Far-Infrared Socks for Neuropathic Pain and Nerve Function in Diabetic Patients

Официальное название

Effect of Far-Infrared Emitting Socks on Neuropathic Pain, Nerve Conduction, and Quality of Life in Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial

Обзор

This study aims to evaluate the effectiveness of far-infrared radiation (FIR) emitting socks in improving neuropathic pain, nerve conduction, and quality of life in patients with diabetic peripheral neuropathy (DPN). It is the first comprehensive study in Turkey investigating FIR technology for DPN treatment and offers an alternative approach to traditional methods.The study will be conducted at Erciyes University Gevher Nesibe Hospital between February 2025 and June 2026 as a randomized controlled trial (RCT) with a triple-blind design. Participants will be assigned to either the FIR socks group or the placebo group, with both groups receiving two pairs of socks to wear daily. Assessments will include the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale, the Neuropathic Pain Impact on Quality of Life (NePIQoL) questionnaire, and the Visual Analog Scale (VAS) for patient-reported outcomes. Electroneuromyography (ENMG) testing will also be performed before and after the intervention to assess nerve function. This research is expected to provide clinical evidence on FIR socks as a non-pharmacological treatment for neuropathic pain, contributing to improved patient care and the development of innovative medical technologies in Turkey.

Вмешательства

• Устройство Far-Infrared Radiation (FIR) Socks
  Participants in the experimental group will receive two pairs of Far-Infrared Radiation (FIR) emitting socks, designed to be worn for at least 8 hours per day over a 3-month period. These socks utilize FIR technology, which is hypothesized to improve circulation, reduce neuropathic pain, and enhance quality of life in patients with diabetic peripheral neuropathy (DPN). Participants will be educated on the proper use of the socks, provided with a usage protocol, and monitored for adherence via th
• Устройство Placebo Socks
  Participants in the placebo group will receive two pairs of non-FIR socks, which are visually identical to the FIR socks but lack FIR-emitting properties. They will follow the same 8-hour daily usage protocol for 3 months and receive the same education on sock usage. Compliance and comfort will be monitored through three follow-up phone calls, and assessments will be conducted using the VAS, LANSS Scale, and NePIQoL forms. At the end of the study, participants will undergo a final ENMG evaluatio

Первичные конечные точки

• Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale [Срок оценки: The scale was filled in the baseline]

Вторичные конечные точки (1)

• Neuropathic Pain Impact on Quality of Life (NePIQoL) [Срок оценки: The scale was filled in the baseline]

Критерии участия

Критерии включения

• Diagnosed with diabetic peripheral neuropathy (DPN) with mild to moderate severity based on clinical evaluation.
• Oriented to person, place, and time (cognitively intact).
• Residing in Kayseri and receiving treatment in the city.
• HbA1C level below 8.5% during the study period.
• Non-smoker for at least 6 months.
• Not using neuropathic pain medication for at least 3 months before enrollment.
• Body Mass Index (BMI) between 25 - 35.
• Able to be contacted by phone for follow-up.
• Willing to participate and provide informed consent.

Критерии исключения

• Presence of diabetic foot ulcers.
• Non-mobilized individuals (unable to walk independently).
• Severe peripheral artery disease (Ankle Brachial Index (ABI) < 0.4).
• Liver failure or renal failure (dialysis patients).
• Coronary artery disease.
• Candidates for surgery during the intervention period.
• Lower extremity arthroplasty or orthosis indication during the intervention period.
• Neurological or cognitive impairments (e.g., dementia, Alzheimer's disease).
• Receiving non-pharmacological treatment for diabetic peripheral neuropathy (DPN).
• Chronic alcohol or substance use.
• Severe anemia, vitamin B12 deficiency, or iron deficiency anemia.
• Recent changes in diabetes medication or newly diagnosed with diabetes.
• Neurological, cardiovascular, or orthopedic damage affecting the lower extremities.
• Use of cytotoxic or immunosuppressive agents or history of radiation therapy.
• Pregnant, breastfeeding, or attempting to conceive.
• Receiving physiotherapy at any point during the study period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Erciyes Üniversitesi — Talas

Идентификаторы

NCT: NCT06880484 · 1782/1762 · 1782/1762

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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