Efficacy of Extracorporeal Shockwave Therapy on Plantar Fasciitis in Patients With Peripheral Neuropathy

NCT07587255 | Not Yet Recruiting Phase 2

• 1 other identifier: 202602044DINE
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neuropathic Pain; Plantar Fasciitis

Keywords

neuropathic pain; peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

Study Arms (1)

Extracorporeal shockwave therapy (ESWT)

EXPERIMENTAL

Participants of the study will receive real or sham ESWT during the study period

Device: Extracorporeal shockwave therapy (ESWT)

Interventions

Extracorporeal shockwave therapy (ESWT) DEVICE

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.

Also known as: shockwave

Extracorporeal shockwave therapy (ESWT)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Publications (1)

• 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.

  PMID: 32817771 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Fasciitis, Plantar; Peripheral Nervous System Diseases

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

CHIEN-HO LIN, PT, PhD

CONTACT

+886923662018; chienhol@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): May 1, 2032
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share