NCT07204210

Brief Summary

Various treatment methods are employed for patients diagnosed with plantar fasciitis. However, many of these approaches involve high-cost interventions, such as extracorporeal shock wave therapy (ESWT) and platelet-rich plasma (PRP) applications. The present study aims to compare the treatment effectiveness of myofascial release-considered a cost-effective intervention-with ESWT, which is among the most commonly preferred treatment modalities.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

September 15, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

September 17, 2025

Last Update Submit

September 24, 2025

Conditions

Keywords

plantar fascitisheel painmyofascial releaseeswtheel spur

Outcome Measures

Primary Outcomes (3)

  • American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AHFS)

    The AOFAS-hindfoot clinical assessment system grades the ankle, subtalar, talonavicular, and calcaneocuboid joint levels. A patient can receive a score of 100 if they have no pain, full sagittal and hindfoot range of motion, no instability in the ankle or hindfoot, good alignment, the ability to walk more than six blocks, the ability to walk on any walking surface, no noticeable limp, no limitations in daily or recreational activities, and no need for assistive devices for ambulation. The scale includes 50 points for function, 40 points for pain, and 10 points for alignment. Increasing scores indicate that the patient's condition is good.

    pre-treatment, 1st week post-treatment and 6th week post-treatment

  • Foot Function İndex (FFİ)

    447 / 5.000 The Foot Function Index (FFI) is a questionnaire that assesses multiple dimensions of foot function. The FFI consists of 23 items divided into three subscales that measure the impact of foot pathology on pain, disability, and activity limitation. The Foot Function Index is widely used in various pathologies and treatments related to foot and ankle problems, including congenital, acute, and chronic diseases, injuries, and surgical procedures. Increasing scores indicate that the patient's condition is good.

    pre-treatment, 1st week post-treatment and 6th week post-treatment

  • Visual Analog Scale (VAS)

    This scale was created to assess the severity of pain in patients. Patients will be asked to rate their heel and sole pain on a scale of 1 to 10. 10 represents severe, function-limiting, and unbearable pain, while 0 represents no pain at all.

    pre-treatment, 1st week post-treatment and 6th week post-treatment

Secondary Outcomes (1)

  • Roles and Maudsley pain score

    pre-treatment, 1st week post-treatment and 6th week post-treatment

Study Arms (3)

ESWT treatment group

EXPERIMENTAL

Patients in the ESWT group will receive a total of five sessions of ESWT, once a week for five weeks. The ESWT group will receive 2000 pulses per session at 14 Hz, 2.0 barr intensity, and a dose of 0.2 mJ/mm2. ESWT will be applied primarily to areas near the calcaneal insertion of the plantar fascia.

Device: extracorporeal shockwave therapy

myofascial release treatment group

EXPERIMENTAL

Myofascial Release treatment group patients will receive treatments once a week for 5 weeks, for a total of 5 weeks. Treatments will be applied once a week for 5 weeks. The following will be applied for a total of 16 minutes: 2 minutes of constant pressure with the therapist's two thumbs to the center of the central part of the plantar fascia and the calcaneal insertion point; 2 minutes of constant pressure with the therapist's thumb to the lateral and medial parts of the plantar fascia, along the line, progressing anteriorly as the fascial tissue relaxes; 2 minutes of constant pressure with the therapist's thumb to the gastrocnemius muscle at its most swollen or taut point, progressing from caudal to cranial with constant pressure from the caudal to cranial point as the tissue relaxes; 2 minutes of constant pressure with the therapist's fist to the central tendon of the plantar fascia; and 2 minutes of constant pressure with the therapist's fist to the gastrocnemius muscle, from caud

Other: myofascial release technique

control group

PLACEBO COMPARATOR

Control group patients will not receive any treatment. After the data used in the study is collected, an appointment will be scheduled for five weeks later for comparison. Data will be collected and recorded again after five weeks.

Other: Placebo Control

Interventions

Extracorporeal shockwave therapy (ESWT) is a treatment using powerful acoustic pulses which is mostly used to treat kidney stones and in physical therapy and orthopedics. Extracorporeal shockwave therapy is used as a second line measure to treat tennis elbow, shoulder rotator cuff pain, Achilles tendinitis, plantar fasciitis, and greater trochanteric pain syndrome. The lithotripter attempts to break up the stone with minimal collateral damage by using an externally applied, focused, high-intensity acoustic pulse. The patient is usually sedated or anesthetized for the procedure in order to help them remain still and reduce possible discomfort.

ESWT treatment group

Myofascial release (MFR, self-myofascial release) is an alternative medicine therapy claimed to be useful for treating skeletal muscle immobility and pain by relaxing contracted muscles, improving blood and lymphatic circulation and stimulating the stretch reflex in muscles. Writing for Science-Based Medicine, Harriet Hall described myofascial release as an umbrella term for several types of physical manipulation, which might more simply be described as a kind of massage based on vaguely defined scientific notions. Reviews published in 2013 and 2015 evaluating evidence for MFR efficacy found that clinical trials that had been conducted varied in quality, technique, outcome measurements and had mixed outcomes; the 2015 review noted: "it is time for scientific evidences on MFR to support its clinical use.

myofascial release treatment group

Participants were not given any interventions that had proven effective for treatment. An appointment was made for 5 weeks later.

control group

Eligibility Criteria

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

You may qualify if:

  • Being over 18 years old
  • Being able to communicate in Turkish
  • Being able to read and write
  • Voluntarily agreeing to participate in the study
  • Having been diagnosed with plantar fasciitis

You may not qualify if:

  • Obvious major foot trauma
  • Pregnancy
  • Presence of tumor
  • Coagulation disorder
  • Presence of open wounds and extreme sensitivity in the foot area
  • Having had any surgical operation on the foot and ankle
  • Partial amputation of the foot
  • Application of one and/or more physical medicine modalities and corticosteroid injections within the last 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri City Hospital

Kayseri, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasciitis, PlantarHeel Spur

Interventions

Extracorporeal Shockwave TherapyMyofascial Release Therapy

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot DiseasesExostosesHyperostosisBone Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 17, 2025

First Posted

October 2, 2025

Study Start

September 15, 2025

Primary Completion

October 27, 2025

Study Completion

December 31, 2025

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations