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

Plantar Fascitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041230
• Other study ID #: E2-23-3838
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: September 2023
• Source: Ankara City Hospital Bilkent
• Contact: Berke Aras, Ass. Professor
• Phone: +905365851518
• Email: drberkearas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

Device:
• Ozone Generator
Ultrasound guided ozone therapy
• Extracorporeal shock wave therapy device
Extracorporeal shock wave therapy device

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	plantar fascia thickness	sonographic measurement for plantar fascia	pre-treatment, immediately post-treatment and three months follow-up
Secondary	Foot Function Index	measurements for foot function. An increase in the value indicates worse foot functions.	pre-treatment, immediately post-treatment and three months follow-up