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Completed

NCT Number: NCT06356064

Radial or Focus Extracorporeal Shock Wave Therapy in Epin Calcanei

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.

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Key information

Conditions

Spur, Heel Bone Diseases Exostoses Foot Diseases Heel Spur Hyperostosis Musculoskeletal Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Özge TEZEN

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal Shock Wave Therapy

Device

Radİal ESWT and focus ESWT

Primary outcomes

  1. Visual Analog Scale

    Time frame: Before and after treatment baseline, 4th week, 12 th week

    0 min , 10 is maximum pain score

  2. Functional Foot Index

    Time frame: Before and after treatment baseline, 4th week, 12 th week

    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.

Secondary outcomes

  1. Radiographic assesment, epin size

    Time frame: Before and after treatment baseline, 4th week, 12 th week

    A decrease in the size of the epin is an indicator of recovery.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Investigation of The Effectiveness of Extracorporeal Shock Wave Therapy in Patients Diagnosed With Epin Calcanei: Comparison of Radial and Focus Applications

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 10, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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