Posterior Tibial Nerve PRF for Diabetic Neuropathic Pain

NCT06463015 | Completed

• 1 other identifier: PTNPRF for Diabetic Neuropathy
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the efficacy of ultrasound (US)-guided posterior tibial nerve pulsed radiofrequency (PTN PRF) in the treatment of painful diabetic peripheral neuropathy (DPNP) refractory to conservative treatments. For this evaluation, the visual analog scale (VAS), PainDETECT neuropathic pain scores, and Jenkins Sleep Scale (JSS) will be used before and after the PTN PRF.

Conditions

Diabetic Neuropathies, Painful; Diabetic Neuropathy Peripheral

Keywords

Pulsed Radiofrequency Treatment; Ultrasonography; Tibial Nerve

Outcome Measures

Primary Outcomes (1)

• Visual analog scale

  Visual analog scale (VAS) is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

  Change from baseline to 1st and 3rd month after treatment

Secondary Outcomes (2)

• painDETECT neuropathic pain questionnaire

  Change from baseline to 1st and 3rd month after treatment

• The Jenkins Sleep Scale

  Change from baseline to 1st and 3rd month after treatment

Study Arms (1)

pulsed radiofrequency group

OTHER

posterior tibial nerve pulsed radiofrequency for painful DPNP

Procedure: ultrasound-guided posterior tibial nerve pulsed radiofrequency

Interventions

ultrasound-guided posterior tibial nerve pulsed radiofrequency PROCEDURE

The posterior tibial nerve (PTN) was identified with a 5-12 MHz linear ultrasonography (US) probe at the level of the medial malleolus, where it runs posterior to the posterior tibial artery. Using the in-plane technique, a 22-gauge, 10-cm radiofrequency cannula was inserted under US guidance and advanced until the tip was adjacent to the nerve. Pulse radiofrequency was applied at 42°C for 240 s with a pulse width of 20 ms

pulsed radiofrequency group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>5 years of Type 2 DM diagnosis,
• \>2 years of neuropathic pain complaints (pain-DETECT score \>19),
• Between the ages of 18-70,
• \>1 year of persistent severe pain with a VAS\>6 despite effective multiple medical treatment,
• Diagnosis of distal symmetric polyneuropathy confirmed by electroneuromyelography (ENMG)

You may not qualify if:

• Other diseases that may lead to distal symmetric polyneuropathy (non-DM endocrinopathies, such as B12-folate deficiency),
• Pregnancy
• Coagulopathy, antiaggregant/anticoagulant/antiplatelet use,
• Psychiatric illness

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Diskapi Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Gokhan Yildiz

  Diskapi TRH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor Investigator

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: June 12, 2024
• Primary Completion: December 12, 2024
• Study Completion: December 30, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

TU (1)