Radial or Focus Extracorporeal Shock Wave Therapy in Epin Calcanei

NCT ID: NCT06356064

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2024-01-15

Brief Summary

Objective: The aim of the study was to investigate the effectiveness of radial and focused ESWT treatment on pain, function, and size of the calcaneal spur in patients with a clinical and radiological diagnosis of epin calcanei.

Methods: A total of 112 patients aged between 18 and 95 years were randomly divided into two groups: group 1 received rESWT (2.4 bar 12 hz 2000 beats), and group 2 received fESWT (0.14 bar 14 hz 1000 beats) three times a week for three weeks. All patients were evaluated using the Visual Analog Scale (VAS)-pain and Foot Function Index (FFI) before and after the treatment, at 4 weeks and 12 weeks. Epin size was measured radiographically in the patients before and after the treatment at the 12-week follow-up.

Conditions

Spur, Heel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

rESWT( Radial Extracorporeal shock wave therapy)

rESWT(2.4 bar, 12 hz, 2000 beats), to painful calcaneal area, three sessions, once a week, for total of three weeks

Group Type: EXPERIMENTAL

Extracorporeal shock wave therapy

Intervention Type: DEVICE

Radİal ESWT and focus ESWT

fESWT(Focused Extracorporeal shock wave therapy))

fESWT (0.14 bar, 14 hz, 1000 beats), to painful calcaneal area, three sessions, once a week, for total of three weeks

Group Type: EXPERIMENTAL

Extracorporeal shock wave therapy

Intervention Type: DEVICE

Radİal ESWT and focus ESWT

Interventions

Extracorporeal shock wave therapy

Radİal ESWT and focus ESWT

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Presence of heel pain for at least four weeks,
• Receiving no medical treatment, injection, physical or surgical treatment for the last four weeks and
• Agreed to participate in the study.

Exclusion Criteria

• History of fracture or surgery,
• Polyneuropathy,
• Rheumatological diseases,
• Coagulation disorders,
• Tumor,
• Thrombosis,
• Soft tissue or bone infection,
• Pregnancy and lactation,
• Epilepsy,
• Presence of a pacemaker.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Özge TEZEN

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E2-23-3834

Identifier Type: -

Identifier Source: org_study_id