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Enrolling by invitation NCT07006389

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

Observational Plantar Fasciitis Plantar Heel Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Plantar Fasciitis, Plantar Heel Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Calcaneal inclination angle [Time frame: Day 1]
  • Ankle dorsiflexion degree [Time frame: Day 1]
  • Plantar fascia thickness [Time frame: Day 1]
  • Tibial/plantar nerve conduction study with electroneuromyography [Time frame: Day 1]
Secondary outcome measures (4)
  • Meary angle [Time frame: Day 1]
  • Plantar calcaneal spurs [Time frame: Day 1]
  • Heel Tenderness index [Time frame: Day 1]
  • Foot Function Index [Time frame: Day 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Şişli Hamidiye Etfal Training and Research Hospital — Istanbul

Identifiers

NCT: NCT07006389 · 12.31.2024/approval no:4684

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗