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

NCT ID: NCT06041230

Last Updated: 2023-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-12

Study Completion Date

2023-11-15

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.

Detailed Description

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Conditions

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Plantar Fascitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Ultrasound guided ozone injection therapy

Group Type ACTIVE_COMPARATOR

Ozone Generator

Intervention Type DEVICE

Ultrasound guided ozone therapy

Extracorporeal shock wave therapy

Group Type ACTIVE_COMPARATOR

Extracorporeal shock wave therapy device

Intervention Type DEVICE

Extracorporeal shock wave therapy device

Interventions

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Ozone Generator

Ultrasound guided ozone therapy

Intervention Type DEVICE

Extracorporeal shock wave therapy device

Extracorporeal shock wave therapy device

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Berke Aras

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Berke Aras, Ass. Professor

Role: CONTACT

+905365851518

Facility Contacts

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Berke Aras, Associate Professor

Role: primary

+905365851518

Other Identifiers

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E2-23-3838

Identifier Type: -

Identifier Source: org_study_id

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