Comparison of the Efficacy of Posterior Tibial Nerve Neuromodulation and Extracorporeal Shock Wave Therapy for Heel Spur: A Randomized Controlled Trial

NCT06558552 | Completed

• 1 other identifier: heelspur
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Heel pain is an important clinical condition that impairs patients' quality of life and causes loss of workforce. Heel spurs are one of the most important causes of heel pain. Heel spur, often plantar fascia calcaneus It is seen at the site of attachment to the tuberosity and is plantar It develops secondary to microtrauma to the calcaneus following inflammation of the fascia , and over time, an organized bone protrusion called a spur forms in the same area . Plantar in patients with heel spurs It is often accompanied by fasciitis . Heel spurs are more common in women. It increases with increasing age due to mechanical trauma to the heel. Its incidence is not clearly known . In its etiology, age, gender, obesity, foot structure that disrupts biomechanics, rheumatological and metabolic diseases, and trauma come to the fore . Nonsteroids in the treatment of heel spurs There are treatment options such as anti-inflammatory drugs (NSAIDs), other analgesics, exercise, splints and orthoses, shoe insoles and pads, corticosteroid injections into the spur area and extracorporeal shock wave therapy (ESWT). There are a limited number of studies in which pulse radiofrequency (PRF) and injection were applied to the posterior tibial nerve, which senses the region , and conventional or pulse radiofrequency was successfully applied to the lesion area . ESWT is a non-invasive method. A shock wave is created together with sound and pressure waves. Changes at the cellular level with the shock wave include increased collagen production, increased blood flow in the applied area, acceleration of wound healing and cellular proliferation. In ESWT, radial and focal waves are applied depending on the tissue depth. patellar tendinopathy , plantar fasciitis , myositis It is an effective and reliable method that is frequently used in the treatment of ossificans , lateral epicondylitis , iliotibial band syndrome, many tendinopathies and heel spurs . PRF is a newer neuromodulation method than conventional radiofrequency. It increases c-fos gene expression at the cellular level in neurons without causing destructive damage to the nerve , and A-delta and C fibers are affected. algogenic neuromediators decrease, endogenous opioids such as Dynorphin , Enkephalin and Endorphin increase, thus reducing pain.

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• foot function index

  four months

Study Arms (2)

Neuromodulation of the Posterior Tibial Nerve in the Heel Spur (Epin Calcanei)

OTHER

Other: transcutaneous pulsed radiofrequency

extracorporeal shock wave therapy (ESWT)

OTHER

Other: extracorporeal shock wave therapy (ESWT)'

Interventions

transcutaneous pulsed radiofrequency OTHER

Instead of invasive application of PRF directly to the lesion area or nerve, transcutaneous pulsed radiofrequency (TCPRF) is applied noninvasively.

Neuromodulation of the Posterior Tibial Nerve in the Heel Spur (Epin Calcanei)

extracorporeal shock wave therapy (ESWT)' OTHER

A shock wave is created together with sound and pressure waves. Changes at the cellular level with the shock wave include increased collagen production, increased blood flow in the applied area, acceleration of wound healing and cellular proliferation.

extracorporeal shock wave therapy (ESWT)

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-65,
• Patients diagnosed with calcaneus spur and epin calcaneus in radiological imaging with anamnesis, clinical and physical examination
• Patients who signed the voluntary consent form

You may not qualify if:

• Patients who have undergone interventional procedures for heel spurs in the last 6 months,
• Morbidly obese patients (BMI\>35 kg/m2),
• Patients with advanced decompensated heart failure and pacemakers,
• Patients with known transcutaneous pad allergy, patients with skin infection in the area where ESWT was performed or pads were attached,
• Patients with metal implants,
• Patients with circulatory disorders and lesions,
• Patients who cannot communicate and cannot be positioned,
• Patients with bleeding disorders, patients with severe psychosis and progressive neurological deficits and muscle diseases,
• and pregnant women.

Sponsors & Collaborators

• Halil Ibrahim Altun: lead

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• halil ibrahim altun, specialist

  Kanuni Sultan Süleyman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: pain specialist

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 16, 2024
• Study Start: September 1, 2024
• Primary Completion: November 20, 2024
• Study Completion: April 30, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)