The Effectiveness of Manual Therapy to the Cervical Spine and Diaphragm,Combined With Breathing Reeducation Exercises, in Patients With Non-specific Chronic Neck Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pain Intensity VAS
研究概览
简要总结
Chronic neck pain (CNP) is reported to be one of the most common musculoskeletal pain syndromes. Studies showed that patients with chronic neck pain compensated with changes in Pain, Function, Musculoskeletal and Respiratory outcomes. The diaphragm is a primary respiratory muscle contributing to postural stability and spinal control. Many studies showed that manual therapy and exercise improve clinical and respiratory outcomes in CNP patients. Few studies highlight the importance of diaphragm manual therapy and Reeducation Breathing Exercises in musculoskeletal diseases and in CNP patients. However, the exact mechanism is still unclear. This study aims to examine the hypothesis that: "Diaphragm Manual Therapy and Breathing Reeducation Exercises combined with cervical manual therapy - improve clinical and respiratory outcomes more than cervical manual therapy intervention only or conventional physiotherapy
详细描述
Chronic neck pain (CNP) may affect the physical, social, and psychological aspects of the individual, contributing to the increase in costs in society and business. Neck pain is a major cause of morbidity and disability in everyday life and at the workplace, in many different countries and populations, but its basic pathology and pathophysiology are still unclear.
CNP patients present respiratory dysfunction and pain presence is accompanied by a varying amount of decrements in several clinical outcomes affecting the neuromusculoskeletal system like disability, range of motion restriction, and decreased proprioception as well as neuromuscular control. However, the quality of life and psychology of patients with CNP are affected in parallel. The diaphragm is the most important respiratory muscle also contributing to postural stability and spinal control. Several studies have shown that diaphragm manual therapy and breathing retraining exercises can improve respiratory, as well as pain, function, and musculoskeletal outcomes in chronic low back pain. However, the effectiveness in patients with chronic neck pain has not been definitively determined in relation to other physical therapy interventions. The primary purpose of the present study is to determine further the effectiveness of Diaphragmatic Manual Therapy and Breathing Reeducation Exercises in CNP patients. The secondary purpose is to investigate the relationship between CNP, breathing dysfunction, pain, disability, and musculoskeletal clinical outcomes.
The present study is expected to recruit 90 patients with CNP. Patients with CNP will be randomly assigned to (1) Diaphragmatic Manual Therapy plus Cervical Manual Therapy plus Breathing Reeducation Exercises (2) Cervical Manual Therapy plus sham Diaphragmatic Manual Therapy and (3) Conventional Physiotherapy. Each participant will receive a particular intervention program depending on their group allocation. All participants will receive two evaluation sessions before and after the intervention.
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 outcome assessor will be blind only for those outcomes that are not self-reported
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who have pain for at least 3 months with non-specific mechanical neck pain
- •Individuals voluntarily participating in the study
- •Patients will also be selected on the basis of demonstrating DB in at least one of a series of tests conducted to assess the extent of their Dysfunctional Breathing (biomechanical, biochemical, psychological)
排除标准
- •Pregnancy
- •Contraindications for manual therapy or inability to complete the treatment
- •Patients who received physiotherapy or osteopathic treatment during the last 3 months
- •Individuals with bronchial asthma, chronic bronchitis, emphysema, bronchiectasis and malignancy
- •Medical diagnosis of rheumatologic disease
- •Medical diagnosis of respiratory disease (COPD, asthma)
- •Spine surgery (cervical, spinal, thoracic or abdominal region)
- •Medical diagnosis of cancer (past or present)
- •Whiplash injuries
- •Previous cervical fracture
- •Cervical anatomical changes
- •Thrombotic events, Anaemia or Diabetes
- •Body temperature greater than 37 degrees in the previous 48 hours
- •Obesity (BMI greater than 40)
- •Scoliosis or other diseases that cause spine and chest deformity
- •Positive cervical region instability and positive vertebral artery test
- •Individuals with neurological deficits or with motor loss
- •Individuals who have whiplash injuries, osteoporosis, or rheumatoid disease (such as rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome)
结局指标
主要结局
Pain Intensity VAS
时间窗: change from baseline up to 4 weeks and up to 3 months
Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 100 (Worst Outcome)
Change in Neck Disability Index (NDI)
时间窗: change from baseline up to 4 weeks and up to 3 months
The NDI consists of 10 sections. Each section is scored on a 0 (no pain) to 5 (worst imaginable pain) rating scale. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.
次要结局
- Nijmegen Questionnaire (NQ)(change from baseline up to 4 weeks and up to 3 months)
- Hi-Lo test(change from baseline up to 4 weeks and up to 3 months)
- Hospital and Anxiety Depression Scale (HADS) (Greek version 2007)(change from baseline up to 4 weeks and up to 3 months)
- Change in Range of motion (ROM)(change from baseline up to 4 weeks and up to 3 months)
- Tampa Scale for Kinesiophobia (TSK) (Greek version 2005)(change from baseline up to 4 weeks and up to 3 months)
- Craniovertebral Angle(change from baseline up to 4 weeks and up to 3 months)
- End Tidal CO2 (ETCO2) and Respiratory Rate (RR)(change from baseline up to 4 weeks and up to 3 months)
- Breath Holding Time(change from baseline up to 4 weeks and up to 3 months)
- Adverse events(change from baseline up to 4 weeks and up to 3 months)
- Single Breath Count (SBC)(change from baseline up to 4 weeks and up to 3 months)
- Chest Expansion(change from baseline up to 4 weeks and up to 3 months)
研究者
Tatsios Petros
Phd cand., MSc, MSc, OMPT, CMP, Clinical Instructor Manual Therapy
University of West Attica