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临床试验/NCT07317284
NCT07317284已完成不适用

Evaluation of Peripheral Neurological Integrity and Synergistic Treatment of Photobiomodulation and Therapy Ultrasound in Patirnts With Diabetes Mellitus (Type II): Clinical Study

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in neuropathic pain intensity

研究概览

简要总结

This study aims:

  • To compare conventional diabetic neuropathy screening techniques with user-friendly technological equipment;
  • To evaluate the effects of the combined application of laser and therapeutic ultrasound in the treatment of Diabetic Peripheral Neuropathy (DPN) in its early stages, aiming to prevent severe complications, such as the development of diabetic foot.

Two groups were formed: Treatment group and placebo group. 24 sessions were performed (twice a week, on alternate days). It is concluded that the combined treatment with laser and therapeutic ultrasound for diabetic peripheral neuropathy promotes a significant reduction in symptoms and improvement in sensitivity in patients with diabetic peripheral neuropathy.

详细描述

Diabetes Mellitus (DM) is a chronic disease that currently affects approximately 589 million adults, aged between 20 and 79 years, worldwide. Alarming projections indicate that, by 2050, this number could exceed 853 million individuals in the same age group. The DPN is one of the most common complications of DM, characterized by a set of syndromes with diverse clinical and subclinical manifestations. The neurological damage tends to be extensive, largely compromising the peripheral nervous system in its sensorimotor and autonomic components. The pain has variable intensity, being a constant complaint, commonly described as tingling, burning or a sensation of pins and needles in the extremities, often accompanied by abnormal sensory changes, such as allodynia and hyperalgesia. Early diagnosis of DPN and ongoing monitoring are essential, as they promote education and awareness among diabetic patients, in addition to contributing to delaying or minimizing more serious complications as the disease progresses. This study aims to compare conventional diabetic neuropathy screening techniques with technological and easy-to-use equipment and, from there, evaluate the effects of the combined application of photobiomodulation and therapeutic ultrasound in the treatment of DPN in its early stages, aiming to prevent severe complications, such as the development of diabetic foot (sensory nerve).

Sixty participants were recruited and evaluated with various DPN screening instruments. They were then randomly assigned to two groups: a treatment group and a control group.

The treatment group received combined stimulation with photobiomodulation and therapeutic ultrasound in the sural nerve region, with the following parameters: continuous laser, wavelength of 808 nm, and therapeutic ultrasound with a frequency of 1 MHz, pulsed mode, for 6 minutes on each sural nerve, with rotational movement of the transducer.

The results of objective assessments performed with the DPN Check® showed that, in the treatment group, there was an increase in the "normal" rating, while the "moderate" rating, which was predominant at baseline, increased. In subjective assessments, considering a broad analysis of nerve fiber types, the "normal" rating increased while the "moderate" rating decreased. In the control group, the "normal" rating remained low, and the "moderate" rating remained at 70% in objective assessments. In the subjective evaluations, there was no change in the "normal" classification (remaining at 0% from start to finish), and the "moderate" classification varied little.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

盲法说明

The study's methodological design was double-blind: the evaluators responsible for measuring the outcomes had no prior knowledge of the type of intervention the participants underwent; and the participants themselves were also unaware of which treatment (active or sham) they were receiving. It is worth noting that the researchers responsible for administering the intervention were unaware of the results of the participants' initial assessments and did not participate in the final analyses. This methodological structure directly contributed to reducing observational and analytical biases, promoting greater reliability of the findings.

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type II diabetes diagnosed between 7 and 15 years old;
  • Age between 45 and 70 years;
  • Sex female and male.

排除标准

  • Diabetic foot;
  • Lower limb involvement with metal implants, ankle and foot fractures;
  • Serious illnesses such as malignant or benign tumors;
  • Serious psychological problems;
  • Hormonal disorders;
  • Pacemaker users;
  • Hemodialysis treatment;
  • Drug use;
  • Physiotherapy treatment for less than six months.

研究组 & 干预措施

Diabetic Peripheral Neuropathy in Early Stages: Photobiomodulation and Therapeutic Ultrasound Treatm

Active Comparator

Arm experimental:

Participants allocated to the experimental arm will receive a combined photobiomodulation (PBM) and therapeutic ultrasound (TUS) protocol applied bilaterally over the anatomical pathway of the sural nerve. TUS parameters: 1 MHz frequency, pulsed mode (50% duty cycle), secondary frequency of 100 Hz, intensity of 0.8 W/cm², energy density of 144 J/cm². PBM parameters: 808-nm infrared wavelength, continuous mode, 100 mW power, irradiation area of 0.125 cm², resulting in 36 J total energy per session (286 J/cm²).

干预措施: Active Comparator (Device)

Early diabetic peripheral neuropathy: Sham Group

Sham Comparator

Arm Control (Sham):

Participants allocated to the control arm will undergo a sham procedure designed to mimic the experimental intervention without delivering therapeutic energy. The same device will be used with minimal TUS settings: 1 MHz frequency, 50% duty cycle, secondary frequency of 16 Hz, intensity of 0.1 W/cm², energy density of 18 J/cm². The PBM emitter will remain off to ensure no light emission.

干预措施: Sham Group Arm (Device)

结局指标

主要结局

Change in neuropathic pain intensity

时间窗: Baseline and after 12 weeks of intervention.

Changes in the severity of neuropathic symptoms (pain, burning, tingling, and numbness) in patients with diabetic peripheral neuropathy were evaluated using the following instruments: (1) Neuropathy Disability Score (NDS), a clinical scale that quantifies neuropathic severity through neurological examination. Scores range from 0 to 10 points, with higher values indicating greater neurological impairment and worse clinical outcomes, and lower values reflecting better neurological function. (2) DPN-Check, a validated point-of-care diagnostic device used to assess diabetic peripheral neuropathy by measuring sural nerve conduction velocity (NCV, m/s) and sensory nerve action potential (SNAP) amplitude (µV) through a standardized, noninvasive electrophysiological assessment. The device reports NCV values from 20 to 70 m/s and SNAP amplitude values from 0 to 32 µV. Values ≥ 4 µV and ≥ 40 m/s are considered normal, whereas lower values indicate peripheral nerve dysfunction.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juliana da Silva Amaral Bruno

Principal Investigator

Universidade Federal de Sao Carlos

研究点 (1)

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