Modelo Preditivo Para os Resultados de Sucesso Com um Programa Combinado de Terapia Manual e exercício em indivíduos Com Dor Cervical crónica de Origem não-especifica
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 3 weeks.
研究概览
简要总结
The aim of this study is to develop a predictive model to identify which patients with chronic nonspecific neck pain are more likely to benefit from manual therapy and exercise program, or usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Chronic nonspecific neck pain at least 3 months, defined as pain in the cervical region without a specific anatomopathological diagnosis;
- •Adults between 18 and 65 years of age and literate in Portuguese;
排除标准
- •History of cervical trauma and/or history of surgery in the prior 6 months;
- •Clinical signs of infection, tumor, neurological, inflammatory or systemic diseases;
- •Pregnancy
研究组 & 干预措施
Manual Therapy and Exercise
干预措施: Manual Therapy and Exercise (Physiotherapy Intervention) (Other)
Usual Care
干预措施: Usual Care (Physiotherapy Intervention) (Other)
结局指标
主要结局
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 3 weeks.
时间窗: 3 weeks
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at follow-up 3 months.
时间窗: Follow-up 3 months
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).
Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at follow-up 3 months.
时间窗: Follow-up 3 months
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in NDI (range: 0-50 and higher scores are indicative of more disability).
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 6 weeks.
时间窗: 6 weeks
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).
Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 3 weeks.
时间窗: 3 weeks
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in NDI (range: 0-50 and higher scores are indicative of more disability).
Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 6 weeks.
时间窗: 6 weeks
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in NDI (range: 0-50 and higher scores are indicative of more disability).
次要结局
- Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 3 weeks(3 weeks)
- Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 6 weeks(6 weeks)
- Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at follow-up 3 months(Follow-up 3 months)