Effectiveness of a Training Protocol With the Cervical Device in Subjects With Deep Cervical Muscle Strength Deficit in Cervical Range of Motion, Muscle Endurance and Neck Disability.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Neck Disability Index
研究概览
简要总结
The purpose of this study is to evaluate the clinical results produced by a training protocol with the new device for cervical treatment (CDAT) and the conventional training protocol (CT) versus a control group (C) in subjects with cervical deep muscle strength deficit and mild neck disability.
详细描述
Cervical pain is in many cases a decrease in the quality of life.The cervical spine is the most mobile region of the spine which also must be strong enough in order to support the weight of the skull. Deficits in deep cervical muscle strength are related to different clinical conditions: cervicogenic dizziness, cervical radiculopathy, cervical mechanical-chronic, cervical pain and cervical instability. Training protocols can help to improve pain, cervical function, posture and cross-sectional area. However, there are no training protocols in subjects with mild disability and strength deficit of the deep cervical muscle, including deep neck extensor and flexor muscles. The cervical device treatment (CDAT) allows us to train the cervical flexor and extensor muscle in a simple and comfortable way.
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 (Outcomes Assessor)
盲法说明
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
- •Deep flexor strength deficit in craniocervical flexion test.
- •Deep extensor strength deficit in neck extensor muscle endurance test.
- •≤ 14 score in Neck disability Index.
排除标准
- •Have received cervical treatment during the last six month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).
- •Have received cervical manual therapy treatment during the last six month.
- •A history of cervical trauma or surgery during the last year.
- •Chronic neck pain occurring during the last six months (intensity, visual analogue scale >3/10, frequency > 2 days/week, duration >3 hours/day).
研究组 & 干预措施
Experimental: Training protocol with the cervical device for treatment (CDAT).
Endurance and stabilization training program of deep cervical flexors with the cervical device for treatment.
Endurance and stabilization training program of deep cervical extensors with the cervical device for treatment.
干预措施: Training protocol with the device cervical for treatment (CDAT) (Other)
Conventional training protocol:
Endurance and stabilization training program of deep cervical flexors with conventional protocol.
Endurance and stabilization training program of deep cervical extensors with conventional protocol.
干预措施: Conventional training protocol (Other)
Control Group
Subject continues with activities of daily living. Does not receive deep cervical muscle training.
结局指标
主要结局
Neck Disability Index
时间窗: Baseline and 6 weeks, 10 weeks, 14 weeks
Mean change from baseline in Neck Disability Index (NDI) (Neck Function) after 6 weeks , 10 weeks and 14 weeks. The examiners assess the self-perceived disability from neck pain using the NDI. The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. The measure is designed to be given to the patient to complete. Item scores range from 0 (no disability) to 5 (total disability), with the minimum score is 0 (no disability) and maximum score of 50 (complete disability).
Craniocervical flexion test
时间窗: Baseline and 6 weeks, 10 weeks, 14 weeks
The examiners assess the strength of deep cervical flexors with craniocervical flexion test.
GLOBAL RATING OF CHANGE SCALE (GROC)
时间窗: Baseline and 6 weeks, 10 weeks, 14 weeks
The examiners assess self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores after 6 weeks, 10 weeks and 14 weeks. The GROC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter. Item scores range from - 7 (A very great deal worse) to + 7 A very great deal better.
Cervical Spine range of motion
时间窗: Baseline and 6 weeks, 10 weeks, 14 weeks
Mean change from baseline in Lower and Upper Cervical Spine Range of Movement (ROM) after 6 weeks , 10 weeks and 14 weeks. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Cervical flexion, extension, right/left sidebending, right/left rotation will be evaluated. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Upper cervical flexion, upper cervical extension and flexion rotation test will be evaluated. Flexion rotation test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32.
次要结局
未报告次要终点
研究者
Pilar Pardos Aguilella
Collaborating Teacher
Universitat Internacional de Catalunya