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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Plantar Fascitis
• Intervention / Treatment: Device: Ozone Generator; Device: Extracorporeal shock wave therapy device

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Berke Aras, Ass. Professor; Phone Number: +905365851518; Email: drberkearas@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Recruiting
    • Ankara Bilkent City Hospital
    • Contact: Berke Aras, Associate Professor; Phone Number: +905365851518; Email: drberkearas@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound guided ozone injection therapy	Device: Ozone Generator; Ultrasound guided ozone therapy
Active Comparator: Extracorporeal shock wave therapy	Device: Extracorporeal shock wave therapy device; Extracorporeal shock wave therapy device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Estimated): November 15, 2023
• Study Completion (Estimated): November 15, 2023

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: ESWT; ozone therapy
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: E2-23-3838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No