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

NCT06880484 | Enrolling By Invitation

• 1 other identifier: 1782/1762
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathy (DPN)

Keywords

Diabetic Peripheral Neuropathy; Neuropathic Pain; Far-Infrared Therapy; Infrared Socks; Quality of Life; Diabetes Complications; Non-Pharmacological Treatment; Randomized Controlled Trial; Pain Management

Outcome Measures

Primary Outcomes (1)

• 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.

  The scale was filled in the baseline

Secondary Outcomes (1)

• Neuropathic Pain Impact on Quality of Life (NePIQoL)

  The scale was filled in the baseline

Other Outcomes (2)

• Change in Electroneuromyography (ENMG) Parameters

  Electromyography (EMG) evaluations will be conducted twice during the study

• Visual Analog Scale (VAS)

  The scale was filled in the baseline

Study Arms (2)

Experimental Group

EXPERIMENTAL

Patients will be selected from those attending endocrinology and neurology clinics or hospitalized and meeting the inclusion criteria. Participants will complete the Patient Information Form, LANSS Scale, and NePIQoL forms in a quiet room in the endocrinology ward. The Ankle Brachial Index will be evaluated to exclude peripheral arterial disease. If ENMG and lab findings are unavailable, patients will be referred for necessary tests. They will receive two pairs of FIR socks to be worn at least 8 hours daily, along with usage training. Contact information will be collected. Participants will be called three times to assess compliance and comfort via VAS. After three months, they will return for a final evaluation, including an ENMG scan by neurology specialists, and complete the LANSS Scale and NePIQoL forms again.

Device: Far-Infrared Radiation (FIR) Socks

Placebo Socks Group

PLACEBO COMPARATOR

Placebo group patients will be selected from those attending endocrinology and neurology clinics or hospitalized and meeting inclusion criteria. Participants will complete the Patient Information Form, LANSS Scale, and NePIQoL forms in a quiet room. The Ankle Brachial Index will be evaluated to exclude peripheral arterial disease. If ENMG and lab findings are unavailable, patients will be referred for necessary tests. They will receive two pairs of non-FIR socks to be worn at least 8 hours daily, along with usage training. Contact information will be collected. Participants will be called three times to assess compliance and comfort via VAS. After three months, they will return for a final evaluation, including an ENMG scan by neurology specialists, and complete the LANSS Scale and NePIQoL forms again.

Device: Placebo Socks

Interventions

Far-Infrared Radiation (FIR) Socks DEVICE

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.

Also known as: Far-Infrared Therapy Socks

Experimental Group

Placebo Socks DEVICE

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.

Also known as: Non-FIR Socks

Placebo Socks Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes Üniversitesi

Talas, Kayseri, 38280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neuralgia; Diabetes Complications; Agnosia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Endocrine System Diseases; Perceptual Disorders; Neurobehavioral Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Harun İn, MSc, Principal Investigator

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: March 17, 2025
• Study Start: February 2, 2025
• Primary Completion: February 3, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

TU (1)