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

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ClinicalTrials.gov Identifier: NCT06041230
Recruitment Status : Recruiting
First Posted : September 18, 2023
Last Update Posted : September 18, 2023
Sponsor:
Information provided by (Responsible Party):
Berke Aras, Ankara City Hospital Bilkent

Study Description
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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.


Condition or disease Intervention/treatment Phase
Plantar Fascitis Device: Ozone Generator Device: Extracorporeal shock wave therapy device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Efficiency of Extracorporeal Shock Wave Therapy and Ultrasound-Guided Ozone Injection in Patients With Chronic Plantar Fasciitis
Actual Study Start Date : July 12, 2023
Estimated Primary Completion Date : November 15, 2023
Estimated Study Completion Date : November 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ozone Shock

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: pre-treatment, immediately post-treatment and three months follow-up ]
    measurement for pain severity, It is a value between 0-100. "0" means no pain and "100" means maximum pain.


Secondary Outcome Measures :
  1. plantar fascia thickness [ Time Frame: pre-treatment, immediately post-treatment and three months follow-up ]
    sonographic measurement for plantar fascia

  2. Foot Function İndex [ Time Frame: pre-treatment, immediately post-treatment and three months follow-up ]
    measurements for foot function. An increase in the value indicates worse foot functions.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06041230


Contacts
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Contact: Berke Aras, Ass. Professor +905365851518 drberkearas@gmail.com

Locations
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Turkey
Ankara Bilkent City Hospital Recruiting
Ankara, Turkey, 06100
Contact: Berke Aras, Associate Professor    +905365851518    drberkearas@gmail.com   
Sponsors and Collaborators
Ankara City Hospital Bilkent
More Information
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Responsible Party: Berke Aras, Associate Professor, Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier: NCT06041230    
Other Study ID Numbers: E2-23-3838
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Berke Aras, Ankara City Hospital Bilkent:
ozone therapy
ESWT
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases