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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Conventional Conservative Treatment | Other | Participants receive conventional conservative treatment consisting of a standardized exercise program and activity modification. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-treatment, and 12-week follow-up |
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital - Physical Medicine and Rehabilitation Hospital | Ankara | Cankaya | 06800 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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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.
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Outcome assessors are blinded to group allocation. No other parties are masked in this study.
| 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. |
|
| 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. | Baseline, post-treatment, and 12-week follow-up |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |