Neuropathic PainPhase 2NCT07587255
Efficacy of Extracorporeal Shockwave Therapy on Plantar Fasciitis in Patients With Peripheral Neuropathy
A Phase 2 study testing Extracorporeal shockwave therapy (ESWT) in people with Neuropathic Pain and Plantar Fasciitis, run by National Taiwan University Hospital.
Trial summary
This study aims to evaluate the efficacy of extracorporeal shockwave therapy (ESWT) in reducing pain and improving functional outcomes for patients with neuropathy-associated plantar fasciitis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neuropathic Pain, Plantar Fasciitis
- What is being tested?
- Extracorporeal shockwave therapy (ESWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- May 2026to May 2032
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older and 90 or younger.
- Ability to give informed consent.
- Presence of peripheral neuropathy, confirmed by clinical symptoms, nerve
- conduction study, autonomic function test, quantitative sensory test, or skin biopsy.
- Plantar fasciitis presenting as (1) heel pain persisting for more than 3 months, most noticeable with initial steps after a period of inactivity, but also worse following prolonged weight-bearing, and (2) pain with palpation of the proximal insertion of the plantar fascia.
Who cannot join
- Presence of severe systemic diseases, including severe ischemic heart disease or congestive heart failure (left ventricular ejection fraction < 30%), severe lung diseases with dyspnea, severe generalized edema, uncontrolled diabetes, and systemic infection.
- Presence of severe peripheral vascular disease.
- Presence of an implanted cardiac pacemaker, deep brain stimulator, or metallic implants (for example, internal fixation plates, screws, etc.) within the affected foot or ankle.
- Presence of ruptured or pre-ruptured tendons in the target area. A diagnostic softtissue ultrasound of the plantar foot will be performed to assess tissue integrity if any of the following clinical red flags are identified: localized soft-tissue swelling or ecchymosis; physical examination findings indicative of a loss of continuity or tension in the plantar fascia; a history of local corticosteroid injection within the past 12 months; or a history of surgical intervention involving the affected foot.
- Complete loss of vibration and pinprick sensation at the target area due to neuropathy, or the presence of severe mechanical allodynia (pain evoked by friction or pressure) at the target area with an intensity score of 8 or higher on the Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents the most severe pain.
- Pregnancy.
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- Coagulation disorders (including localized thrombosis in the target area).
- Patients currently receiving anticoagulant therapy.
- Presence of localized tumors or active bacterial and/or viral infections in the target area.
- Patients who have received corticosteroid injections within the past 6 weeks in the target area.
- Inability to give informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Extracorporeal Shockwave Therapy for Plantar Fasciitis in Patients With Peripheral Neuropathy: A Clinical Evaluation
This study aims to evaluate the efficacy of extracorporeal shockwave therapy (ESWT) in reducing pain and improving functional outcomes for patients with neuropathy-associated plantar fasciitis.
Read the detailed description
Plantar fasciitis is the most common cause of heel pain in clinical practice, accounting for approximately 80% of patients presenting with heel pain. Common clinical presentations include unilateral or bilateral foot pain, particularly upon weight-bearing after a period of rest, such as the first steps in the morning. Some patients may also report associated paresthesia, tingling, or a burning sensation. Notably, a considerable number of patients with peripheral neuropathy (PN) also present with coexisting plantar fasciitis. The proposed pathophysiological mechanisms underlying neuropathy-associated plantar fasciitis include progressive degeneration of the plantar fascia due to chronic somatosensory deficits, thickening of the plantar fascia secondary to metabolic syndromes such as diabetic neuropathy, and the loss of foot intrinsic muscle support due to motor nerve involvement. Conventional treatments for plantar fasciitis include nonsteroidal anti-inflammatory drugs (NSAIDs), local corticosteroid injections, and custom orthotics; however, these interventions exhibit significant limitations. While NSAIDs may provide temporary analgesia, their long-term utility is limited by systemic risks, particularly gastrointestinal complications. Local corticosteroid injections effectively reduce inflammation and provide acute symptom relief; however, they carry a risk of plantar fascia rupture, rendering repeated administration clinically unfavorable. Orthotic insoles redistribute biomechanical loading across the foot to reduce mechanical stress; however, they are primarily compensatory and do not facilitate tissue regeneration or fundamental repair of the chronic lesion. Given these limitations in conventional treatments, this study aims to evaluate the efficacy of extracorporeal shockwave therapy (ESWT) in reducing pain and improving functional outcomes for patients with neuropathy-associated plantar fasciitis. The investigators will assess the effects of ESWT on the pathophysiological mechanism of the neuropathic foot to alleviate the symptoms of plantar fasciitis in participants with peripheral neuropathy. Findings of the investigation aim to validate the clinical application of non-invasive ESWT for this population, thereby enhancing their functional independence and health-related quality of life.
- Conditions
- Neuropathic Pain, Plantar Fasciitis
- Being tested
- Extracorporeal shockwave therapy (ESWT)
- Keywords
- neuropathic pain, peripheral neuropathy
- Medical subject headings
- Neuralgia, Fasciitis, Plantar, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwave therapy (ESWT)Device
Also called shockwave
Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive treatment for plantar fasciitis, using acoustic waves to stimulate healing. Participants enrolled in the study will receive real or sham ESWT.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal shockwave therapy (ESWT) | Experimental | Participants of the study will receive real or sham ESWT during the study period Receives: Device: Extracorporeal shockwave therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale of pain
The Visual Analogue Scale (VAS) will be used to assess pain intensity, with scores ranging from 0 (no pain) to 10 (maximal unbearable pain).
Measured: VAS scores will be recorded before and after each ESWT session, as well as two weeks post-intervention. Long-term follow-up evaluations will be conducted at 12 weeks and 12 months following the final treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study startMay 2026 (estimated)
- Primary completionApr 2031 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587255
- Sponsor's protocol ID
- 202602044DINE
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aggarwal P, Jirankali V, Garg SK. Evaluation of plantar fascia using high-resolution ultrasonography in clinically diagnosed cases of plantar fasciitis. Pol J Radiol. 2020 Jul 24;85:e375-e380. doi: 10.5114/pjr.2020.97955. eCollection 2020.
PubMed 32817771
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extracorporeal Shockwave Therapy for Plantar Fasciitis in Patients With Peripheral Neuropathy: A Clinical Evaluation
- ClinicalTrials.gov ID
- NCT07587255
- Acronym / sponsor ID
- 202602044DINE
- Conditions
- Neuropathic Pain, Plantar Fasciitis
- Keywords
- neuropathic pain, peripheral neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 14 May 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 aims to evaluate the efficacy of extracorporeal shockwave therapy (ESWT) in reducing pain and improving functional outcomes for patients with neuropathy-associated plantar fasciitis.
Detailed description
Plantar fasciitis is the most common cause of heel pain in clinical practice, accounting for approximately 80% of patients presenting with heel pain. Common clinical presentations include unilateral or bilateral foot pain, particularly upon weight-bearing after a period of rest, such as the first steps in the morning. Some patients may also report associated paresthesia, tingling, or a burning sensation. Notably, a considerable number of patients with peripheral neuropathy (PN) also present with coexisting plantar fasciitis. The proposed pathophysiological mechanisms underlying neuropathy-associated plantar fasciitis include progressive degeneration of the plantar fascia due to chronic somatosensory deficits, thickening of the plantar fascia secondary to metabolic syndromes such as diabetic neuropathy, and the loss of foot intrinsic muscle support due to motor nerve involvement. Conventional treatments for plantar fasciitis include nonsteroidal anti-inflammatory drugs (NSAIDs), local corticosteroid injections, and custom orthotics; however, these interventions exhibit significant limitations. While NSAIDs may provide temporary analgesia, their long-term utility is limited by systemic risks, particularly gastrointestinal complications. Local corticosteroid injections effectively reduce inflammation and provide acute symptom relief; however, they carry a risk of plantar fascia rupture, rendering repeated administration clinically unfavorable. Orthotic insoles redistribute biomechanical loading across the foot to reduce mechanical stress; however, they are primarily compensatory and do not facilitate tissue regeneration or fundamental repair of the chronic lesion. Given these limitations in conventional treatments, this study aims to evaluate the efficacy of extracorporeal shockwave therapy (ESWT) in reducing pain and improving functional outcomes for patients with neuropathy-associated plantar fasciitis. The investigators will assess the effects of ESWT on the pathophysiological mechanism of the neuropathic foot to alleviate the symptoms of plantar fasciitis in participants with peripheral neuropathy. Findings of the investigation aim to validate the clinical application of non-invasive ESWT for this population, thereby enhancing their functional independence and health-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shockwave therapy (ESWT) | Experimental | Device: Extracorporeal shockwave therapy (ESWT)Participants of the study will receive real or sham ESWT during the study period |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older and 90 or younger.
- Ability to give informed consent.
- Presence of peripheral neuropathy, confirmed by clinical symptoms, nerve
- conduction study, autonomic function test, quantitative sensory test, or skin biopsy.
- Plantar fasciitis presenting as (1) heel pain persisting for more than 3 months, most noticeable with initial steps after a period of inactivity, but also worse following prolonged weight-bearing, and (2) pain with palpation of the proximal insertion of the plantar fascia.
Key exclusion criteria (11 listed)
- Presence of severe systemic diseases, including severe ischemic heart disease or congestive heart failure (left ventricular ejection fraction < 30%), severe lung diseases with dyspnea, severe generalized edema, uncontrolled diabetes, and systemic infection.
- Presence of severe peripheral vascular disease.
- Presence of an implanted cardiac pacemaker, deep brain stimulator, or metallic implants (for example, internal fixation plates, screws, etc.) within the affected foot or ankle.
- Presence of ruptured or pre-ruptured tendons in the target area. A diagnostic softtissue ultrasound of the plantar foot will be performed to assess tissue integrity if any of the following clinical red flags are identified: localized soft-tissue swelling or ecchymosis; physical examination findings indicative of a loss of continuity or tension in the plantar fascia; a history of local corticosteroid injection within the past 12 months; or a history of surgical intervention involving the affected foot.
- Complete loss of vibration and pinprick sensation at the target area due to neuropathy, or the presence of severe mechanical allodynia (pain evoked by friction or pressure) at the target area with an intensity score of 8 or higher on the Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents the most severe pain.
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 therapy (ESWT)Also: shockwaveExtracorporeal Shock Wave Therapy (ESWT) is a non-invasive treatment for plantar fasciitis, using acoustic waves to stimulate healing. Participants enrolled in the study will receive real or sham ESWT. | Device | Extracorporeal shockwave therapy (ESWT) |
Primary outcome
Visual analogue scale of pain
Time frame: VAS scores will be recorded before and after each ESWT session, as well as two weeks post-intervention. Long-term follow-up evaluations will be conducted at 12 weeks and 12 months following the final treatment.
The Visual Analogue Scale (VAS) will be used to assess pain intensity, with scores ranging from 0 (no pain) to 10 (maximal unbearable pain).
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 14 May 2026.
- Background: PubMed 32817771Aggarwal P, Jirankali V, Garg SK. Evaluation of plantar fascia using high-resolution ultrasonography in clinically diagnosed cases of plantar fasciitis. Pol J Radiol. 2020 Jul 24;85:e375-e380. doi: 10.5114/pjr.2020.97955. eCollection 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extracorporeal shockwave therapy (ESWT) in people with Neuropathic Pain and Plantar Fasciitis, run by National Taiwan University Hospital.
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 11 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 14 May 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact CHIEN-HO LIN, PT, PhD (+886923662018, chienhol@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale of pain (time frame: VAS scores will be recorded before and after each ESWT session, as well as two weeks post-intervention. Long-term follow-up evaluations will be conducted at 12 weeks and 12 months following the final treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07587255, which also lists 1 linked publication.
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 14 May 2026.