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

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Recruiting
CT.gov ID
NCT06041230
Collaborator
(none)
48
1
2
4.1
11.6

Study Details

Study Description

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
  • Device: Ozone Generator
  • Device: Extracorporeal shock wave therapy device
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 12, 2023
Anticipated Primary Completion Date :
Nov 15, 2023
Anticipated Study Completion Date :
Nov 15, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Visual Analog Scale [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 [pre-treatment, immediately post-treatment and three months follow-up]

    sonographic measurement for plantar fascia

  2. Foot Function İndex [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

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Ankara Bilkent City Hospital Ankara Turkey 06100

Sponsors and Collaborators

  • Ankara City Hospital Bilkent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Berke Aras, Associate Professor, Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT06041230
Other Study ID Numbers:
  • E2-23-3838
First Posted:
Sep 18, 2023
Last Update Posted:
Sep 18, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Berke Aras, Associate Professor, Ankara City Hospital Bilkent
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 18, 2023