Comparison of the Efficiency of ESWT and Ozone Injection in Patients With Chronic Plantar Fasciitis

Study Overview
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Brief Summary
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Extracorporeal Shock Wave Therapy (ESWT) is a conservative treatment method that has been widely used in musculoskeletal diseases in recent years. Its mechanism is to provide hyperstimulation and vascularity increase with the help of acoustic waves focused on a specific area, thus accelerating healing and reducing pain. This method, which is frequently used in plantar fasciitis, is frequently applied to patients whose symptoms persist despite first-line treatment strategies. Ozone injections have been frequently used in musculoskeletal disorders in recent years and are mainly used in osteoarthritis, osteomyelitis, tendon, fascia and ligament injuries, vertebra and disc pathologies and neuropathic pain. Analgesic effect on musculoskeletal system (release of endorphins, activation of antinociceptive system, reduction of edema) anti-inflammatory effect (regulation of cytokine release, reduction of superoxide radicals, modulation of prostaglandin), regulation of local oxygenation and circulation, tissue repair (neutralization of preteolytic enzymes, fibroblast proliferation) and has an antimicrobial effect. Although it is also used in the treatment of plantar fasciitis, there are limited articles on this subject in the literature. In our study, it was aimed to compare the effectiveness of ESWT and ozone injection therapy, which are two treatment strategies with regenerative action mechanisms, in patients with resistant plantar fasciitis.

Official Title
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Comparison of the Efficiency of Extracorporeal Shock Wave Therapy and Ultrasound-Guided Ozone Injection in Patients With Chronic Plantar Fasciitis

Conditions
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Plantar Fascitis

Intervention / Treatment
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* Device: Ozone Generator
* Device: Extracorporeal shock wave therapy device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be over 18 years old Heel pain lasting longer than 3 months Localized pain and tenderness on palpation on the medial aspect of the calcaneal tuberosity when the ankle is fully dorsiflexed. In the first step of walking, >50 mm according to VAS. and description of pain Presence of plantar fasciitis typical findings on ultrasonography (thickening more than 4 mm in the proximal plantar fascia with changes in fibril pattern) Failure to respond to conservative treatment before (nonsteroidal anti-inflammatory drugs, stretching, heel cushion, shoe modifications, orthotics, cold, heat, taping, massage) Exclusion Criteria: being under the age of 18 Any skin lesions in the heel area Inflammatory, rheumatic arthritis Having a history of fracture, trauma or operation in the heel area Systemic infection or malignancy Having a pacemaker Local injection to the heel area in the last 6 months or use of topical or oral nonsteroidal anti-inflammatory drugs in the last 2 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound guided ozone injection therapy<br> | Device: Ozone Generator<br>* Ultrasound guided ozone therapy<br>|
| Active Comparator: Extracorporeal shock wave therapy<br> | Device: Extracorporeal shock wave therapy device<br>* Extracorporeal shock wave therapy device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | measurement for pain severity, It is a value between 0-100. 0 means no pain and 100 means maximum pain. | pre-treatment, immediately post-treatment and three months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plantar fascia thickness | sonographic measurement for plantar fascia | pre-treatment, immediately post-treatment and three months follow-up | 
| Foot Function İndex | measurements for foot function. An increase in the value indicates worse foot functions. | pre-treatment, immediately post-treatment and three months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ozone therapy, ESWT