NCT07626723

Brief Summary

Extracorporeal shock wave therapy (ESWT) has become widely preferred in Turkey and worldwide in recent years for the treatment of musculoskeletal diseases due to its non-invasive nature, ease of application, and low risk of complications, as it does not require surgical intervention. However, there is no consensus in the literature regarding the energy level used in ESWT applications, the frequency of application, and especially the ideal number of sessions. Different centers apply varying protocols in clinical practice, which can lead to heterogeneity in treatment outcomes. Scientifically determining the effect of variation in the number of ESWT sessions on clinical outcomes is important for establishing standard treatment protocols. Therefore, the aim of our study is to contribute to the existing literature by investigating the effect of variation in the number of ESWT sessions on clinical parameters such as pain, functional status, and quality of life in the treatment of chronic plantar fasciitis, and to develop more effective and evidence-based treatment approaches in patient management.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Extracorporeal Shock Wave TherapyUltrasonographyPlantar Fasciitis

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    In this scale, pain intensity is generally rated from "absence of pain" (0 points) to "imagined most severe pain" (10 points on a 10-point scale) (Wewers et al., 1990). The pain intensity scoring ranges are: \<3 mild pain, 3-6 moderate pain, \>6 severe pain. VAS is a widely used and practical scale for chronic pain worldwide.

    baseline, 3th week, 6th week, 12th week

Secondary Outcomes (4)

  • Food Function Index

    baseline, 3th week, 6th week, 12th week

  • Pain Pressure Threshold

    baseline, 3th week, 6th week, 12th week

  • Timed up and go test

    baseline, 3th week, 6th week, 12th week

  • Ultrasound Measurement of Plantar Fascia Thickness

    baseline, 3th week, 6th week, 12th week

Study Arms (3)

Group A

EXPERIMENTAL

ESWT treatment will not be given to this group; instead, exercise therapy will be performed by the patient alone for 3 weeks. Plantar fascia stretching exercises, gastrosoleus stretching exercises, and foot intrinsic muscle strengthening exercises will be taught to the patients by the same physiotherapist with over 5 years of clinical experience and expertise in these areas, and they will be asked to perform these exercises 10 times twice a day for a total of 3 weeks.

Other: Exercise group

Group B

EXPERIMENTAL

A physiotherapist with over 5 years of clinical experience will apply radial ESWT treatment to the most painful point in the heel area and surrounding soft tissues, targeting the attachment site of the plantar fascia on the medial calcaneus. The treatment will be performed at a frequency of 10 Hz, a pressure of 2.5-3 bar, and 2000 pulses, once a week for a total of 3 sessions. The exercises taught to the exercise group will also be taught to this group, and they will be asked to perform them 10 times twice a day for a total of 3 weeks.

Other: Exercise groupOther: 3 ESWT sessions

Group C

EXPERIMENTAL

The same physiotherapist, with over 5 years of clinical experience, will apply radial ESWT treatment to the most painful point in the heel area and surrounding soft tissues, targeting the attachment site of the plantar fascia on the medial calcaneus. The treatment will consist of 2000 pulses at a frequency of 10 Hz and a pressure of 2.5-3 bar, once a week for a total of 5 sessions. The exercises taught to the exercise group will also be taught to this group, and they will be instructed to perform them 10 times twice a day for a total of 3 weeks.

Other: Exercise groupOther: 5 ESWT sessions

Interventions

Exercise groupOTHER

exercise

Group AGroup BGroup C
3 ESWT sessionsOTHER

exercise and ESWT

Group B
5 ESWT sessionsOTHER

exercise and ESWT

Group C

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-65, both male and female, diagnosed with plantar fasciitis based on anamnesis and physical examination.
  • Patients must have had symptoms for at least 3 months.
  • Patients must consent to participate in the study according to the informed consent form.

You may not qualify if:

  • Complaint lasting less than 3 months
  • Having received an injection in the heel area within the last 6 months
  • Having applied physical therapy modalities to the heel area within the last 6 months
  • Bilateral complaint
  • Pregnancy
  • Malignancy
  • Epilepsy
  • History of cardiac pacemaker
  • Anticoagulant use
  • History of systemic inflammatory disease
  • History of fracture or surgery in the lower extremity
  • Presence of an open wound in the heel area
  • Hypersensitivity in the patient
  • Systemic infection in the patient
  • Uncontrolled hypertension in the patient
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran Training and Research Hospital

Kırşehir, Turkey (Türkiye)

Location

Related Publications (2)

  • Avraham D, Sokolov R, Arieli I, Stav O, Herman A, Oulianski M. [PLANTAR FASCIOPATHY - DIAGNOSIS AND TREATMENT]. Harefuah. 2025 Feb;164(2):103-107. Hebrew.

    PMID: 39987479BACKGROUND

  • Aleid AM, Alyabis NA, Aldanyowi SN, Albinsaad LS, AlAidarous HA, Aleid ZM, AlMutair AS. Efficacy of platelet-rich plasma versus corticosteroid injections in recovery from plantar fasciitis: A systematic review and meta-analysis. J Taibah Univ Med Sci. 2025 Feb 25;20(1):120-128. doi: 10.1016/j.jtumed.2025.01.002. eCollection 2025 Feb.

    PMID: 40092568BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Officials

  • tuğçe meryem bucağa, MD

    Kırşehir Ahi Evran Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuğçe Meryem Bucağa, MD

CONTACT

+095445627270tmbucaga@gmail.com

Nazife Kapan Tunçer, Asst. Prof.

CONTACT

+095555839701nazifekapan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 4, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 15, 2027

Last Updated

June 4, 2026

Record last verified: 2026-06

Locations

TU(1)