Diaphragm's Manual Therapy Reduce Pain in Patients With Chronic Neck Pain: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The aim of this study is to evaluate the effect of diaphragm's manual therapy in addition to cervical spine manual therapy in terms of pain, cervical spine range of motion, trigger points pain pressure threshold, disability and quality of life in patient with chronic aspecific 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 (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 since at least 3 months
- •Age > 18 years and < 65 years
- •Male or Female
排除标准
- •Pregnancy
- •Contraindications for manual therapy or inability to complete the treatment
- •Patients who received a physiotherapy or osteopathic treatment during the last 3 months
- •Medical diagnosis of rheumatologic disease
- •Medical diagnosis of respiratory disease (COPD, asthma)
- •Spine surgery
- •Medical diagnosis of past or present cancer
- •Thoracic or abdominal surgery in the last 3 years
- •Whiplash injuries
- •Previous cervical fracture
- •Cervical anatomical changes
- •Thrombotic events
- •Body temperature greater than 37 degrees in the previous 48 hours
- •Obesity (BMI greater than 30)
研究组 & 干预措施
Real Treatment Group
Patients included in this group will receive 3 multifaced physiotherapy/osteopathic treatments + experimental manoeuvres, 1 treatment/week. Each session will last about 30 minutes.
干预措施: Real Treatment Group (Behavioral)
Sham Treatment Group
Patients included in this group will receive 3 multifaced physiotherapy/osteopathic treatments + sham manoeuvres, 1 treatment/week. Each session will last about 30 minutes.
干预措施: Sham Treatment Group (Behavioral)
结局指标
主要结局
Change in Numeric Pain Rating Scale (NPRS)
时间窗: Week 0, 1, 2, 3, 13, 25
The NPRS is an 11-point scale from 0-10 (0 = no pain; 10 = the most intense pain imaginable). Measures the subjective intensity of pain. Patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours.
次要结局
- Adverse events(Week 2, 3, 13, 25)
- Change in Range of motion (ROM)(Week 0, 1, 2, 3, 13, 25)
- Change in Pain pressure threshold(Week 0, 1, 2, 3, 13, 25)
- Change in Neck Disability Index (NDI)(Week 0, 3, 13, 25)
- Change in Medical outcomes study short form 36 (SF-36)(Week 0, 3, 13, 25)
研究者
Marco Da Roit
PT, MSc
Università degli Studi di Ferrara