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The purpose of this study is to evaluate the clinical results in lower cervical range of motion, size deep muscles, endurance, craniovertebral angle and cervical propioception 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.
Neck pain is one of the major public health problems, which has a great impact on people's lives, with high prevalence and recurrence rate. Cervical vertebral column is heavily dependent on the muscles for its physical support and activities. There are increasing evidences to support that cervical muscles may impair in patients with neck disorders. Training protocols can help to improve pain, cervical function, posture and cross-sectional area. However, there are no training protocols in subjects with strength deficit of deep cervical muscles, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training protocol with the cervical device for treatment (CDAT). | Experimental | Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment. |
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| Conventional training protocol- | Active Comparator | Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol. |
|
| Control Group | No Intervention | Subject continues with activities of daily living. Does not receive deep cervical muscle training. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training protocol with the cervical device for treatment (CDAT). | Other | Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Deep neck flexor endurance Test. | The Chin Tuck Neck Flexion Test is an assessment technique intended to determine the endurance of the deep cervical flexors. | Baseline and 6 weeks, 10 weeks, 14 weeks |
| Neck extensor muscle endurance Test | Mean change from baseline in neck extensor muscle endurance Test after 6 weeks, 10 weeks and 14 weeks. The examiners assess the endurance of deep cervical extensor muscle. | Baseline and 6 weeks, 10 weeks, 14 weeks |
| Measurement of Cervical Multifidus and Longus Colli Muscle size. | The examiners assess these deep muscles with ultrasound after 6 weeks, 10 weeks and 14 weeks. | Baseline and 6 weeks, 10 weeks, 14 weeks |
| Physical activity enjoyment Scale (PACES) | The examiners assess participant satisfaction with cervical deep muscle training. This scale measures enjoyment during physical activity through 16 items, which are preceded by the phrase "When I am active..." This instrument measures enjoyment and bipolar enjoyment, through statements such as "I enjoy it", "I'm bored", "It's very exciting", and "I don't like it". The answers will be collected on a Likert scale from 1 (totally disagree) to 5 (totally agree). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pilar Pardos-Aguilella | UicCatalunya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Élite Fisioterapia, MarÃa Montessori 2. | Zaragoza | Zaragoza | 50018 | Spain |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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This will be a randomized controlled trial with 3 different groups
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| Conventional training protocol | Other | Endurance training program of deep cervical flexors and deep cervical extensors with conventional training protocol. |
|
| Baseline and 6 weeks, 10 weeks, 14 weeks |
| Neck Pain | Mean change from baseline in neck pain (VAS) after 6 weeks, 10 weeks and 14 weeks. The examiners assess the self-perceived intensity of neck pain using the Visual Analogue Scale (VAS). The VAS is designed to measure pain intensity. It consists of a 10 cm horizontal line where the patient marks the point that best represents their pain, ranging from 0 (no pain) to 10 (worst imaginable pain). The measure is designed to be completed directly by the patient. Scores are recorded in centimeters, with higher values indicating greater pain intensity. | Baseline and 6 weeks, 10 weeks, 14 weeks |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |