and reliability.
Measured: Baseline, post-treatment, and 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start2 May 2025
- Primary completion2 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendinopathy (AT)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
- This study consists of three parallel groups: Group 1 receives ultrasound-guided local ozone injection, Group 2 receives extracorporeal shock wave therapy (ESWT), Group 3 receives conventional conservative treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Orhan, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412652
- Sponsor's protocol ID
- E2-24-6491
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Local Ozone Injection and Extracorporeal Shock Wave Therapy in the Treatment of Chronic Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT07412652
- Acronym / sponsor ID
- E2-24-6491
- Conditions
- Achilles Tendinopathy (AT)
- Keywords
- Achilles tendinopathy, extracorporeal shock wave therapy,physical therapy modality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 17 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.
This randomized controlled clinical trial compares ultrasound-guided local ozone injection, extracorporeal shock wave therapy, and conventional conservative treatment in patients with chronic Achilles tendinopathy. The study focuses on changes in pain, functional outcomes, and overall clinical improvement during the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study consists of three parallel groups: Group 1 receives ultrasound-guided local ozone injection, Group 2 receives extracorporeal shock wave therapy (ESWT), Group 3 receives conventional conservative treatment.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Ozone Injection | Active comparator | Other: Ultrasound-Guided Local Ozone InjectionParticipants receive ultrasound-guided local ozone injection administered to the affected Achilles tendon according to a standardized treatment protocol. |
| Extracorporeal Shock Wave Therapy (ESWT) | Active comparator | Device: Extracorporeal Shock Wave Therapy (ESWT)Participants receive extracorporeal shock wave therapy applied to the affected Achilles tendon according to a standardized treatment protocol. |
| Conventional Conservative Treatment | Other | Other: Conventional Conservative TreatmentParticipants receive conventional conservative treatment consisting of a standardized exercise program and activity modification. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 65 years.
- Patients with a diagnosis of Achilles tendinopathy confirmed by ultrasonography or magnetic resonance imaging (MRI).
- Patients with persistent symptoms despite completion of conservative treatment.
- Volunteers who agree to participate in the study.
Key exclusion criteria (13 listed)
- Patients with symptoms lasting less than 12 weeks.
- Presence of contraindications to extracorporeal shock wave therapy (ESWT), including pregnancy; history of thrombosis; use of anticoagulant medications; coagulation disorders such as hemophilia; systemic conditions; or localized conditions at the treatment site such as active infection or malignant tumors.
- Presence of contraindications to local ozone injection, including pregnancy; glucose-6-phosphate dehydrogenase (G6PD) deficiency; favism; uncontrolled hyperthyroidism; thrombocytopenia; severe cardiovascular conditions; and use of angiotensin-converting enzyme (ACE) inhibitors.
- History of neurological disease, muscle disease, or peripheral vascular disease.
- Presence of congenital or acquired deformities of the knee and/or ankle.
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 Local Ozone InjectionUltrasound-guided local ozone injection is administered to the peritendinous region of the affected Achilles tendon under sterile conditions using a high-frequency linear transducer, according to a standardized treatment protocol. | Other | Ultrasound-Guided Ozone Injection |
| Extracorporeal Shock Wave Therapy (ESWT)Extracorporeal shock wave therapy is applied to the affected Achilles tendon according to a standardized treatment protocol. | Device | Extracorporeal Shock Wave Therapy (ESWT) |
| Conventional Conservative TreatmentConventional conservative treatment consists of a standardized exercise program and activity modification. | Other | Conventional Conservative Treatment |
Primary outcome
Pain intensity (Visual Analog Scale, VAS)
Time frame: Baseline, post-treatment, and 12 weeks after treatment
Pain intensity is assessed using the Visual Analog Scale (VAS).
Pain intensity assessed by Visual Analog Scale (VAS)
Time frame: Baseline, post-treatment, and 12-week follow-up
The Visual Analog Scale (VAS) is used to assess subjective pain intensity related to Achilles tendon pain.
2 secondary outcomes
Victorian Institute of Sports Assessment-Achilles (VISA-A) score
Time frame: Baseline, post-treatment, and 12-week follow-up
Roles and Maudsley Score (RMS)
Time frame: Baseline, post-treatment, and 12-week follow-up
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 17 Feb 2026.
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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 Local Ozone Injection, Extracorporeal Shock Wave Therapy (ESWT) and Conventional Conservative Treatment in people with Achilles Tendinopathy (AT), 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 4 inclusion and 13 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 17 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?
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?
Pain intensity (Visual Analog Scale, VAS) (time frame: Baseline, post-treatment, and 12 weeks after treatment). 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 17 Feb 2026.