The Effect of Foot-Ankle Exercises on Pain, Sleep Quality and Depression in Individuals With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Visual Analog Scale for Pain
研究概览
简要总结
It is known that the pain experienced by individuals with diabetic neuropathy negatively impacts sleep and quality of life, leading to numerous psychosocial problems such as anxiety and depression. Studies in the literature indicate that exercise, a non-pharmacological method, improves pain and sleep quality in individuals with diabetic neuropathy. However, no studies have been found evaluating the effects of foot-ankle exercises on pain, sleep quality, and depression in individuals with diabetic neuropathy.
This research aims to examine the effects of foot-ankle exercises on pain, sleep quality, and depression in individuals with diabetic peripheral neuropathy.
This randomized controlled experimental study will be conducted with 70 individuals with diabetes diagnosed with diabetic neuropathy, registered in the patient information systems of two public hospitals. The foot-ankle exercises will be performed by the patients in their homes, twice a day, three days a week, for eight weeks. The research data are as follows: The Introductory Information Form will be collected using the S-Lanns (Self-Leeds Assessment of Neuropathic Symptoms and Sign) Pain Scale, VAS-Visual Analog Scale, Pittsburgh Sleep Quality Index (PSQI), and Beck Depression Inventory (BDI).
This study is important because it will determine the effects of foot and ankle exercises on pain, sleep disturbances, and depression, which are common problems experienced by individuals with diabetic neuropathy.
详细描述
Diabetic neuropathy affects approximately 50% of individuals with diabetes throughout their lives. Diabetic neuropathy accounts for approximately 30-50% of all neuropathy diagnoses. Diabetic neuropathy is classified according to the affected area. Peripheral involvement describes involvement of the lower or upper extremities. Peripheral involvement is more common than involvement of other areas, with a prevalence of 16-87% in individuals with diabetes. Individuals with diabetic peripheral neuropathy typically present to the hospital with numbness, tingling, pain, and loss of sensation in the extremities.
The symptoms experienced in diabetic neuropathy negatively impact individuals' quality of life, and pain is one of the most common symptoms. Diabetic neuropathic pain can be spontaneous, constant, or intermittent, and can be described as burning, stinging, tingling, numbness, or coldness, and can be localized to one or more areas. Neuropathic pain generally worsens at night and is more common in the feet.
Management of diabetic neuropathy includes the use of pharmacological agents, glycemic control, lifestyle changes, risk factor management, assessment of foot ulcer risk, foot care, and non-pharmacological interventions.
Non-pharmacological treatment methods have been shown to be effective in reducing pain and improving quality of life. These include transcutaneous electrical nerve stimulation, spinal cord stimulation, transcranial magnetic stimulation, reflexology, aromatherapy massage, spa treatments, and exercise.
Exercises are also included among the treatment methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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 of age and older
- •Diagnosed with diabetic peripheral neuropathy for at least 6 months S-LANSS pain score ≥ 12
- •Able to perform the exercise program
- •Voluntary participation and informed consent
排除标准
- •Pregnancy
- •Severe cardiovascular or musculoskeletal disease
- •Cognitive impairment preventing participation
- •Receiving physiotherapy or another structured exercise program during the study
- •Any other condition deemed inappropriate by the investigator
结局指标
主要结局
Visual Analog Scale for Pain
时间窗: Baseline and 8 weeks.
Pain severity will be assessed using the Visual Analog Scale for Pain, a 10-cm line on which participants rate their pain intensity from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores represent more severe pain.
次要结局
- Pittsburgh Sleep Quality Index(Baseline and 8 weeks.)
- Self-report Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale(Baseline and 8 weeks.)
- Beck Depression Inventory(Baseline and 8 weeks.)