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临床试验/NCT04057963
NCT04057963已完成不适用

The Inspiratory Muscle Training in Patients With Non-Specific Chronic Neck Pain

Dokuz Eylul University6 个研究点 分布在 2 个国家目标入组 28 人开始时间: 2019年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
6
主要终点
Changes in Fear of Movement

研究概览

简要总结

The aim of the present study is to investigate the effects of additional functional inspiratory muscle training in individuals with non-specific chronic neck pain.

详细描述

Patients participating in the study will be divided two parallel groups. The patients in study group will instruct to perform both functional inspiratory muscle training and conventional treatments for neck pain, the patients in the control group will instruct to perform just conventional treatments. The severity of the pain, disability, fear of movement and depression levels will be assessed by visual analog scale, neck disability index, Tampa Scale of kinesiophobia and beck depression inventory, respectively. Neck postures (craniovertebral angle) will be evaluated by photogrammetric method.Endurance of deep cervical flexor muscles will be measured using Stabilizer Pressure Biofeedback Unit with cranio-cervical flexion test. Pain threshold will be measured by algometer from the middle point of upper trapezius. Cervical proprioceptions will be evaluated by laser pointer method in the right and left rotational directions. In addition, diaphragma thickness will be measured by two-dimensional ultrasonography. Assessments were repeated before and after the treatment.

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
Single (Participant)

盲法说明

Single (Participant)

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • NDI score above 15
  • Be able to adapt exercise commands
  • Neck pain for at least six months
  • Agree to participate in the study

排除标准

  • History of spinal surgery Traumatic cervical injuries Acute or chronic musculoskeletal pain other than neck pain Serious comorbidities (neurological, neuromuscular, cardiological, psychiatric) Tumoral conditions Obesity (Body Mass Index-BMI> 40)

研究组 & 干预措施

Conventional plus Functional Inspiratory Muscle Training Group

Experimental

Conventional program plus functional inspiratory muscle training will be carried out three sessions per week during the six weeks. The content of the program will be the same as for the conventional group. Additional functional inspiratory muscle training will be began with 50% of the maximal inspiratory pressure value in a specific device and it will be progressed 5% every week according to the tolerance.

干预措施: Conventional plus Functional Inspiratory Muscle Training Group (Other)

Conventional Physiotherapy Program

Active Comparator

Conventional program will be carried out three sessions per week during the six weeks. Cervical mobilization techniques (glidings-grade 2) of cyriax will be applied in the direction of lateral flexion and rotation. Stretching exercises, craniovertebral flexion exercise and scapulothoracic strengthening exercises will be performed.

干预措施: Conventional Physiotherapy Program (Other)

结局指标

主要结局

Changes in Fear of Movement

时间窗: change from baseline in disability at 6 weeks

Patients' fear of movement will be assesed by Tampa Kinesiophobia Scale. The scale has 17 pain statements, and the patient selected her agreement for each question using a 4-point scale. The maximum score is 68. Higher score indicates having more fear of movement.

Changes in Pain Severity

时间窗: change from baseline in pain severity at 6 weeks

Patients' resting pain intensities will be assessed by Visual Analog Scale. (a 10 cm horizontal line). There is two anchors in the tips of the visual analog scale and while the zero represented "no pain", ten indicated "excessive pain". The length from the zero to marked point was recorded in cm.

Changes in Depression

时间窗: change from baseline in disability at 6 weeks

Patients' depression levels will be assessed by Beck Depression Inventory. composed 21 questions. The maximum total score is 63. Higher scores demonstrate greater level of depression

Changes in Disability

时间窗: change from baseline in disability at 6 weeks

Patients' disability levels will be assessed by neck disability index. The questionnaire has ten sections; pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored between zero (no disability) and five (total disability). The maximum score is therefore 50. Higher scores indicates having more disability.

次要结局

  • Cervical Proprioception(change from baseline in disability at 6 weeks)
  • Pain threshold(change from baseline in disability at 6 weeks)
  • Craniovertebral Angle(change from baseline in disability at 6 weeks)
  • Cranio-cervical flexion endurance(change from baseline in disability at 6 weeks)
  • Diaphragma thickness(change from baseline in disability at 6 weeks)
  • Respiratory Muscle Strength(change from baseline in disability at 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze YALCINKAYA

Principal Investigator

Dokuz Eylul University

研究点 (6)

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