Comparison of Somatosensory Versus Endurance-strength Exercise in Patients With Chronic Neck Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Somatosensory Exercise Versus Endurance-strength Exercise in Patients With Chronic Neck Pain: a Randomized Clinical Trial

Conditions
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Neck Pain

Intervention / Treatment
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* Other: Therapeutic exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of age between 18 and 65 years Neck pain of 3 or more months of evolution Exclusion Criteria: Cervical Disability Index less than 15/50 Infection Oncological processes Neck or arm surgery Neck or arm trauma Positive neurological signs Rheumatic diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A single center, parallel, randomized, blinded rater, controlled clinical trial will be conducted. The 25 requirements proposed by the CONSORT declaration will be followed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somatosensory training<br>It consists of head relocation exercises, eye tracking, gaze stability and eye-head coordination. It requires the use of special material, the pupillary glasses allow the gaze to be fixed by restricting peripheral vision and the laser pointer provides visual feedback on the positioning of the head. | Other: Therapeutic exercises<br>* A somatosensory training and an endurance-strength training protocol<br>|
| Experimental: Endurance-strength training<br>It consists of low-load training of the craniocervical flexor muscles. This exercise is specific for the deep cervical flexor muscles, while seeking minimal activation of the superficial flexor muscles. This training consists of 5 phases, starting with a pressure of 20 mmHg, progressively increasing 2 mmHg in each phase. | Other: Therapeutic exercises<br>* A somatosensory training and an endurance-strength training protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neck pain, chronic pain, therapeutic exercise, proprioception, motor control