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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

Tracking Information
First Submitted Date  ICMJE September 5, 2023
First Posted Date  ICMJE September 18, 2023
Last Update Posted Date September 18, 2023
Actual Study Start Date  ICMJE July 12, 2023
Estimated Primary Completion Date November 15, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2023)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2023)
  • plantar fascia thickness [ Time Frame: pre-treatment, immediately post-treatment and three months follow-up ]
    sonographic measurement for plantar fascia
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Efficiency of ESWT and Ozone Injection in Patients With Chronic Plantar Fasciitis
Official Title  ICMJE Comparison of the Efficiency of Extracorporeal Shock Wave Therapy and Ultrasound-Guided Ozone Injection in Patients With Chronic Plantar Fasciitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plantar Fascitis
Intervention  ICMJE
  • Device: Ozone Generator
    Ultrasound guided ozone therapy
  • Device: Extracorporeal shock wave therapy device
    Extracorporeal shock wave therapy device
Study Arms  ICMJE
  • Active Comparator: Ultrasound guided ozone injection therapy
    Intervention: Device: Ozone Generator
  • Active Comparator: Extracorporeal shock wave therapy
    Intervention: Device: Extracorporeal shock wave therapy device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2023)		 48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2023
Estimated Primary Completion Date November 15, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Berke Aras, Ass. Professor +905365851518 drberkearas@gmail.com
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06041230
Other Study ID Numbers  ICMJE E2-23-3838
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Current Responsible Party Berke Aras, Ankara City Hospital Bilkent
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ankara City Hospital Bilkent
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ankara City Hospital Bilkent
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP