A single blinded randomized controlled trial assessing the effect of photobiomodulation therapy on neuron specific biomarkers in type II diabetes mellitus patients with peripheral neuropathy

IF 6.1 3区 医学 Q1 ENDOCRINOLOGY & METABOLISM Diabetes research and clinical practice Pub Date : 2025-03-14 DOI:10.1016/j.diabres.2025.112087
M. Anju , Saleena Ummer Velladath , G. Arun Maiya , Manjunath Hande
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Abstract

Background

Diabetic peripheral neuropathy is one of the most devastating complications of long-term diabetes mellitus, associated with functional limitations and poor quality of life.

Materials and methods

Two hundred subjects were randomized into intervention and control group, with one hundred in each arm. The intervention arm received photobiomodulation therapy for ten days, with Low −Level Helium-Neon Laser at a wavelength of 632.8 nm of dosage 3.1 J/cm2 for 9 min on both the dorsal and plantar surfaces of the foot, while the control group received sham laser. Patients were assessed at day 0 of treatment and four weeks after treatment for all the clinical and neuropathy-specific biomarkers. Serum levels of Neuron specific enolase (NSE), Calcitonin gene related peptide (CGRP) Nerve Growth Factor (NGF) for monitoring neuronal changes and monofilament test, Biothesiometer, Numeric Pain Rating Scale (NPRS) to analyze vibration sensation, and pain score. The neuropathic quality of life was assessed using the Norfolk Quality of Life Questionnaire- Diabetic Neuropathy (Norfolk QOL-DN).

Result

Trial found significant changes in serum NSE (p < 0.001), CGRP(p < 0.001), MNSI(p < 0.001), VPT(p < 0.001), NPRS(p < 0.001), and NQL(p < 0.001) in the intervention group four weeks after receiving photobiomodulation therapy, whereas no changes in NGF levels(p = 0.937). This was in correlation with improved neuropathic pain and quality of life.

Conclusion

Serum levels of NSE and CGRP may be good indicators of effectiveness of photobiomodulation in reducing neuropathic pain and other symptoms in individuals with DPN. Reduced neuropathic symptoms, improved protective sensation of foot and quality of life, and reduced neuropathic pain was observed in intervention group.
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背景糖尿病周围神经病变是长期糖尿病最严重的并发症之一,与功能受限和生活质量低下有关。干预组接受为期十天的光生物调节疗法,使用波长为 632.8 纳米、剂量为 3.1 焦耳/平方厘米的低强度氦氖激光,在足背和足底照射 9 分钟;对照组接受假激光。患者在治疗第 0 天和四周后接受所有临床和神经病变特异性生物标记物的评估。血清中的神经元特异性烯醇化酶(NSE)、降钙素基因相关肽(CGRP)、神经生长因子(NGF)水平用于监测神经元变化,单丝测试、生物血压计、数值疼痛评分量表(NPRS)用于分析振动感觉和疼痛评分。使用诺福克生活质量问卷--糖尿病神经病变(Norfolk QOL-DN)评估神经病变的生活质量。001) 、MNSI(p < 0.001) 、VPT(p < 0.001) 、NPRS(p < 0.001) 和 NQL(p < 0.001) ,而 NGF 水平没有变化(p = 0.937)。结论血清中的 NSE 和 CGRP 水平可能是光生物调制疗法在减轻 DPN 患者神经病理性疼痛和其他症状方面效果的良好指标。干预组的神经病理性症状减轻,足部保护性感觉和生活质量提高,神经病理性疼痛减轻。
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来源期刊
Diabetes research and clinical practice
Diabetes research and clinical practice 医学-内分泌学与代谢
CiteScore
10.30
自引率
3.90%
发文量
862
审稿时长
32 days
期刊介绍: Diabetes Research and Clinical Practice is an international journal for health-care providers and clinically oriented researchers that publishes high-quality original research articles and expert reviews in diabetes and related areas. The role of the journal is to provide a venue for dissemination of knowledge and discussion of topics related to diabetes clinical research and patient care. Topics of focus include translational science, genetics, immunology, nutrition, psychosocial research, epidemiology, prevention, socio-economic research, complications, new treatments, technologies and therapy.
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