Aim: To compare the effects of somatosensory exercise vs endurance-strength exercise on the deep cervical flexor muscles on pain and perceived disability in patients with chronic neck pain. Study design: Protocol of a clinical trial, controlled, parallel and a blinded assessor. Population: Subjects aged 18 to 65 years with neck pain of 3 or more months of evolution.
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 60 subjects with nonspecific chronic neck pain will be selected and randomly assigned into two intervention groups. The first group will perform a somatosensory exercise program and a second group will perform activation and endurance-strength exercises of the deep cervical flexors. The duration of the intervention will be 8 weeks, with 6 sessions of physical therapy and daily home exercise. The variables pain, pressure pain threshold, disability, endurance-strength, proprioception, quality of life, kinesiophobia, quality of sleep and depression will be analyzed. Measurements will be taken pre-treatment, post-treatment and a follow-up at 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
A somatosensory training and an endurance-strength training protocol
University of Alcalá
Alcalá de Henares, Madrid, Spain
Pain change
To assess pain, the Visual Analogue Scale will be used, which consists of a 10-centimeter horizontal line, at whose ends is the maximum expression of a symptom.
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Disability change
Disability will be assessed using the validated Spanish version of the Cervical Disability Index. Its range score is 0-50, higher values mean greater disability.
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Pressure Pain Threshold change
To assess the Pressure Pain Threshold, a analog pressure algometer will be used. The pressure will be performed bilaterally on the levator scapulae, upper trapezius, splenius capitis and sternocleidomastoid.
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Endurance of craniocervical flexion change
The isometric endurance of the deep flexor muscles of the neck will be measured with the Craniocervical Flexion Test, using a pressure biofeedback.
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Proprioception change
The proprioception of the head and neck in space will be evaluated using the Cervical Joint Positioning Error Test.
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Kinesiophobia change
The patients' level of fear of movement will be evaluated using the Tampa Scale for Kinesiophobia. Range score is 11-44, higher values mean greater fear of injury.
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Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Sleep quality change
To assess sleep quality we will use the Pittsburgh Sleep Quality Index, using the Spanish version. Range score is 0-21, higher values mean worse outcome.
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Quality of life change
Quality of life will be assessed with the 12-Item Short Form Survey, second version (SF-12v2), using its Spanish version. This questionnaire is made up of 12 items which measure both physical and mental items. Range score is PCS 24-56,6 and MCS 19-60,8, higher values mean higher quality of life.
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Depression change
To assess depression, the Beck Depression Inventory in its second edition (BDI-II), in its Spanish version, will be used. Range score is 0-63, higher values mean worse outcome.
Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.