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临床试验/NCT04691024
NCT04691024已完成不适用

Effects of Remotely Applied Spinal Stabilization Exercises on Functional Level and Muscle Architecture in Individuals With Chronic Neck Pain

Hacettepe University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年1月25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
31
试验地点
1
主要终点
Evaluation of Functional Capacity Level with Back Performance Scale

研究概览

简要总结

Neck pain is a problem that recurs at certain stages of life and can affect approximately half of the population. A problem in the cervical region can cause problems such as pain and limitation in the surrounding joints. Doing a job with functional activity or fulfilling professional requirements can aggravate neck pain. As a result, anatomical, physiological and psychological systems emerge as factors affecting pain. Determining the disability of the individual and the effectiveness of rehabilitation can be demonstrated with functional capacity assessment. It is stated that in individuals with chronic neck pain, architectural features such as functional cross-sectional area of deep neck muscles and reduction of muscle thickness change. Muscle preservation may increase as pain increases, and more protection too; Limitations can further increase conditions such as pain. In addition to the problem being only in the neck region, the whole spine posture may change, and the lumbar region muscles may also weaken by considering the spine as a whole. It is stated that the muscular architectural properties of the cervical and lumbar region, which play an important role in the posture of the spine in individuals with chronic neck pain, can be improved with exercise. During the 2020 years' pandemic process, the time spent at home, the use of mobile devices, the duration of working at home on a desk increased, and increases in spine pain reported to professionals were observed. The fact that family members are at home has increased the workload of the home and the frequency of performing functional activities has increased. It is reported that the distance between physiotherapists and patients should be at least 2 meters in clinics due to the risk of contamination. As a result, the pandemic process has brought the remote exercise management, tele-rehabilitation process to the fore for physiotherapists and the society. With spinal stabilization exercises, the functional level and muscle architecture of individuals with chronic neck pain can be associated with architectural changes in the spinal muscles. As a result of the 2020 years' pandemic, it is not known whether remote exercise and face-to-face exercises will have different effects on clinical variables, functional activities, muscle architecture, together with difficulties in accessing clinics. The aim of the study is to investigate the effects of remote spinal stabilization exercises on functional level and muscle architecture on individuals 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
Single (Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Having neck pain for at least 3 months,
  • •Between the ages of 18-55,
  • •Being literate,
  • •Individuals who are capable of understanding exercises (Montreal Cognitive Assessment Scale (MOCA) total score> 21) will be included in the study.

排除标准

  • •Cervical radiculopathy, thoracic outlet syndrome,
  • •Malignant condition,
  • •Having systemic diseases such as neurological, psychological, cardiovascular and loss of function due to these diseases,
  • •A history of surgery in the spine and upper extremity, including the cervical region, in the last 1 year period,
  • •Fracture in the spine and upper extremity, including the cervical region, with a history of inflammation,
  • •Acute infection,
  • •Continuing another rehabilitation program,
  • •Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

研究组 & 干预措施

Treatment Group

Experimental

Remotely Exercises 3 times a week, 8 weeks remotely (with video) spinal stabilization exercises

干预措施: Exercise (Other)

Control Group

Other

Face to Face Exercises 3 times a week, 8 weeks face to face (in clinic) spinal stabilization exercises

干预措施: Exercise (Other)

结局指标

主要结局

Evaluation of Functional Capacity Level with Back Performance Scale

时间窗: 10 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks

The back performance test (Back Performance Scale) is a test that evaluates the effectiveness of each activity that includes 5 different activities (socks test, gathering test, righting test, fingertip-floor test, carrying test). The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.

Evaluation of Functional Capacity Level with Functional Capacity Assessment Test

时间窗: 20 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks

Functional capacity assessment evaluates the effectiveness (time to completion, weight it can handle) of each activity that includes different activities for neck pain. The test includes the activities of "repetitive reaching out, lifting objects overhead, working overhead". The validity and reliability of the Functional Capacity Assessment Test in individuals with chronic neck pain has been shown. The time individuals can complete the tests will be recorded.

Evaluation of Muscle Thickness with Ultrasonography

时间窗: 15 minutes, through study completion, an average of 8 weeks, Change from Baseline Muscle Thickness at 8 weeks

Ultrasonography is used to evaluate the architectural properties of the muscle (such as thickness) in chronic painful musculoskeletal problems such as neck-back pain. Muscle architecture measurements with ultrasound will be carried out before and after the exercise program by the specialist radiology doctor who is blind to the results of the study using 3.5-10 MHz convex and linear probes (Soundcam Mobile Ultrasound Device). Within the scope of our study, the muscle thickness of the spinal muscles will be evaluated in the resting position.

Evaluation of the Functional Cross Sectional Area with Ultrasonography

时间窗: 15 minutes, through study completion, an average of 8 weeks, Change from Baseline the FCSA at 8 weeks

Ultrasonography is used to evaluate the architectural properties of the muscle (such as he Functional Cross Sectional Area (FCSA)) in chronic painful musculoskeletal problems such as neck-back pain. Muscle architecture measurements with ultrasound will be carried out before and after the exercise program by the specialist radiology doctor who is blind to the results of the study using 3.5-10 MHz convex and linear probes (Soundcam Mobile Ultrasound Device). Within the scope of our study, the muscle FCSA of the spinal muscles will be evaluated in the resting position.

次要结局

  • Evaluation of pain severity(5 minutes, through study completion, an average of 8 weeks, Change from Baseline pain severity at 8 weeks)
  • Evaluation of neck awareness(5 minutes, through study completion, an average of 8 weeks, Change from Baseline neck awareness at 8 weeks)
  • Evaluation of Exercise Adherence Assessment: Exercise Adherence Rating Scale (EARS) (EUAS)(5 minutes, through study completion, an average of 8 weeks, Change from Baseline Exercise Adaptation Assessment at 8 weeks)
  • Evaluation of quality of life(5 minutes, through study completion, an average of 8 weeks, Change from Baseline quality of life at 8 weeks)
  • Evaluation of disability(5 minutes, through study completion, an average of 8 weeks, Change from Baseline disability at 8 weeks)
  • Evaluation of Difficulty of Functional Activities and Exercise Program Satisfaction with Visual Analog Scale(5 minutes, through study completion, an average of 8 weeks, Change from Baseline Difficulty of Functional Activities and Exercise Program Satisfaction at 8 weeks)
  • Evaluation of kinesiophobia(5 minutes, through study completion, an average of 8 weeks, Change from Baseline kinesiophobia at 8 weeks)

研究者

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

Dilara Onan

Research Assistant, Physiotherapist

Hacettepe University

研究点 (1)

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