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临床试验/NCT04721847
NCT04721847已完成不适用

Effects of Pain Neuroscience Education in Diabetic Neuropathy

Riphah International University2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2020年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
2
主要终点
Numeric pain rating scale (NPRS)

研究概览

简要总结

To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy

详细描述

Pain neuroscience education (PNE) has shown to have immediate effects on various clinical signs and symptoms associated with central sensitization. Using a model of (innocuous, noxious and allodynia) PNE can be used in combination with exercise therapy, especially treating patients in which the nervous system has become increasingly hypervigilant. Teaching patients about the neuroscience of pain and lead to healthier and more positive attitudes and beliefs regarding chronic pain. Pain in diabetic neuropathy restrict the activity participation and compromise their quality of life. PNE will be helpful in such patients so decreasing pain can improve their quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • History of diabetic ≥ 5 years
  • HbA1C higher and equal to 6.5 %
  • Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) ≥ 12
  • Mini Mental State Examination (MMSE) score ≥ 24

排除标准

  • Known neurological disorder
  • Foot ulcers/candidate of amputation
  • Hearing impaired

结局指标

主要结局

Numeric pain rating scale (NPRS)

时间窗: 6 weeks

The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation.

Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)

时间窗: 6 weeks

Total score is 24. If score \< 12, neuropathic mechanisms are unlikely to be contributing to the patient's pain. If score ≥ 12, neuropathic mechanisms are likely to be contributing to the patient's pain. The S-LANSS has Cronbach α of .76 when completed unaided rising to α=.81 in neuropathic pain so this is reliable tool.

次要结局

  • Diabetic peripheral neuropathic pain impact measure(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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