The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in pain level at 4th and 8th weeks compared to baseline.
研究概览
简要总结
The study will be carried out to determine the effect on pain and quality of life between the groups that received and did not receive foot and ankle exercise training.
详细描述
In the literature, in patients with diabetic neuropathy who received foot and ankle exercise training; It is observed that it reduces the level of pain and increases the quality of life. Foot and ankle exercise training given to the participants improved blood circulation, improved foot-ankle range of motion, increased foot muscle strength and function, improved diabetic neuropathy symptoms, redistributed plantar pressure during movement, improved sensitivity, and was effective in maintaining balance; It is thought that participants can reduce pain and improve their quality of life with foot and ankle exercise training. While there are studies examining the effect of non-pharmacological interventions such as spa treatment and pulse electromagnetic field therapy in patients with diabetic neuropathy in our country, no study has been found examining the effect of foot and ankle exercise training on pain and quality of life in patients with diabetic neuropathic pain. It is thought that the results of the research will be beneficial in symptom management and improve quality of life in addition to pharmacological treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and over,
- •Having been diagnosed with Type 2 diabetes for at least one year,
- •Diagnosed with diabetic peripheral neuropathy for at least 6 months by EMG by a neurologist,
- •Individuals with diabetes mellitus with neuropathic pain who score 12 or higher on the S-Lanns (Self-Leeds Assessment of Neuropathic Symptoms and Sign) pain scale,
- •Visual Analogue Scale (VAS) value to be at least 1,
- •Receiving medical treatment for diabetic neuropathy,
- •Did not receive physical therapy and non-pharmacological treatment during the research period,
- •Having no physical and mental problems that will prevent communication,
- •Having blood glucose meters at home,
- •Individuals with smart device use,
排除标准
- •Peripheral vascular complications due to diabetes or another etiology,
- •Having a history of surgery on the knee, ankle and hip and indication for surgery during the intervention period,
- •Those who cannot communicate on the phone (with hearing problems),
- •Having nephropathy, retinopathy and diabetic foot,
- •Neurological diseases (stroke, cerebrovascular diseases, epilepsy) and serious musculoskeletal problems (rheumatoid arthritis, osteoarthritis)
- •Neurocognitive disorder (Alzheimer's disease, dementia),
- •Not taking any physical therapy during the intervention period,
- •Patients with deep vein thrombosis, femur fractures, surgical conditions, open wounds
研究组 & 干预措施
intervention group
The intervention group received training by sending foot and ankle exercise videos to their mobile phones via WhatsApp.
干预措施: foot and ankle exercise (Other)
结局指标
主要结局
Change in pain level at 4th and 8th weeks compared to baseline.
时间窗: Two months
Pain scores of the patients were checked after foot and ankle exercise training. The scale, developed by Price, McGrath, Rafii, and Buckingham, is a measurement tool that evaluates pain severity. The scale is 10 cm long and is graded on a horizontal line (0 = no pain, 10 = most severe pain). The patient is asked to mark a point on this line that corresponds to the intensity of pain he feels. The marked numerical value indicates the severity of the patient's perception of pain. A VAS value of 1 to 4 indicates mild pain, 5-6 indicates moderate pain, and 7-10 indicates severe pain. As scores increase, the level of pain worsens and general health deteriorates.
次要结局
- Effect of neuropathic pain on quality of life at 4 and 8 weeks change from initial state(Two months)
研究者
Ülkü Görgülü Polat
Principal Investigator
Gazi University