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

NCT07006389 | Enrolling By Invitation

• 1 other identifier: 12.31.2024/approval no:4684
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis; Plantar Heel Pain

Keywords

pain; plantar fasciitis; plantar heel pain; ESWT; extracorporeal shock wave therapy

Outcome Measures

Primary Outcomes (4)

• Calcaneal inclination angle

  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.

  Day 1

• Ankle dorsiflexion degree

  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.

  Day 1

• Plantar fascia thickness

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

  Day 1

• Tibial/plantar nerve conduction study with electroneuromyography

  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.

  Day 1

Secondary Outcomes (4)

• Meary angle

  Day 1

• Plantar calcaneal spurs

  Day 1

• Heel Tenderness index

  Day 1

• Foot Function Index

  Day 1

Study Arms (2)

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

Responder group to ESWT

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a history of plantar fasciitis

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasciitis, Plantar; Pain

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Banu Kuran, Professor, MD

  Şişli Hamidiye Etfal Taining and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

TU (1)