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

Not Applicable

• Conditions: Plantar Fasciitis

• Registration Number: NCT07204210
• Lead Sponsor: Istanbul Rumeli University

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.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-15
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2025-10-27
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AHFS)	pre-treatment, 1st week post-treatment and 6th week post-treatment	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.
Foot Function İndex (FFİ)	pre-treatment, 1st week post-treatment and 6th week post-treatment	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.
Visual Analog Scale (VAS)	pre-treatment, 1st week post-treatment and 6th week post-treatment	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.

Secondary Outcome Measures

Name	Time	Method
Roles and Maudsley pain score	pre-treatment, 1st week post-treatment and 6th week post-treatment	The Roles and Maudsley pain scoring is a method used to assess pain level and range of motion. This score is divided into four categories: Excellent (1 Point): No pain, full range of motion, and activity. Good (2 Points): Occasional discomfort, full range of motion, and activity. Fair (3 Points): Some pain after prolonged activity. Poor (4 Points): Pain that limits activities.

Trial Locations

Locations (1)

Kayseri City Hospital; Kayseri, Turkey (Türkiye)