The Effect of Central Nervous System Focused Treatment Program in Chronic Nonspecific Neck Pain -Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- The Numerical Rating Scale (NPRS-11)
研究概览
简要总结
Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Pharmacological and non-medical treatments such as physiotherapy are applied in its treatment. Patients with chronic nonspecific neck pain (CNSP) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. However, it is also reported that chronic pain occurs as a result of neuroplasticity, that is, the brain learning pain through the central synthesis mechanism in the central nervous system. For this reason, although the importance of central nervous system-oriented therapies is increasing day by day, this system-oriented therapies are still ignored in clinics. Therefore, in this master's thesis study, it is aimed to investigate the effects of central nervous system-focused therapies (pain neuroscience education, breathing exercises and relaxation exercises with guided imagery) on pain, range of motion, functional status, pain-related fear, anxiety, depression and quality of life in addition to traditional physiotherapy applied to patients with CNSP.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with nonspecific neck pain by a doctor,
- •To be between the ages of 18-65,
- •Having neck pain for more than 3 months
- •No previous neck or shoulder surgery,
- •No shoulder pain due to any cause,
- •A tumour or inflammatory disease underlying the neck pain not to be found,
- •A clinically underlying stenosis or discogenic problem not to be present.
- •Negative results from the following clinical examination tests;
- •Spurling test,
- •Lhermitte test,
- •Cervical distraction test,
- •Adson test,
排除标准
- •Not meeting the inclusion criteria,
- •Positive neurological examination (positive motor presence, reflex or sensory abnormalities indicating spinal root compression) or abnormal neurological findings related to nerve compression in the upper limb
- •Systemic rheumatological or metabolic diseases or cancer
- •Refusal to participate in the study,
- •Failure to complete treatment,
- •Having any neurological problem
- •Severe psychological illnesses
研究组 & 干预措施
Traditional Physiotherapy Program
干预措施: Classical Physiotherapy (Other)
Traditional Physiotherapy Program and central nervous system focused treatment program
干预措施: central nervous system focused treatment program (Other)
Traditional Physiotherapy Program and central nervous system focused treatment program
干预措施: Classical Physiotherapy (Other)
结局指标
主要结局
The Numerical Rating Scale (NPRS-11)
时间窗: Change from baseline range of motion at 4th week
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Range of Motion
时间窗: Change from baseline range of motion at 4th week
CROM device will be used. The active range of motion of each individual will be measured and measured in accordance with the manufacturer's procedures
Pressure Pain Threshold
时间窗: Change from baseline range of motion at 4th week
A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).
Neck disability index
时间窗: Change from baseline range of motion at 4th week
Since some parts of the 10-item questionnaire could not be answered by the patients (driving, working life), the average neck disability index score will be calculated by dividing the total score by the number of questions answered. The scoring is between 0 and 50. 0 points means the best result, 50 points means the worst result. 0 - 4 points; no disability, 5 - 14 points; mild disability, 15 - 24 points; moderate disability, 25 - 34 points; severe disability, \> 35 points; complete disability
Fear avoidance belief questionnaire
时间窗: Change from baseline range of motion at 4th week
Fear avoidance belief questionnaire is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
Pain Catastrophizing Scale
时间窗: Change from baseline range of motion at 4th week
Catastrophobia one of the cognitive and emotional outcomes of chronic pain, is an important concept related to the perception of pain. Catastrophobic people tend to feel pain more severe than it actually is. The Pain Catastrophobia Scale consists of 13 items and assesses the frequency of concerns about the perception and persistence of existing pain. It has 3 subheadings: helplessness, magnification and rumination. It is scored as never (0) and always (4). The person can score a total of 52 points
次要结局
- Central Sensitization Scale(Change from baseline range of motion at 4th week)
- Global Rating of Change scale (Patient Satisfaction)(Change from baseline range of motion at 4th week)
- Pittsburgh Sleep Quality Index(Change from baseline range of motion at 4th week)
- SF 12 Quality of life(Change from baseline range of motion at 4th week)
- Hospital Anxiety and Depression Scale(Change from baseline range of motion at 4th week)
研究者
Nuray Alaca
Assoc, Prof. Nuray Alaca, Head of department Physiotherapy and Rehabilitation
Acibadem University