Ozone Injection vs ESWT for Chronic Achilles Tendinopathy

February 9, 2026 updated by: Berna Orhan, Ankara City Hospital Bilkent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Cankaya
      • Ankara, Cankaya, Turkey (Türkiye), 06800
        • Ankara Bilkent City Hospital - Physical Medicine and Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound-Guided Ozone Injection
Participants receive ultrasound-guided local ozone injection administered to the affected Achilles tendon according to a standardized treatment protocol.
Other: Ultrasound-Guided Local Ozone Injection
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.
Active Comparator: Extracorporeal Shock Wave Therapy (ESWT)
Participants receive extracorporeal shock wave therapy applied to the affected Achilles tendon according to a standardized treatment protocol.
Device: Extracorporeal Shock Wave Therapy (ESWT)
Extracorporeal shock wave therapy is applied to the affected Achilles tendon according to a standardized treatment protocol.
Other: Conventional Conservative Treatment
Participants receive conventional conservative treatment consisting of a standardized exercise program and activity modification.
Other: Conventional Conservative Treatment
Conventional conservative treatment consists of a standardized exercise program and activity modification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, post-treatment, and 12 weeks after treatment
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.
Baseline, post-treatment, and 12-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Victorian Institute of Sports Assessment-Achilles (VISA-A) score
Time Frame: Baseline, post-treatment, and 12-week follow-up
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.
Baseline, post-treatment, and 12-week follow-up
Roles and Maudsley Score (RMS)
Time Frame: Baseline, post-treatment, and 12-week follow-up
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.
Baseline, post-treatment, and 12-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2025

Primary Completion (Actual)

January 2, 2026

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2-24-6491

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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