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NOT YET RECRUITING

NCT07587255

PHASE2

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

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

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.

Official title: Efficacy of Extracorporeal Shockwave Therapy for Plantar Fasciitis in Patients With Peripheral Neuropathy: A Clinical Evaluation

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2026-05

Completion Date

2032-05

Last Updated

2026-05-14

Healthy Volunteers

Conditions

Neuropathic Pain Plantar Fasciitis

Interventions

DEVICE

Extracorporeal shockwave therapy (ESWT)

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.