High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Neuropathic pain by DN4 (Douleur Neuropathique en 4 Questions) Questions)
研究概览
简要总结
the results of this study may provide an easy non pharmacological modality for dealing with diabetic polyneuropathic pain. Also, the outcome of this study will guide physiotherapists to develop a new noninvasive treatment modality that may improve patient symptoms and promotes their social participation , this in turn may add to clinical role played by therapists in management of diabetic polyneuropathy. In Addition, increased knowledge of the influence of High tone power therapy on neuropathic pain
详细描述
This study will be carried out on sixty diabetic male patients with polyneuropathy with ages 50-60 years . Patient will be randomly assigned to two grouos. group A will include 30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced for 3 times per week, for 3 months for 30 minutes every session.
Group B :
This group will include 30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS with applied frequencies range from 2 to 120 Hz. for 3 times per week for 30 minutes every session during 3 months of intervention.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient selection will be according to the following criteria:
- •Sixty male patients are diagnosed with diabetic polyneuropathy their ages will be ranged from 50-60 years old.
- •All patients are ambulant independently.
- •All patients are under full medical control
- •HbA1c is ranged from 6.5 : 7 %.
- •Patients has diabetes more than 10 years.
排除标准
- •The participants will be excluded if they meet one of the following criteria:
- •Psychiatric disorders or seizures.
- •Visual and auditory impairment or tremors influencing balance.
- •Other neuromuscular disorders.
- •Foot deformities and ulcers.
- •Lower limb operations.
- •Feverish systemic infection
- •cardiac pacemaker.
研究组 & 干预措施
High tone power therapy
30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy
干预措施: high tone power therapy (Device)
TENS
30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS
干预措施: TENS (Device)
结局指标
主要结局
Neuropathic pain by DN4 (Douleur Neuropathique en 4 Questions) Questions)
时间窗: up to 12 weeks
t is a questionnaire has been developed to facilitate detection of neuropathic pain.total score is 10 .diagnosis of neuropathic pain is 4/10.
Pain pressure threshold algometer
时间窗: up to 12 weeks
devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure
次要结局
- Glyclated Haemoglobin Level (HbA1c)(up to 12 weeks)
- life disability(up to 12 weeks)
研究者
Zeinab Mahmoud Awad Allah
senior of physiotherapy
Cairo University