Achilles Tendinopathy (AT)
Conditions
Keywords
Achilles tendinopathy, extracorporeal shock wave therapy,physical therapy modality
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.
Interventions
OTHERUltrasound-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.
Extracorporeal shock wave therapy is applied to the affected Achilles tendon according to a standardized treatment protocol.
Conventional conservative treatment consists of a standardized exercise program and activity modification.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors are blinded to group allocation. No other parties are masked in this study.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (Visual Analog Scale, VAS) | Baseline, post-treatment, and 12 weeks after treatment | Pain intensity is assessed using the Visual Analog Scale (VAS). |
| Pain intensity assessed by Visual Analog Scale (VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Victorian Institute of Sports Assessment-Achilles (VISA-A) score | 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. |
| Roles and Maudsley Score (RMS) | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed