Clinical trial NCT07006389: Factors Affecting Response to Extracorporeal Shock Wave Therapy in Plantar Fasciitis: A Cross-sectional Clinical Study
Official title: Factors Affecting Response to Extracorporeal Shock Wave Therapy in Plantar Fasciitis: A Cross-sectional Clinical Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Plantar Fasciitis
Plantar Heel Pain
Keywords: pain
plantar fasciitis
plantar heel pain
ESWT
extracorporeal shock wave therapy
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a history of plantar fasciitis

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.

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

Primary outcomes:
measure: Calcaneal inclination angle
timeFrame: Day 1
measure: Ankle dorsiflexion degree
timeFrame: Day 1
measure: Plantar fascia thickness
timeFrame: Day 1
measure: Tibial/plantar nerve conduction study with electroneuromyography
timeFrame: Day 1
Secondary outcomes:
measure: Meary angle
timeFrame: Day 1
measure: Plantar calcaneal spurs
timeFrame: Day 1
measure: Heel Tenderness index
timeFrame: Day 1
measure: Foot Function Index
timeFrame: Day 1
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Şişli Hamidiye Etfal Training and Research Hospital
Study officials:
affiliation: Şişli Hamidiye Etfal Taining and Research Hospital
name: Banu Kuran, Professor, MD
role: STUDY_DIRECTOR
References: