search
Back to results

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

Primary Purpose

Plantar Fascitis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ozone Generator
Extracorporeal shock wave therapy device
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring ozone therapy, ESWT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ankara Bilkent City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrasound guided ozone injection therapy

Extracorporeal shock wave therapy

Arm Description

Outcomes

Primary Outcome Measures

Visual Analog Scale
measurement for pain severity, It is a value between 0-100. "0" means no pain and "100" means maximum pain.

Secondary Outcome Measures

plantar fascia thickness
sonographic measurement for plantar fascia
Foot Function İndex
measurements for foot function. An increase in the value indicates worse foot functions.

Full Information

First Posted
September 5, 2023
Last Updated
September 11, 2023
Sponsor
Ankara City Hospital Bilkent
search

1. Study Identification

Unique Protocol Identification Number
NCT06041230
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis
Keywords
ozone therapy, ESWT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided ozone injection therapy
Arm Type
Active Comparator
Arm Title
Extracorporeal shock wave therapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Ozone Generator
Intervention Description
Ultrasound guided ozone therapy
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave therapy device
Intervention Description
Extracorporeal shock wave therapy device
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
measurement for pain severity, It is a value between 0-100. "0" means no pain and "100" means maximum pain.
Time Frame
pre-treatment, immediately post-treatment and three months follow-up
Secondary Outcome Measure Information:
Title
plantar fascia thickness
Description
sonographic measurement for plantar fascia
Time Frame
pre-treatment, immediately post-treatment and three months follow-up
Title
Foot Function İndex
Description
measurements for foot function. An increase in the value indicates worse foot functions.
Time Frame
pre-treatment, immediately post-treatment and three months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Berke Aras, Ass. Professor
Phone
+905365851518
Email
drberkearas@gmail.com
Facility Information:
Facility Name
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berke Aras, Associate Professor
Phone
+905365851518
Email
drberkearas@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs