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Plantar Fasciitis of Both FeetNCT06890806

Foot Core Stabilization Exercises vs. Shockwave Therapy for Pain, Strength, and Function in Plantar Fasciitis

A study testing Foot Core Stabilization Exercise Group (FCSEG) and Extracorporeal Shock Wave Therapy Group (ESWTG) in people with Plantar Fasciitis of Both Feet, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled trial was designed to compare the effects of foot core stabilization exercises (FCSE) and extracorporeal shock wave therapy (ESWT) on pain intensity, muscle strength, foot posture, medial longitudinal arch height, lower extremity alignment, and foot function in individuals with plantar… Read more about this study

Who is it for?
Ages 25 to 60 years
Conditions the study is for
Plantar Fasciitis of Both Feet
What is being tested?
Foot Core Stabilization Exercise Group (FCSEG) and Extracorporeal Shock Wave Therapy Group (ESWTG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Mar 2025to 30 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adults aged 25-60 years with a diagnosis of plantar fasciitis confirmed by an orthopedic physician.
  • Heel pain localized to the medial calcaneal tubercle persisting for at least three months.

Who cannot join

  • History of foot or ankle surgery.
  • Chronic or active infection in the treatment area.
  • Type 1 or Type 2 diabetes mellitus, systemic inflammatory arthritis, cancer, active tuberculosis, or neurological or vascular diseases.
  • Previous conservative treatments, including nonsteroidal anti-inflammatory drugs, that were ineffective for at least six months.
  • Provoked or non-provoked numbness or tingling in the lower extremity or undiagnosed pain.
  • Pregnancy.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Mudanya University

    Bursa, Bursa, 16160

  • Medicalpark Hospital

    Bursa

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effects of Foot Core Stabilization Exercises and Extracorporeal Shock Wave Therapy on Pain, Muscle Strength, and Function in Individuals With Plantar Fasciitis: A Randomized Controlled Trial

This randomized controlled trial was designed to compare the effects of foot core stabilization exercises (FCSE) and extracorporeal shock wave therapy (ESWT) on pain intensity, muscle strength, foot posture, medial longitudinal arch height, lower extremity alignment, and foot function in individuals with plantar fasciitis (PF).

A total of 43 participants were randomized into two intervention groups, and 40 participants completed the study and were included in the final analysis (FCSE: n=20; ESWT: n=20). The FCSE group performed supervised foot core stabilization exercises three times per week for five weeks, while the ESWT group received treatment once per week for five weeks.

Read more

The primary outcomes were pain intensity, assessed using the Visual Analog Scale (VAS), and foot function, assessed using the Foot Function Index (FFI). Secondary outcomes included ankle dorsiflexor and plantar flexor muscle strength, navicular drop, quadriceps (Q) angle, and foot posture assessed using the Foot Posture Index (FPI). All outcomes were evaluated before and after the five-week intervention period.

The study aimed to provide evidence regarding the comparative effectiveness of these two conservative treatment approaches in the rehabilitation of individuals with plantar fasciitis.

Read the detailed description

This prospective, randomized controlled trial compared the effects of foot core stabilization exercises (FCSE) and extracorporeal shock wave therapy (ESWT) on pain intensity, muscle strength, foot posture, and functional outcomes in individuals with plantar fasciitis (PF).

A total of 43 participants aged 25-60 years with plantar fasciitis were randomized into two intervention groups using a computer-generated randomization sequence. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes. Three participants discontinued treatment, and 40 participants completed the study and were included in the final analysis (FCSE: n=20; ESWT: n=20).

The primary outcomes were heel pain intensity, assessed using the Visual Analog Scale (VAS), and foot function, assessed using the Foot Function Index (FFI). Secondary outcomes included ankle dorsiflexor and plantar flexor muscle strength measured using a Kinvent K-Force dynamometer, medial longitudinal arch height assessed using the Navicular Drop Test, lower extremity alignment evaluated using the Quadriceps (Q) Angle, and foot posture assessed using the Foot Posture Index (FPI).

The FCSE group performed a supervised exercise program consisting of short foot exercises, towel curls, big toe presses, toe splay exercises, calf raises with big toe presses, leg swings, and backward tandem walking. Exercise sessions lasted 40 minutes and were conducted three times weekly for five weeks.

The ESWT group received treatment using the Gymna ShockMaster 500 device at a frequency of 15 Hz and a pressure of 3 bar, with 1,800 impulses delivered per session. Treatment was administered once weekly for five weeks.

All assessments were performed before and after the intervention period by the same experienced physiotherapist, who was blinded to group allocation.

The study aimed to evaluate the comparative effectiveness of these two conservative rehabilitation approaches in individuals with plantar fasciitis.

Being tested
Foot Core Stabilization Exercise Group (FCSEG), Extracorporeal Shock Wave Therapy Group (ESWTG)
Keywords
Extracorporeal Shock Wave Therapy, Pain, Foot stabilization exercises
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foot Core Stabilization Exercise Group (FCSEG)Other

    Participants in the Foot Core Stabilization Exercise Group (FCSEG) performed a supervised exercise program consisting of seven exercises: short foot exercise, towel curl exercise, big toe press exercise, toe splay exercise, calf raise to big toe press exercise, leg swing exercise, and backward tandem walking. The exercises were performed for 40 minutes per session, three times per week for five consecutive weeks under the supervision of a physiotherapist. Each exercise was performed according to the standardized protocol, with 15 repetitions for the specified exercises. The exercise intensity and difficulty remained unchanged throughout the intervention period.

  • Extracorporeal Shock Wave Therapy Group (ESWTG)Other

    Participants in the Extracorporeal Shock Wave Therapy Group (ESWTG) received ESWT using the Gymna ShockMaster 500 device with a 12-mm applicator. Treatment was administered in continuous mode at a frequency of 15 Hz and a pressure of 3 bar, delivering a total of 1,800 impulses per session. ESWT was applied to multiple painful points in the heel region, including the central and medial aspects, by a trained physiotherapist. Treatment was administered once weekly for five consecutive weeks.

Study groups in NCT06890806
Study groupRoleWhat they receive
Foot Core Stabilization Exercise Group (FCSEG)ExperimentalFoot Core Stabilization Exercise Group (FCSEG)
Receives: Other: Foot Core Stabilization Exercise Group (FCSEG)
Extracorporeal Shock Wave Therapy Group (ESWTG)ExperimentalExtracorporeal Shock Wave Therapy Group (ESWTG)
Receives: Other: Extracorporeal Shock Wave Therapy Group (ESWTG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heel Pain Intensity Assessed Using the Visual Analog Scale (VAS)

    Heel pain intensity was assessed using the Visual Analog Scale (VAS). Participants indicated their pain intensity on a 10-cm horizontal scale, where 0 represented no pain and 10 represented severe pain. Higher scores indicated greater pain intensity.

    Measured: Baseline and post-intervention (at the end of week 5)

  2. Medial Longitudinal Arch Height Assessed Using the Navicular Drop Test

    The Navicular Drop Test will be used to assess participants' MLA height. Before measurements, the navicular tubercle will be marked while the individual stands barefoot. First, the distance between the navicular tubercle and the ground will be measured in millimeters while seated with the foot unloaded. Then, the individual will stand and bear full weight, and the new distance will be recorded. The difference between these two measurements will be calculated. Results will be classified as increased supination (<5mm), neutral foot (5-9mm), and increased pronation (>9mm).

    Measured: Baseline and post-intervention (at the end of week 5)

  3. Ankle Dorsiflexor and Plantar Flexor Muscle Strength (kg)

    Ankle dorsiflexor and plantar flexor muscle strength was assessed using a Kinvent K-Force digital dynamometer. Participants were positioned supine during testing. For dorsiflexor strength assessment, the dynamometer was placed over the dorsal metatarsal region, while for plantar flexor strength assessment, it was positioned under the plantar metatarsal region. Participants were instructed to exert maximal force against the device. Three maximal voluntary isometric contractions were performed for each muscle group, and the highest recorded force value was used for statistical analysis. Muscle strength was expressed in kilograms (kg).

    Measured: Baseline and post-intervention (at the end of week 5)

  4. Quadriceps (Q) Angle Measurement (Degrees)

    The quadriceps (Q) angle was measured using a plastic goniometer to evaluate lower extremity alignment. Participants were positioned supine with their knees fully extended. The pivot point of the goniometer was placed at the center of the patella, the stationary arm was aligned with the tibial tuberosity, and the moving arm was directed toward the anterior superior iliac spine. The angle formed between the two arms was recorded in degrees (°).

    Measured: Baseline and post-intervention (at the end of week 5)

Secondary outcomes (2)
  1. Foot Posture Assessed Using the Foot Posture Index (FPI)

    Foot posture will be assessed using the Foot Posture Index (FPI). Individuals with PF will stand in a relaxed position, looking forward, with arms at their sides, maintaining body alignment.

    FPI includes six clinical criteria:

    • Talar head palpation
    • Curvatures above and below the lateral malleolus
    • Calcaneal inversion/eversion
    • Bulging in the talonavicular joint
    • MLA structure
    • Forefoot abduction/adduction relative to the rearfoot

    Each criterion is scored from -2 to +2, and the total score is recorded. A score of 0 indicates a neutral foot, positive values indicate pronation, and negative values indicate supination.

    Measured: Baseline and post-intervention (at the end of week 5)

  2. Foot Function Assessed Using the Foot Function Index (FFI)

    Foot function was assessed using the Foot Function Index (FFI), a 23-item questionnaire consisting of three subscales: pain, disability, and activity limitation. The pain subscale evaluates foot pain experienced in different situations, the disability subscale assesses difficulties in performing functional activities, and the activity limitation subscale evaluates restrictions in daily activities due to foot problems. Participants rated each item based on their foot condition during the preceding week using a Visual Analog Scale (VAS) scoring system. Higher FFI scores indicate greater foot-related pain, disability, and functional limitation.

    Measured: Baseline and post-intervention (at the end of week 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start1 Mar 2025
  3. Primary completion1 Jun 2025
  4. Study completion30 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study employed a randomized, parallel-group design. Participants were randomly allocated to two intervention groups using a computer-generated randomization sequence, with allocation concealment ensured through sequentially numbered, opaque, sealed envelopes. The Foot Core Stabilization Exercise Group (FCSEG) received supervised foot core stabilization exercises three times weekly for five weeks, while the Extracorporeal Shock Wave Therapy Group (ESWTG) received ESWT once weekly for five weeks.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06890806
Sponsor's protocol ID
E-10840098-202.3.02-7450
Status last verified
Mar 2025
First submitted
11 Mar 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Foot Core Stabilization Exercise Group (FCSEG) and Extracorporeal Shock Wave Therapy Group (ESWTG) in people with Plantar Fasciitis of Both Feet, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heel Pain Intensity Assessed Using the Visual Analog Scale (VAS) (time frame: Baseline and post-intervention (at the end of week 5)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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