Radial or Focus Extracorporeal Shock Wave Therapy in Epin Calcanei

NCT06356064 | Completed

• 1 other identifier: E2-23-3834
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  0 min , 10 is maximum pain score

  Before and after treatment baseline, 4th week, 12 th week

• Functional Foot Index

  0 is no pain 10 is max pain, and 0 is no deficiency 10 is the maximum deficiency and 0 is no activity limitation 10 is the maximum activity limitation score.

  Before and after treatment baseline, 4th week, 12 th week

Secondary Outcomes (1)

• Radiographic assesment, epin size

  Before and after treatment baseline, 4th week, 12 th week

Study Arms (2)

rESWT( Radial Extracorporeal shock wave therapy)

EXPERIMENTAL

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

Device: Extracorporeal shock wave therapy

fESWT(Focused Extracorporeal shock wave therapy))

EXPERIMENTAL

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

Device: Extracorporeal shock wave therapy

Interventions

Extracorporeal shock wave therapy DEVICE

Radİal ESWT and focus ESWT

fESWT(Focused Extracorporeal shock wave therapy)); rESWT( Radial Extracorporeal shock wave therapy)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Özge TEZEN

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heel Spur

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Exostoses; Hyperostosis; Bone Diseases; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 10, 2024
• Study Start: May 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: January 15, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)