Comparison of Treatment Efficacy of Extracorporeal Shockwave Therapy (ESWT) and Myofascial Release Techniques in Patients With Plantar Fasciitis

NCT ID: NCT07204210

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2025-12-31

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.

Detailed Description

The present study aims to compare the effectiveness of extracorporeal shock wave therapy (ESWT), a frequently used treatment for patients with plantar fasciitis and heel pain, with specific myofascial release techniques. The paucity of studies in the literature and the lack of definitive evidence on this topic served as the basis for initiating this research. A total of 114 patients diagnosed with plantar fasciitis, deemed appropriate for ESWT and myofascial release therapy and meeting the inclusion criteria, are planned to participate in the study. These 114 patients will be randomly divided into three groups of 38 each. Before and after treatment, each patient will complete a demographic data form, the Visual Analog Scale (VAS), the Foot Function Index (FFI), the Roles and Maudsley pain scores, and the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot clinical assessment scales. Participants will be randomly selected from among individuals who applied to Kayseri City Hospital with complaints of plantar fasciitis within the Kayseri province. The three groups will consist of a myofascial release treatment group, an ESWT treatment group, and a control group. The ESWT group will receive 2,000 pulses per session at 2.0 bar intensity, 14 Hz frequency, and a dose of 0.2 mJ/mm². Specific myofascial release techniques will be administered to the myofascial release group once per week for 16 minutes, over a total period of 5 weeks. No treatment will be administered to the control group. An evaluation appointment will be scheduled 5 weeks after baseline data collection using the designated assessment tools. Pre-treatment and post-treatment data for all three groups will be recorded using the SPSS software. After data collection is completed, appropriate statistical analyses will be conducted.

Conditions

Plantar Fasciitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ESWT treatment group

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.

Group Type: EXPERIMENTAL

extracorporeal shockwave therapy

Intervention Type: DEVICE

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.

myofascial release treatment group

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

Group Type: EXPERIMENTAL

myofascial release technique

Intervention Type: OTHER

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.

control group

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.

Group Type: PLACEBO_COMPARATOR

Placebo Control

Intervention Type: OTHER

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

Interventions

extracorporeal shockwave therapy

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.

Intervention Type: DEVICE

myofascial release technique

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.

Intervention Type: OTHER

Placebo Control

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Rumeli University

OTHER

Sponsor Role: lead

Responsible Party

Burak YİGİT

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kayseri City Hospital

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IRU-FTR-BY-01

Identifier Type: -

Identifier Source: org_study_id