The Effect of Therapeutic Exercise and Vegan Diet on Pain and Quality of Life in Young Women With Chronic Idiopathic Neck Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Body Mass Index
研究概览
简要总结
45 sedentary volunteer female individuals whose age range is between 18-25 years and diagnosed with chronic idiopathic neck pain by a specialist physical therapy doctor will participate in the study. Participants will be randomly divided into three groups: vegan diet group (n=15), therapeutic exercise group (n=15) and control group (n=15). Participants with chronic neck pain who will be on a vegan diet will follow a diet program prepared by an expert dietitian under the supervision of an endocrinologist. In this diet program, a diet that includes grains, fruits, vegetables, legumes, as well as dairy products and eggs, known as lacto-ovo vegetarian, will be applied. Consumption of meat, poultry, fish, seafood and processed food and beverages will not be allowed. There will be no calorie restriction in the diet, and the diet will be arranged according to the amount of calories calculated by the expert dietitian according to BMI. The diet will last eight weeks. Individuals who follow a diet will be constantly checked by the workers with the mobile device application (My Fitness Pal®). Individuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.The aim of this study is to compare the Effect of Therapeutic Exercise and Vegan Diet on Pain and Quality of Life in Young Women with Chronic Idiopathic Neck Pain.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 18-25,
- •neck pain for at least 3 months,
- •VAS score greater than 5
排除标准
- •using regular analgesic,
- •having had neck surgery,
- •the presence of neurological or specific problems in the neck (vertebral fracture, inflammation, infection, etc.),
- •cortisone use,
- •pregnancy,
- •serious chronic diseases,
- •those with serious psychiatric disorders
- •Individuals who received physical therapy within 3 months
- •Antidepressant use
研究组 & 干预措施
Control group
Participants in this group will not receive any intervention.
Vegan diet
Participants with chronic neck pain who will be on a vegan diet will follow a diet program prepared by an expert dietitian under the supervision of an endocrinologist. In this diet program, a diet that includes grains, fruits, vegetables, legumes, as well as dairy products and eggs, known as lacto-ovo vegetarian, will be applied. Consumption of meat, poultry, fish, seafood and processed food and beverages will not be allowed. There will be no calorie restriction in the diet, and the diet will be arranged according to the amount of calories calculated by the expert dietitian according to BMI. The diet will last for eight weeks. Individuals who follow a diet will be constantly checked by the workers with the mobile device application (My Fitness Pal®).
干预措施: Vegan Diet (Other)
Therapeutic exercise
The participants in the therapeutic exercise group will perform the following therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.
- The patient, sitting in the cervical spine neutral position, performs flexion, extension and rotation of the cervical spine, unloaded and in the maximum possible range of motion.
- While the patient is in the supine position, she performs passive lateral mobilization to the neck with the help of a physiotherapist.
- In the supine position, the patient performs isometric neck flexion, lateral flexion and rotation movements against the manual resistance given by the physiotherapist
- The patient lying on his back does isometric neck extension movement against gravity
- The patient performs isometric neck flexion, lateral flexion and rotation movements against the elastic band in the sitting position
干预措施: Therapeutic exercise (Other)
结局指标
主要结局
Body Mass Index
时间窗: 1 minute
Body mass index will be calculated as weight/height2
Visual Analog Scale (VAS)
时间窗: 2 minutes
Pain intensity was evaluated with the Visual Analogue Scale (VAS). The VAS consists of a 10 cm long horizontal line. 0 means "no pain " and 10 means "unbearable severe pain". Individuals marked the level of corresponding to pain they felt on the 10 cm line, and the values of the marked places were calculated with a 100-millimeter ruler
Neck Disability Index (NDI)
时间窗: 10 minutes
This index consists of 10 parts and the each part of index has 6 different answers. In these 10 parts, there are answers about the severity of neck pain, personal care of the individual, lifting, reading, headache, concentration, work life, driving, sleep and leisure activities. It is scored as 0 (no pain and functional limitation) and 5 (the most severe pain and maximum limitation). In the NDI, 0-4 points were stated as no disability, 5-14 points mild disability, 15-24 points moderate disability, 25-34 points severe disability and 35 points above complete disability
Short Form 36
时间窗: 15 minutes
this questionnaire consists of 36 questions covering eight domains of health and wellbeing corresponding subscales, whichare used to estimate a physical (PCS) and a mental com-ponent score (MCS).The sub-parameters of the test are physical function, physical role difficulty, emotional role difficulty, energy, mental health, social functionality, pain and general health perception. A minimum of 0 and a maximum of 100 points can be obtained from the test. A high scores from the test indicates well-being.
Tampa Scale of Kinesiophobia (TSK-17)
时间窗: 15 minutes
The kinesiophobia was evaluated using the Tampa Scale of Kinesiophobia (TSK-17). The validity and reliability of the scale was performed by Yılmaz et al. There is a 4-point likert scoring in the scale. The total score ranges between 17 and 68. A high value on the TSK-17 indicates a high degree of kinesiophobia and a cut-off score was developed by Vlaeyen et al., where a score of 37 or over is considered a high score.
次要结局
未报告次要终点
研究者
Mustafa Savaş Torlak
Principal Investigator
KTO Karatay University