Ozone Injection vs ESWT for Chronic Achilles Tendinopathy

Ankara City Hospital

Status: Completed

Conditions: Achilles Tendinopathy (AT)

Treatments: Device: Extracorporeal Shock Wave Therapy (ESWT); Other: Conventional Conservative Treatment; Other: Ultrasound-Guided Local Ozone Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07412652

E2-24-6491

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 3 patient groups

Ultrasound-Guided Ozone Injection

Active Comparator group

Description:

Participants receive ultrasound-guided local ozone injection administered to the affected Achilles tendon according to a standardized treatment protocol.

Treatment:

Other: Ultrasound-Guided Local Ozone Injection

Extracorporeal Shock Wave Therapy (ESWT)

Active Comparator group

Description:

Participants receive extracorporeal shock wave therapy applied to the affected Achilles tendon according to a standardized treatment protocol.

Treatment:

Device: Extracorporeal Shock Wave Therapy (ESWT)

Conventional Conservative Treatment

Other group

Description:

Participants receive conventional conservative treatment consisting of a standardized exercise program and activity modification.

Treatment:

Other: Conventional Conservative Treatment