Effects of Adding Photobiomodulation to a Specific Therapeutic Exercise Program for the Treatment of Individuals With Chronic Nonspecific Neck Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Functional disability
研究概览
简要总结
In the current clinical and scientific reality, conservative treatment is the most coherent clinical management with a view to the proper rehabilitation of patients with chronic neck pain, with a trend towards the use of therapeutic exercise. However, some uncertainty about the effectiveness of therapeutic exercises still remains, requiring further studies with high methodological rigor, especially with regard to multimodal treatment, such as the combination of therapeutic exercises with photobiomodulation. Thus, the objective of this project is to evaluate the effects of adding photobiomodulation to a program of specific therapeutic exercises for the treatment of individuals with chronic non-specific neck pain. For this, 60 participants will be randomized into two groups: therapeutic exercise group + photobiomodulation (n = 30), and therapeutic exercise group (n = 30). There will be 10 treatment sessions and participants will be evaluated before, after the 10 sessions, and 4 weeks after the end of treatment using the Numerical Pain Scale, Neck Disability Index, Catastrophic Thoughts about Pain Scale, and Tampa Kinesiophobia Scale. In the statistical analysis, a linear mixed model will be applied, considering the interaction between the time and group factors. Finally, the addition of photobiomodulation to a therapeutic exercise program is expected to generate clinical improvements for patients with chronic 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
- Double (Investigator, Outcomes Assessor)
盲法说明
The principal investigator will not be part of any assessment or treatment process.
Two researchers will be solely responsible for evaluating the outcomes. These will not participate in any other process. And they did not know the allocation of participants in their respective groups.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With chronic neck pain (for more than 90 days)
- •Identified according to the following criteria: NDI score ≥ 5
- •Numerical Pain Scale (END) score ≥ 3 at rest or during active neck movement
排除标准
- •Individuals who had a history of cervical trauma; head, face, or cervical surgery
- •Degenerative diseases of the spine
- •Pain radiating to the upper limbs
- •Having been submitted to physiotherapeutic treatment for the cervical region in the last three months
- •Use of analgesics, anti-inflammatory drugs, or muscle relaxants in the last week; the presence of systemic diseases
- •Medical diagnosis of fibromyalgia.
结局指标
主要结局
Functional disability
时间窗: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
The NDI will be used to verify the degree of disability due to neck pain.Each question has six potential responses ranging in severity from zero (no disability) to five (most severe disability) with a total score maximum of 50 points.
Numerical Pain Scale
时间窗: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.
次要结局
- Catastrophic Thoughts about Pain Scale(Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.)
- Kinesiophobia Tampa Scale(Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.)
- The Copenhagen Neck Functional Disability Scale (CNFDS)(Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.)
- Global Perception of Change scale(Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.)
研究者
Cid André Fidelis de Paula Gomes
Phd, professor
University of Nove de Julho