Plantar FasciitisNCT07204210
Comparison of Treatment Efficacy of Extracorporeal Shockwave Therapy (ESWT) and Myofascial Release Techniques in Patients With Plantar Fasciitis
A study testing extracorporeal shockwave therapy and myofascial release technique in people with Plantar Fasciitis, run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- extracorporeal shockwave therapy and myofascial release technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Being tested
- extracorporeal shockwave therapy, myofascial release technique, Placebo Control
- Keywords
- plantar fascitis, heel pain, myofascial release, eswt, heel spur
- Medical subject headings
- Fasciitis, Plantar, Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shockwave therapyDevice
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 techniqueOther
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.
Placebo ControlOther
Participants were not given any interventions that had proven effective for treatment. An appointment was made for 5 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: pre-treatment, 1st week post-treatment and 6th week post-treatment
Secondary outcomes (1)
Roles and Maudsley pain score
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.
Measured: pre-treatment, 1st week post-treatment and 6th week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start15 Sep 2025
- Primary completion27 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Rumeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak YİGİT, Istanbul Rumeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204210
- Sponsor's protocol ID
- IRU-FTR-BY-01
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Efficacy of Extracorporeal Shockwave Therapy (ESWT) and Myofascial Release Techniques in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT07204210
- Acronym / sponsor ID
- IRU-FTR-BY-01
- Conditions
- Plantar Fasciitis
- Keywords
- plantar fascitis, heel pain, myofascial release, eswt, heel spur
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Istanbul Rumeli UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 27 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESWT treatment group | Experimental | Device: extracorporeal shockwave therapyPatients 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. |
| myofascial release treatment group | Experimental | Other: myofascial release techniqueMyofascial 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 |
| control group | Placebo comparator | Other: Placebo ControlControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Obvious major foot trauma
- Pregnancy
- Presence of tumor
- Coagulation disorder
- Presence of open wounds and extreme sensitivity in the foot area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extracorporeal shockwave therapyExtracorporeal 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. | Device | ESWT treatment group |
| myofascial release techniqueMyofascial 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. | Other | myofascial release treatment group |
| Placebo ControlParticipants were not given any interventions that had proven effective for treatment. An appointment was made for 5 weeks later. | Other | control group |
Primary outcome
American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AHFS)
Time frame: 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)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Roles and Maudsley pain score
Time frame: pre-treatment, 1st week post-treatment and 6th week post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal shockwave therapy and myofascial release technique in people with Plantar Fasciitis, run by Istanbul Rumeli University at 1 site 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 5 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AHFS) (time frame: pre-treatment, 1st week post-treatment and 6th week post-treatment). The study lists 3 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 2 Oct 2025.