Clinical trial NCT06041230: Comparison of the Efficiency of ESWT and Ozone Injection in Patients With Chronic Plantar Fasciitis
Official title: Comparison of the Efficiency of Extracorporeal Shock Wave Therapy and Ultrasound-Guided Ozone Injection in Patients With Chronic Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fascitis
Keywords: ozone therapy
ESWT
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: pre-treatment, immediately post-treatment and three months follow-up
Secondary outcomes:
measure: plantar fascia thickness
timeFrame: pre-treatment, immediately post-treatment and three months follow-up
measure: Foot Function İndex
timeFrame: pre-treatment, immediately post-treatment and three months follow-up
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
References: