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

N/AEnrolling By InvitationNCT06880484

TC Erciyes University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Diabetic Peripheral Neuropathy (DPN)

Far-Infrared Radiation (FIR) SocksDEVICE

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 three follow-up phone calls assessing compliance and comfort using the Visual Analog Scale (VAS). At the end of the study, participants will undergo a follow-up Electroneuromyography (ENMG) evaluation, and pain and quality of life will be reassessed using the LANSS Scale and NePIQoL forms.

Placebo SocksDEVICE

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 evaluation.This study aims to determine the effect of FIR socks on neuropathic pain, nerve conduction, and quality of life, using both subjective (pain scales) and objective (ENMG) measures.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale

The Leeds Neuropathic Symptoms and Signs Assessment Scale (LANSS) was developed by Bennett (2001) and its Turkish validity and reliability study was conducted by Yücel et al. (2004). It is used clinically to differentiate neuropathic pain from nociceptive pain and consists of a five-item pain questionnaire (max: 16 points) and a two-item sensory assessment (max: 24 points). The pain questionnaire evaluates symptoms like tingling, paresthesia, skin color changes, electric shock sensations, and burning pain. The sensory section includes Allodynia and Pinprick tests; in the Allodynia test, a cotton wisp is applied to painful and non-painful areas-if discomfort is reported in the affected region, allodynia is considered present. If the total score is ≥12, pain is classified as neuropathic, while a score \<12 indicates nociceptive pain. The scale has 82-91% sensitivity and 80-94% specificity when compared to clinical diagnosis.

Time frame: The scale was filled in the baseline

Secondary Outcomes

Neuropathic Pain Impact on Quality of Life (NePIQoL)

The Neuropathic Pain Impact on Quality of Life Questionnaire (NePIQoL) was developed by Poole et al. (2009) to assess the impact of neuropathic pain on quality of life. The Turkish validity and reliability study was conducted by Acar et al. (2016) (Acar et al., 2016; Poole et al., 2009). In the original study, the internal consistency of the total NePIQoL was reported as 0.86, while in the validity and reliability study, it was found to be 0.99. The scale consists of five subdimensions: pain and other symptoms, relationships, daily activities, emotional impact of pain, and personal/self-care. It is a 42-item, 5-point Likert-type scale. The minimum possible score on the questionnaire is 42, while the maximum is 210. A score closer to 210 indicates a greater negative impact of neuropathic pain on quality of life. Conversely, lower scores reflect a better quality of life with less impact from neuropathic pain.