A nerve maze symbolizing diabetic neuropathy treatment.

Diabetic Neuropathy: Finding the Optimal Treatment Path for Pain Relief

Kai Mendoza in Health & Wellness December 2025 • 4 min read.

"A new study seeks to identify the most effective and tolerable treatment pathways for diabetic neuropathic pain, offering hope for improved quality of life."

Diabetes is on the rise, and with it comes a host of complications, including diabetic peripheral neuropathic pain (DPNP). This nerve damage, causing pain in the feet, legs, and hands, affects a significant portion of individuals with diabetes, severely impacting their quality of life. Current treatment guidelines often involve a trial-and-error approach, leaving many searching for effective and tolerable relief.

The OPTION-DM (Optimal Pathway for Treating Neuropathic Pain in Diabetes Mellitus) study is a multi-centre, double-blind, crossover trial designed to address this critical need. Unlike previous studies, OPTION-DM directly compares different treatment pathways to identify the most clinically beneficial, cost-effective, and tolerated approach for managing DPNP.

This article will explore the OPTION-DM study protocol, shedding light on its innovative design and the potential for improved pain management strategies for those living with diabetic neuropathy. We will delve into the treatment pathways being investigated, the study's objectives, and the anticipated impact on clinical practice.

Unlocking the OPTION-DM Study: A Path to Pain Relief

A nerve maze symbolizing diabetic neuropathy treatment.

The OPTION-DM trial employs a rigorous methodology to determine the optimal treatment path. The study will recruit 392 participants from secondary care DPNP centers across the UK. These participants will be randomly assigned to one of six sequences, ensuring equal representation across the different treatment pathways.

The core of the study revolves around comparing three distinct treatment pathways:

Amitriptyline supplemented with pregabalin (A-P Pathway)
Duloxetine supplemented with pregabalin (D-P Pathway)
Pregabalin supplemented with amitriptyline (P-A Pathway)

Each participant will experience all three pathways in a randomized order. This "crossover" design minimizes individual variability and allows for a more direct comparison of treatment effectiveness. Throughout each pathway, medication dosages will be carefully adjusted based on individual response and tolerability, ensuring a personalized approach to pain management.

The Road Ahead: Implications for DPNP Treatment

The OPTION-DM study holds significant promise for transforming the way diabetic neuropathic pain is managed. By directly comparing commonly used treatment pathways, the study aims to provide clinicians with robust evidence to guide their treatment decisions.

Furthermore, the study incorporates a cost-effectiveness analysis, ensuring that the identified optimal pathway is not only clinically effective but also economically sustainable. The inclusion of a subgroup study will also help determine if specific patient characteristics can predict treatment response, paving the way for personalized pain management strategies.

While the results are still forthcoming, the OPTION-DM study represents a crucial step towards improving the lives of individuals living with diabetic neuropathic pain. The findings are expected to be readily generalizable to current clinical practice, offering a clear roadmap for effective and tolerable pain relief.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.1186/s13063-018-2959-y, Alternate LINK

Title: Multicentre, Double-Blind, Crossover Trial To Identify The Optimal Pathway For Treating Neuropathic Pain In Diabetes Mellitus (Option-Dm): Study Protocol For A Randomised Controlled Trial

Subject: Pharmacology (medical)

Journal: Trials

Publisher: Springer Science and Business Media LLC

Authors: Dinesh Selvarajah, Jennifer Petrie, David White, Steven Julious, Oscar Bortolami, Cindy Cooper, Mike Bradburn, Amanda Loban, Helen Bowler, Lizzie Swaby, Katie Sutherland, Solomon Tesfaye

Published: 2018-10-22

Everything You Need To Know

What is Diabetic peripheral neuropathic pain (DPNP)?

Diabetic peripheral neuropathic pain (DPNP) is nerve damage resulting in pain, often in the feet, legs, and hands, affecting a significant portion of individuals with diabetes. This nerve damage significantly impacts the quality of life for those affected. The OPTION-DM study focuses on DPNP, reflecting the urgency in finding effective pain management strategies for people living with diabetes and related complications.

Why is the OPTION-DM study important?

The OPTION-DM study is crucial because current treatment for DPNP often involves a trial-and-error approach. This study directly compares treatment pathways, aiming to identify the most clinically beneficial, cost-effective, and tolerated approach for managing DPNP. It aims to provide clinicians with evidence-based guidelines to improve patient care and provide relief from pain.

What are the different treatment pathways being compared in the OPTION-DM study?

The OPTION-DM study compares three main treatment pathways: Amitriptyline supplemented with pregabalin (A-P Pathway), Duloxetine supplemented with pregabalin (D-P Pathway), and Pregabalin supplemented with amitriptyline (P-A Pathway). Each participant experiences all three pathways in a randomized order (crossover design). Dosages are adjusted based on individual response and tolerability for a personalized approach.

How is the OPTION-DM study designed?

The study protocol involves a multi-centre, double-blind, crossover trial. The OPTION-DM study will recruit 392 participants from secondary care DPNP centers across the UK. Participants are randomly assigned to one of six sequences. This design minimizes individual variability and allows for a direct comparison of treatment effectiveness.

What impact is the OPTION-DM study expected to have on the treatment of DPNP?

The OPTION-DM study holds significant implications for transforming the way DPNP is managed. By directly comparing commonly used treatment pathways, the study aims to provide clinicians with robust evidence to guide their treatment decisions. This research can lead to improved pain management strategies, increased quality of life for patients, and more efficient use of healthcare resources by identifying optimal treatment paths.