Pain Neuroscience Education in Diabetic Neuropathy
2021年9月17日 更新者：Riphah International University
Effects of Pain Neuroscience Education in Diabetic Neuropathy
To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
74
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Punjab
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Faisalabad、Punjab、巴基斯坦、46000
- Allied Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Known neurological disorder
- Foot ulcers/candidate of amputation
- Hearing impaired
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Pain Neuroscience Education
Pain Neuroscience Education (PNE) sessions.
Additionally, treated with Transcutaneous Electrical Nerve Stimulation (TENS), Stretching and Strengthening exercises similar as in control group
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In first part educational content will be designed to be given in group of patients in six sessions by PNE booklet.
The six sessions are 1.5 hours long (9 hours) and will be given at a frequency of 1 session per week.
Final session will be given to solve doubts, and to provide additional information to the educational program.
Book for additional material will be delivered to participants.
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有源比较器：Conventional Physical therapy
Control group will be treated by TENS, stretching and strengthening exercises.
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Control group will be treated by Conventional Physical therapy like TENS, stretching and strengthening exercises.
Intervention will be initiated with warm up period (joint mobility exercises) for the duration of 5 mins and ended up with cool down period (relaxing exercises i.e. deep breathing) for the duration of 5 mins.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Numeric pain rating scale (NPRS)
大体时间：6 weeks
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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.
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6 weeks
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Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)
大体时间：6 weeks
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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.
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6 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diabetic peripheral neuropathic pain impact measure
大体时间：6 weeks
|
18 item DPNI is a reliable and valid Patient rating outcome measure disease impacts and treatment for DNP.
Internal consistency ranged from 0.91 to 0.96 and test - retest from 0.84 to 0.91.
All prespecified hypothesis for convergent and discriminant validity were met.
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6 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mirza Obaid Baig, MSPT(NMR)、Riphah International University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年8月13日
初级完成 (实际的)
2021年7月28日
研究完成 (实际的)
2021年8月31日
研究注册日期
首次提交
2021年1月19日
首先提交符合 QC 标准的
2021年1月19日
首次发布 (实际的)
2021年1月25日
研究记录更新
最后更新发布 (实际的)
2021年9月23日
上次提交的符合 QC 标准的更新
2021年9月17日
最后验证
2021年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.