The NEXERCISE-trial: When Pain Neuroscience and Clinical Exercise Physiology Meet: Reshaping Exercise Programs for Patients With Non-specific Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The Nexercise-trial is a blended treatment program for patients with chronic non-specific neck pain. We will investigate whether a blended treatment approach, combining specific neck exercises and general aerobic exercises, has better outcome (on medical impact for the patient and socio-economic impact) than a specific neck exercise program alone or a general aerobic exercise program alone.
详细描述
Chronic non-specific neck pain is a common musculoskeletal complaint in which several biopsychosocial factors can be involved. This condition is associated with a high socio-economic burden. The standard of care treatment for chronic neck pain in clinical practice is a combination of advice, passive manual treatment techniques and neck exercises. The implementation of exercise for the treatment of chronic neck pain is indeed recommended in several clinical guidelines. Nevertheless, exercise programs show positive though limited effects, which can be explained by its biomechanical and physiological effects on muscles and joints, but a current lack of taking into account important biopsychosocial and neurophysiological factors. For instance, specific local exercises can lead to acute pain flare-ups, hampering patient satisfaction and the adherence to exercise programs. While it is shown that general aerobic exercise leads to decreased generalized pain sensitivity, also in the affected body parts, both immediately and on the longer term, although on the longer term the effects on local pain sensitivity are better for specific local exercises.
It can be hypothesized that a blended treatment program in which local specific neck exercises are combined with general aerobic exercise in counteractive amount will avoid pain flare-ups and maladaptive exercise perceptions, positively influencing treatment adherence and generating the most optimal clinical outcome due to the local and general effects.
Therefore the aim of this project is to investigate the effect of a blended treatment program (I) to a specific exercise program alone (C1) and to a general aerobic exercise program alone (C2) on pain intensity and cost effectiveness (primary outcome measures), and also on Global Perceived Effect, other pain-related outcomes, quality of life and functionality, lifestyle factors, and health-economic measures (secondary outcome measures) (O) in chronic non-specific neck pain patients (P).
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
- Double (Participant, 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
- •Neck pain > 3 months
- •Mean pain intensity > 3/10 during the preceding month
- •Native Dutch speaker
- •Being able to walk normally
排除标准
- •People with specific causes of neck pain (such as cervical disc herniation with nerve root impingement, severe osteoarthritis, fractures)
- •Major depression or psychiatric illness
- •Life threatening, metabolic, cardiovascular, neurologic, systemic diseases, diagnosed sleeping disorder
- •Pregnancy or given birth in the preceding year
- •History of head, neck or shoulder surgery
- •Fibromyalgia and chronic fatigue syndrome
- •Body mass index > 30 kg/m2
结局指标
主要结局
Pain intensity
时间窗: After treatment (12weeks)
Pain intensity by the Brief Pain Inventory (BPI). The BPI includes four ratings of pain intensity (items 3-7), and seven other ratings on the impact of pain. Intensity is recorded on numerical scales from zero (no pain) to ten (pain as bad as you can imagine). Also, intensity is rated at the time of completing the questionnaires (pain now) as well as its worst, least, and average over the past day or week. The BPI also records the location of the pain on a diagram of a human figure. Patients are also asked to select words that best describe their pain and to indicate the extent and duration of pain relief obtained from analgesics.
次要结局
- Sleep quality(Baseline and after 12 weeks treatment)
- Insomnia(Baseline and after 12 weeks treatment)
- Stress(Baseline and after 12 weeks treatment)
- Productivity losses(Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months)
- Pain sensitivity(Baseline and after 12 weeks treatment)
- Pain intensity(baseline, after 6 weeks of treatment and 3 months after treatment)
- Neck pain-related disability(Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months)
- Health-related quality of life(Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months)
- Treatment adherence(Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months)
- Global Perceived effect(Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months)
- Cost effectiveness(Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months)
- Central sensitivity(Baseline and after 12 weeks treatment)
- Physical activity(Baseline and after 12 weeks of treatment)
- Medical consumption(Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months)