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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
- •Able to be contacted by phone for follow-up.
- •Willing to participate and provide informed consent.
排除标准
- •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.
研究组 & 干预措施
Experimental Group
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.
干预措施: Far-Infrared Radiation (FIR) Socks (Device)
Placebo Socks Group
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.
干预措施: Placebo Socks (Device)
结局指标
主要结局
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale
时间窗: The scale was filled in the baseline
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.
次要结局
- Neuropathic Pain Impact on Quality of Life (NePIQoL)(The scale was filled in the baseline)
研究者
Harun İN
Harun İn, MSc, Principal Investigator
TC Erciyes University