NCT06846931

Brief Summary

The aim of this study was to investigate the effects of extracorporeal shock wave therapy and low-intensity laser therapy on pain, functionality, plantar fascia thickness and balance in patients with plantar fasciitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

March 7, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
Last Updated

December 31, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

February 21, 2025

Last Update Submit

December 25, 2025

Conditions

Keywords

RehabilitationExtracorporeal Shock Wave TherapyLow Intensity LaserPlantar Fasciitis

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    On the VAS (Visual Analogue Scale), pain intensity is usually rated from 0 for "no pain" to 10 for "the worst pain imaginable" (10 cm scale). Scoring intervals for pain intensity: \<3 mild pain, 3-6 moderate pain, \>6 severe pain. The VAS is a practical scale that is widely used in chronic pain worldwide. In this study it is evaluated as Visual Analog Scale-rest (VAS-I), Visual Analog Scale-first press (VAS-ib) and Visual Analog Scale-activity (VAS-a).

    Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)

Secondary Outcomes (3)

  • Foot Fonction Index

    Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)

  • Plantar Fascia Thickness Measurement with Ultrasound Imaging

    Before treatment (Week 0) and after treatment (Week 12)

  • Measurement of Balance Parameters in Biodex Balance Device

    Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)

Study Arms (3)

Extracorporeal Shock Wave Therapy Group

ACTIVE COMPARATOR

By the same physiotherapist with more than 5 years of clinical experience, radial ESWT treatment with 2500 pulses, 10 Hz frequency, 2.5-3 bar pressure, is applied to the most painful point of the heel and surrounding soft tissues, plantar aponeurosis and Achilles tendon insertion area on the dorsum of the heel, once a week for a total of 3 sessions. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks.

Other: Extracorporeal Shock Wave TherapyOther: EXERCİSE

Low Intensity Laser Group

ACTIVE COMPARATOR

A total of 28j (5.6jx5 points) are applied to the plantar fascia at 5 points on the heel by the same physiotherapist for 3 weeks, a total of 9 sessions (every other day) with the patient lying face down. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks.

Other: Low Intensity LaserOther: EXERCİSE

Exercise Group

PLACEBO COMPARATOR

Exercise therapy is carried out by the patient for 3 weeks. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks.

Other: EXERCİSE

Interventions

By the same physiotherapist with more than 5 years of clinical experience, radial ESWT treatment with 2500 pulses, 10 Hz frequency, 2.5-3 bar pressure, is applied to the most painful point of the heel and surrounding soft tissues, plantar aponeurosis and Achilles tendon insertion area on the dorsum of the heel, once a week for a total of 3 sessions.

Extracorporeal Shock Wave Therapy Group

A total of 28j (5.6jx5 points) are applied to the plantar fascia at 5 points on the heel by the same physiotherapist for 3 weeks, a total of 9 sessions (every other day) with the patient lying face down.

Low Intensity Laser Group

Exercise therapy is carried out by the patient for 3 weeks. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks.

Exercise GroupExtracorporeal Shock Wave Therapy GroupLow Intensity Laser Group

Eligibility Criteria

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

You may qualify if:

  • Male and female patients between 18 and 65 years of age, diagnosed with "plantar fasciitis" by anamnesis and physical examination
  • Complaint duration of at least 3 months
  • Patients who agree to participate in the study

You may not qualify if:

  • Complaint lasting less than 3 months
  • Injection in the heel area in the last 6 months
  • Use of physiotherapy modalities for the heel in the last 6 months
  • Bilateral complaint
  • Pregnancy
  • Malignancy
  • Epilepsy
  • History of cardiac pacemaker
  • Anticoagulant use
  • History of systemic inflammatory disease
  • History of lower extremity fracture or surgery
  • Existing open wound in the heel area
  • Patient hypersensitivity
  • Systemic infection in the patient
  • Uncontrolled hypertension in the patient
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Kirşehi̇r, 40100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Extracorporeal Shockwave TherapyExercise Therapy

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationAftercareContinuity of Patient CarePatient Care

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups with a exercise control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 26, 2025

Study Start

March 7, 2025

Primary Completion

December 25, 2025

Study Completion

December 25, 2025

Last Updated

December 31, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations