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

A

Ankara City Hospital

Status

Enrolling

Conditions

Plantar Fascitis

Treatments

Device: Extracorporeal shock wave therapy device
Device: Ozone Generator

Study type

Interventional

Funder types

Other

Identifiers

NCT06041230
E2-23-3838

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups

Ultrasound guided ozone injection therapy
Active Comparator group
Treatment:
Device: Ozone Generator
Extracorporeal shock wave therapy
Active Comparator group
Treatment:
Device: Extracorporeal shock wave therapy device

Trial contacts and locations

1

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Central trial contact

Berke Aras, Ass. Professor

Data sourced from clinicaltrials.gov

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