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NCT Number: NCT07006389

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

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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Plantar Heel Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Calcaneal inclination angle

    Time frame: Day 1

    This angle is established on a weight-bearing lateral foot radiograph between the calcaneal inclination axis (i.e., the lowest portion of the calcaneus) and the supporting horizontal surface. A cut-off point of ≤19° is used to diagnose symptomatic pes planus/flatfoot.

  2. Ankle dorsiflexion degree

    Time frame: Day 1

    The patient is in a prone position with the ankle on the test side away from the base and the leg extended. The therapist will stabilize the tibia. The normal range of ankle dorsiflexion is 20 degrees. Normal plantar flexion is 50 degrees.

  3. Plantar fascia thickness

    Time frame: Day 1

    To be measured by ultrasound; typically shows increased fascial thickness (>4.0 mm) and a hypoechoic fascia.

  4. Tibial/plantar nerve conduction study with electroneuromyography

    Time frame: Day 1

    Nerve conductions show decreased amplitude of the compound muscle action potential (CMAP) of the tibial nerve stimulated at the ankle and recorded from the abductor hallucis and abductor digiti minimi. Sensory and mixed conduction studies are usually performed with centering techniques.

Secondary outcomes

  1. Meary angle

    Time frame: Day 1

    The Meary angle has been used to determine the apex of the deformity on lateral weight-bearing foot radiographs in patients with pes cavus and pes planus. It is the angle between a line drawn through the longitudinal axes of the talus (mid-talus axis) and the first metatarsal (first metatarsal axis). It can be used to classify the severity of the deformity; mild: <15º, moderate: 15-30º, severe: >30º

  2. Plantar calcaneal spurs

    Time frame: Day 1

    Classically, on plain radiography, the presence of a bony spur extending inferomedially from the calcaneus in the sagittal image will be determined, and its size in mm will be determined.

  3. Heel Tenderness index

    Time frame: Day 1

    0=no pain; 1=painful; 2=painful and whines; 3=painful, whines, and withdraws

  4. Foot Function Index

    Time frame: Day 1

    The FFI consists of 23 items divided into 3 subscales that quantify the impact of foot pathology on pain, disability, and activity limitation in patients. Pain, disability, and activity limitation subscale scores range from 0 to 100.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

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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