Factors Affecting Response to Extracorporeal Shock Wave Therapy in Plantar Fasciitis: A Cross-sectional Clinical Study

NCT ID: NCT07006389

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-07-01

Brief Summary

Heel pain is a problem that affects daily life activities and quality of life. Extracorporeal shock wave therapy (ESWT) is a treatment used for heel pain. However, some people do not benefit from ESWT treatment. The aim of this study is to determine the factors that affect the response to ESWT in the treatment of heel pain.

Detailed Description

Plantar heel pain is one of the reasons that affect daily life activities. There are many treatment methods for this. Extracorporeal shock wave therapy (ESWT) is one of them. However, some patients do not respond to ESWT treatment. In this study, patients were divided into 2 groups as those who did not respond to ESWT treatment in terms of pain (less than 50% decrease in pain level) or those with recurrence of pain and those who responded to treatment. Patients who had passed 3-6 months after ESWT constituted the study groups. These two groups will be compared in terms of age, gender, occupation, weight, height, Body Mass Index (BMI), side: right / left / bilateral, calcaneal angle, Meary angle, presence of spur on X-ray (size in mm if present), dorsiflexion angle degree, plantar fascia thickness with ultrasonography, tibial / plantar nerve conduction study evaluated with electroneuromyography, Visual Analog Scale, Heel Sensitivity Index and Foot Function Index.

Conditions

Plantar Fasciitis; Plantar Heel Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Non-responder group to ESWT

Patients who had less than 50% response in the Visual Analog Scale (VAS) after ESWT and patients who had \>50% VAS regression in the first month after ESWT and whose pain recurred afterwards

No interventions assigned to this group

Responder group to ESWT

Patients who had \>50% VAS regression in the 6th month were included in the group that responded to ESWT treatment.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• >18 years
• Unresponsive to conservative treatments (physical therapy, rest, exercises, anti-inflammatory medical treatment, insoles, etc.)
• Patients who have received ESWT treatment and 3-6 months have passed since ESWT

Exclusion Criteria

• History of injection therapy including steroids after ESWT treatment
• Those taking NSAIDs in the last 2 weeks
• Those with a history of trauma or surgery to the foot or ankle
• Presence of rheumatic disease affecting the foot or ankle (e.g. spondyloarthritis, etc.)
• Malignancy
• Pregnancy

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

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Selda Çiftci

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Banu Kuran, Professor, MD

Role: STUDY_DIRECTOR

Şişli Hamidiye Etfal Taining and Research Hospital

Locations

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

12.31.2024/approval no:4684

Identifier Type: -

Identifier Source: org_study_id