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

NCT06041230 | Unknown

• 1 other identifier: E2-23-3838
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plantar Fascitis

Keywords

ozone therapy; ESWT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• plantar fascia thickness

  pre-treatment, immediately post-treatment and three months follow-up

• Foot Function İndex

  pre-treatment, immediately post-treatment and three months follow-up

Study Arms (2)

Ultrasound guided ozone injection therapy

ACTIVE COMPARATOR

Device: Ozone Generator

Extracorporeal shock wave therapy

ACTIVE COMPARATOR

Device: Extracorporeal shock wave therapy device

Interventions

Ozone Generator DEVICE

Ultrasound guided ozone therapy

Ultrasound guided ozone injection therapy

Extracorporeal shock wave therapy device DEVICE

Extracorporeal shock wave therapy device

Extracorporeal shock wave therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Berke Aras, Ass. Professor

CONTACT

+905365851518; drberkearas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 18, 2023
• Study Start: July 12, 2023
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

TU (1)