Effects of Focal Vibrations on Neuropathic Pain in Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Short Form McGill Pain Questionnaire
研究概览
简要总结
Most of the literature found on whole body vibrations(WBV) instead of focal muscle vibrations (FMV) in diabetic peripheral neuropathy patients. The studies found on the effects of focal vibrations could not be generalised on the huge population of diabetes mellitus (DM) induced neuropathic pain because of small sample size and due to subordinate studies i.e, pilot studies done on the focal vibrations in which 3 different modes of vibrations is used without comparing with the control group. These studies are not much valuable in literature as well as for clinical purposes due to lack of control group. As mentioned in previous studies that better results achieved with the WBV on pain in diabetic peripheral neuropathyso that the hypothesis can be made that when FMV directly applies on the focal region that may influence the pain and/or peripheral neuropathy status.
详细描述
Diabetic neuropathy is the most common complication associated with diabetes mellitus, affecting approximately 50-70% of patients with diabetes. The prevalence of pain and of paraesthesia were 20% and 33% 10 years after diagnosis of diabetes mellitus (DM). DPN is the leading cause for disability due to foot ulceration and amputation and significantly lowers quality of life (QoL). Neuropathic pain is caused by a lesion or disease of the somatosensory system, including peripheral fibres (Aβ, Aδ and C fibres) and central neurons. Thus the prevalence of DPN and limitations of current studies make evident the need for future research.The study going to be taken with a large sample size, further testing the efficacy of FMV as a treatment for DPN and also check the detraining effects after discontinuation of therapy for 1 month so that the gaps in the literature can be full filled
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic type II patients.
- •Score >12 at Leeds Assessment of Neuropathic Symptoms & Signs (LANSS)
- •Diagnosis of diabetic peripheral neuropathy, using previous history, physical examination and vibration perception test of the patients
- •Post diabetic duration of 10 years
- •Patient with lower limb pain ranges from 3 to 5 on short form McGill pain
排除标准
- •Lower extremity amputation
- •Neuropathy other than diabetes
研究组 & 干预措施
Group A
Focal Muscle vibration will be apply to:
- Tibialis anterior
- The distal quadriceps
- Belly of the gastrocnemius/soleus muscles.
- Sinusoidal vibration intensity range 120 Hz.
- Each muscle will vibration for 10 minutes
- 10 minutes per muscle duration; total 30 minutes
干预措施: Focal muscle vibration (Device)
Group B
Focal Muscle vibration similar to Group A with following:
Conventional Therapy TENS with pulse width 250ms, intensity 14Hz for 30 minutes
Exercise therapy:
Stretching Exercise to:
- Calf
- Hamstring
- Quadriceps
干预措施: Focal muscle vibration (Device)
Group C
TENS with pulse width 250ms, intensity 14Hz for 30 minutes
Exercise therapy:
Stretching Exercise to:
- Calf
- Hamstring
- Quadriceps
干预措施: Focal muscle vibration (Device)
结局指标
主要结局
Short Form McGill Pain Questionnaire
时间窗: 8 weeks
Short Form McGill Pain Questionnaire is used to assess the non-neuropathic or neuropathic pain and describe the different qualities of pain and related symptoms. It has 0 to 10 scale, with 0 begin no pain and 10 begin worst pain.
Short Form McGill Pain Questionnaire
时间窗: 0 week
Short Form McGill Pain Questionnaire is used to assess the non-neuropathic or neuropathic pain and describe the different qualities of pain and related symptoms. It has 0 to 10 scale, with 0 begin no pain and 10 begin worst pain.
Short Form McGill Pain Questionnaire
时间窗: 4 weeks
Short Form McGill Pain Questionnaire is used to assess the non-neuropathic or neuropathic pain and describe the different qualities of pain and related symptoms. It has 0 to 10 scale, with 0 begin no pain and 10 begin worst pain.
次要结局
未报告次要终点