Plantar FascitisNCT07471035
Focused Shockwave Therapy for Plantar Fasciopathy
A study testing fESWT in people with Plantar Fascitis and Chronic Plantar Fasciitis, run by Sierra Varona SL.
Trial summary
This study investigates whether focused Extracorporeal Shockwave Therapy (fESWT) helps people with chronic heel pain, commonly known as plantar fasciitis. Many patients suffer from this condition for more than six months without relief. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plantar Fascitis, Chronic Plantar Fasciitis, Fasciitis
- What is being tested?
- fESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 30 Jun 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged between 18 and 70 years. Diagnosis of chronic plantar fasciopathy with symptoms persisting for more than 6 months.
- Presence of plantar fascia (PF) thickness > 4.0 mm, confirmed by high-resolution ultrasound.
- Clinical history of localized pain at the medial calcaneal tubercle, specifically upon first steps in the morning or after prolonged rest.
- Failure of previous conservative treatments (e.g., stretching, orthotics, or medication).
- Ability to follow the High-Load Strength Training (HLST) exercise protocol.
Who cannot join
- Previous treatment with shockwave therapy or corticosteroid injections in the affected foot within the last 6 months.
- Previous surgery for plantar heel pain.
- Presence of systemic inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis).
- Pregnancy.
- Coagulopathies or use of anticoagulant medication.
- Local infection or presence of skin lesions at the application site.
- Known or suspected malignancy in the treatment area.
- Presence of neurological conditions or peripheral neuropathy (e.g., tarsal tunnel syndrome).
About this study
Official title: Focused ESWT vs. Wait-list Management for Plantar Fasciopathy: A Randomized Controlled Trial Evaluating Pain, Function, and Ultrasonographic Plantar Fascia Thickness
This study investigates whether focused Extracorporeal Shockwave Therapy (fESWT) helps people with chronic heel pain, commonly known as plantar fasciitis. Many patients suffer from this condition for more than six months without relief.
The study compares two groups: one receiving fESWT treatment plus a specific exercise program, and a "wait-list" group that only performs the exercises at first. The shockwave treatment uses precise sound waves targeted at the painful area to stimulate the body's natural healing process.
Researchers will measure if the treatment reduces pain and improves the patient's ability to walk and perform daily activities. Additionally, ultrasound will be used to see if the thickness of the plantar fascia (the tissue under the foot) decreases and returns to a healthier state. The goal is to confirm if fESWT provides a faster and more effective recovery than exercise alone.
Read the detailed description
This is a prospective, randomized, wait-list controlled pilot study designed to evaluate the clinical and structural effects of focused Extracorporeal Shockwave Therapy (fESWT) on chronic plantar fasciopathy.Study Design and Participants:Twenty participants with chronic plantar heel pain lasting more than six months were enrolled. Inclusion criteria required a diagnosis of plantar fasciopathy confirmed by a thickness of > 4.0 mm on ultrasound. Participants were randomized 1:1 into an Experimental Group (fESWT + High-Load Strength Training) or a Wait-list Control Group (High-Load Strength Training only).Intervention Protocol:fESWT Administration: The experimental group received three sessions of fESWT once per week. Each session consisted of 2,000 pulses at a frequency of 5-8 Hz.Energy Settings: The Energy Flux Density (EFD) was titrated based on patient tolerance, ranging from 0.10 to 0.30 mJ/mm^2, using a "point-and-shoot" technique at the site of maximal tenderness.Standard of Care: All participants followed a progressive High-Load Strength Training (HLST) protocol, performing heel raises every other day.Assessments and Follow-up:The primary outcome measures include pain intensity via the Visual Analogue Scale (VAS) and functional disability via the Foot Function Index (FFI). Secondary outcomes focus on structural remodeling of the plantar fascia measured by high-resolution ultrasound. Evaluations are conducted at baseline and at 4, 8, and 12 weeks post-intervention to track both immediate rescue effects and long-term tissue normalization.Wait-list Management:To maintain ethical standards, the wait-list control group received the fESWT intervention after the initial 4-week comparative period.
- Conditions
- Plantar Fascitis, Chronic Plantar Fasciitis, Fasciitis
- Being tested
- fESWT, Wait-list Control: Exercise Only
- Keywords
- FOCUSED SHOCK WAVE THERAPY, fESWT, PLANTAR FASCIA THICKNESS
- Medical subject headings
- Fasciitis, Plantar, Fasciitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fESWTDevice
Three weekly sessions of focused shockwave therapy. Each session consists of 2,000 pulses at a frequency of 5-8 Hz. The Energy Flux Density (EFD) is titrated between 0.10 and 0.30 mJ/mm2 based on patient tolerance. The "point-and-shoot" technique is applied to the site of maximal tenderness.
Wait-list Control: Exercise OnlyOther
Participants assigned to this arm will undergo a wait-list period of 4 weeks during which they only perform the standardized High-Load Strength Training (HLST) program. The HLST consists of progressive unilateral heel-rise exercises performed every other day. This group serves as a comparative control to assess the clinical and structural changes (plantar fascia thickness) without the addition of shockwave therapy during the initial phase. After the primary 4-week assessment is completed, participants in this arm are offered the same focused Extracorporeal Shockwave Therapy (fESWT) protocol as the experimental group for ethical reasons.
| Study group | Role | What they receive |
|---|---|---|
| fESWT | Experimental | Participants in this arm receive three weekly sessions of focused Extracorporeal Shockwave Therapy (fESWT). The treatment consists of 2,000 pulses per session with an Energy Flux Density (EFD) titrated to patient tolerance (ranging from 0.10 to 0.30 mJ/mm2) at a frequency of 5-8 Hz. Receives: Device: fESWT; Other: Wait-list Control: Exercise Only |
| Wait-list Control: Exercise Only | Other | Participants in this wait-list control arm perform only the standardized High-Load Strength Training (HLST) program (progressive heel-rises every other day) during the initial 4-week comparative phase. This arm serves as the control group to evaluate the specific clinical and structural added value of fESWT. For ethical reasons, after the primary 4-week assessment is completed, these participants are offered the same fESWT protocol administered to the experimental group. Receives: Other: Wait-list Control: Exercise Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Pain intensity will be measured using a 100-cm Visual Analogue Scale, where 0 represents "no pain" and 10 represents "the worst pain imaginable." A higher score indicates greater pain intensity.
Measured: baseline,4,8 and 12 weeks
Plantar Fascia (PF) Thickness
The thickness of the plantar fascia will be measured in millimeters (mm) using high-resolution B-mode ultrasound. Measurements are taken approximately 1 cm distal to the calcaneal insertion. A decrease in thickness is associated with tissue remodeling and clinical recovery.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks.
Secondary outcomes (1)
Foot Function Index (FFI) Score
The Foot Function Index (FFI) is a self-administered questionnaire used to measure foot pain and disability. The score is expressed as a percentage (0-100%), where higher percentages indicate greater disability and worse foot health.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies 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
- Model description
- This is a prospective, randomized, wait-list controlled pilot study utilizing a parallel assignment model. Participants are randomized into two groups to compare the clinical and structural effects of focused Extracorporeal Shockwave Therapy (fESWT) against a control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sierra Varona SL
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471035
- Sponsor's protocol ID
- 23
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused ESWT vs. Wait-list Management for Plantar Fasciopathy: A Randomized Controlled Trial Evaluating Pain, Function, and Ultrasonographic Plantar Fascia Thickness
- ClinicalTrials.gov ID
- NCT07471035
- Acronym / sponsor ID
- 23
- Conditions
- Plantar Fascitis, Chronic Plantar Fasciitis, Fasciitis
- Keywords
- FOCUSED SHOCK WAVE THERAPY, fESWT, PLANTAR FASCIA THICKNESS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sierra Varona SLUniversity, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Mar 2026 (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.
This study investigates whether focused Extracorporeal Shockwave Therapy (fESWT) helps people with chronic heel pain, commonly known as plantar fasciitis. Many patients suffer from this condition for more than six months without relief.
The study compares two groups: one receiving fESWT treatment plus a specific exercise program, and a "wait-list" group that only performs the exercises at first. The shockwave treatment uses precise sound waves targeted at the painful area to stimulate the body's natural healing process.
Researchers will measure if the treatment reduces pain and improves the patient's ability to walk and perform daily activities. Additionally, ultrasound will be used to see if the thickness of the plantar fascia (the tissue under the foot) decreases and returns to a healthier state. The goal is to confirm if fESWT provides a faster and more effective recovery than exercise alone.
Detailed description
This is a prospective, randomized, wait-list controlled pilot study designed to evaluate the clinical and structural effects of focused Extracorporeal Shockwave Therapy (fESWT) on chronic plantar fasciopathy.Study Design and Participants:Twenty participants with chronic plantar heel pain lasting more than six months were enrolled. Inclusion criteria required a diagnosis of plantar fasciopathy confirmed by a thickness of > 4.0 mm on ultrasound. Participants were randomized 1:1 into an Experimental Group (fESWT + High-Load Strength Training) or a Wait-list Control Group (High-Load Strength Training only).Intervention Protocol:fESWT Administration: The experimental group received three sessions of fESWT once per week. Each session consisted of 2,000 pulses at a frequency of 5-8 Hz.Energy Settings: The Energy Flux Density (EFD) was titrated based on patient tolerance, ranging from 0.10 to 0.30 mJ/mm^2, using a "point-and-shoot" technique at the site of maximal tenderness.Standard of Care: All participants followed a progressive High-Load Strength Training (HLST) protocol, performing heel raises every other day.Assessments and Follow-up:The primary outcome measures include pain intensity via the Visual Analogue Scale (VAS) and functional disability via the Foot Function Index (FFI). Secondary outcomes focus on structural remodeling of the plantar fascia measured by high-resolution ultrasound. Evaluations are conducted at baseline and at 4, 8, and 12 weeks post-intervention to track both immediate rescue effects and long-term tissue normalization.Wait-list Management:To maintain ethical standards, the wait-list control group received the fESWT intervention after the initial 4-week comparative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, wait-list controlled pilot study utilizing a parallel assignment model. Participants are randomized into two groups to compare the clinical and structural effects of focused Extracorporeal Shockwave Therapy (fESWT) against a control group.
| Arm | Type | Receives |
|---|---|---|
| fESWT | Experimental | Device: fESWT, Other: Wait-list Control: Exercise OnlyParticipants in this arm receive three weekly sessions of focused Extracorporeal Shockwave Therapy (fESWT). The treatment consists of 2,000 pulses per session with an Energy Flux Density (EFD) titrated to patient tolerance (ranging from 0.10 to 0.30 mJ/mm2) at a frequency of 5-8 Hz. |
| Wait-list Control: Exercise Only | Other | Other: Wait-list Control: Exercise OnlyParticipants in this wait-list control arm perform only the standardized High-Load Strength Training (HLST) program (progressive heel-rises every other day) during the initial 4-week comparative phase. This arm serves as the control group to evaluate the specific clinical and structural added value of fESWT. For ethical reasons, after the primary 4-week assessment is completed, these participants are offered the same fESWT protocol administered to the experimental group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged between 18 and 70 years. Diagnosis of chronic plantar fasciopathy with symptoms persisting for more than 6 months.
- Presence of plantar fascia (PF) thickness > 4.0 mm, confirmed by high-resolution ultrasound.
- Clinical history of localized pain at the medial calcaneal tubercle, specifically upon first steps in the morning or after prolonged rest.
- Failure of previous conservative treatments (e.g., stretching, orthotics, or medication).
- Ability to follow the High-Load Strength Training (HLST) exercise protocol.
Key exclusion criteria (8 listed)
- Previous treatment with shockwave therapy or corticosteroid injections in the affected foot within the last 6 months.
- Previous surgery for plantar heel pain.
- Presence of systemic inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis).
- Pregnancy.
- Coagulopathies or use of anticoagulant medication.
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 |
|---|---|---|
| fESWTThree weekly sessions of focused shockwave therapy. Each session consists of 2,000 pulses at a frequency of 5-8 Hz. The Energy Flux Density (EFD) is titrated between 0.10 and 0.30 mJ/mm2 based on patient tolerance. The "point-and-shoot" technique is applied to the site of maximal tenderness. | Device | fESWT |
| Wait-list Control: Exercise OnlyParticipants assigned to this arm will undergo a wait-list period of 4 weeks during which they only perform the standardized High-Load Strength Training (HLST) program. The HLST consists of progressive unilateral heel-rise exercises performed every other day. This group serves as a comparative control to assess the clinical and structural changes (plantar fascia thickness) without the addition of shockwave therapy during the initial phase. After the primary 4-week assessment is completed, participants in this arm are offered the same focused Extracorporeal Shockwave Therapy (fESWT) protocol as the experimental group for ethical reasons. | Other | Wait-list Control: Exercise Only, fESWT |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: baseline,4,8 and 12 weeks
Pain intensity will be measured using a 100-cm Visual Analogue Scale, where 0 represents "no pain" and 10 represents "the worst pain imaginable." A higher score indicates greater pain intensity.
Plantar Fascia (PF) Thickness
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks.
The thickness of the plantar fascia will be measured in millimeters (mm) using high-resolution B-mode ultrasound. Measurements are taken approximately 1 cm distal to the calcaneal insertion. A decrease in thickness is associated with tissue remodeling and clinical recovery.
1 secondary outcome
Foot Function Index (FFI) Score
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks.
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 20 Mar 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing fESWT in people with Plantar Fascitis and Chronic Plantar Fasciitis, run by Sierra Varona SL.
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: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Visual Analogue Scale (VAS) (time frame: baseline,4,8 and 12 weeks). The study lists 2 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 20 Mar 2026.