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Completed

NCT Number: NCT07412652

Ozone Injection vs ESWT for 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital - Physical Medicine and Rehabilitation Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Ultrasound-Guided Local Ozone Injection

Other

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 Treatment

Other

Conventional conservative treatment consists of a standardized exercise program and activity modification.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of Ultrasound-Guided Local Ozone Injection and Extracorporeal Shock Wave Therapy in the Treatment of Chronic Achilles Tendinopathy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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