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

Official title

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

Overview

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.

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.

Primary outcome measures

• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 32817771

Identifiers

NCT: NCT07587255 · 202602044DINE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗