Ozone Injection vs ESWT for Chronic Achilles Tendinopathy

NCT07412652 | Completed

• 1 other identifier: E2-24-6491
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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. The study focuses on changes in pain, functional outcomes, and overall clinical improvement during the follow-up period.

Conditions

Achilles Tendinopathy (AT)

Keywords

Achilles tendinopathy, extracorporeal shock wave therapy,physical therapy modality

Outcome Measures

Primary Outcomes (2)

• Pain intensity (Visual Analog Scale, VAS)

  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)

  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 Outcomes (2)

• Victorian Institute of Sports Assessment-Achilles (VISA-A) score

  Baseline, post-treatment, and 12-week follow-up

• Roles and Maudsley Score (RMS)

  Baseline, post-treatment, and 12-week follow-up

Study Arms (3)

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.

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.

Device: Extracorporeal Shock Wave Therapy (ESWT)

Conventional Conservative Treatment

OTHER

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

Other: Conventional Conservative Treatment

Interventions

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.

Ultrasound-Guided Ozone Injection

Extracorporeal Shock Wave Therapy (ESWT) DEVICE

Extracorporeal shock wave therapy is applied to the affected Achilles tendon according to a standardized treatment protocol.

Extracorporeal Shock Wave Therapy (ESWT)

Conventional Conservative Treatment OTHER

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

Conventional Conservative Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital - Physical Medicine and Rehabilitation Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to group allocation. No other parties are masked in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: May 2, 2025
• Primary Completion: January 2, 2026
• Study Completion: January 15, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

TU (1)