Feasibility and Impact of a Tele-rehabilitation Program in Patients With Chronic and Non-specific Neck Pain

Study Overview
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Brief Summary
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Chronic neck pain has a high prevalence in developed countries, being one of the main causes of years lived with disability and deterioration of the quality of life. Telerehabilitation is presented as a resource capable of favoring, with its development and implementation, the transition to a universal and quality health service. The main objective of the study is to assess the change in disability produced by a telerehabilitation program (applied in the intervention group) in patients with chronic and nonspecific neck pain compared to the recommendation of home exercises (control group). The study that will be carried out will be a controlled and randomized clinical trial (ECCA), single-blind, longitudinal and prospective with two groups (intervention group and control group). The main study variables that are intended to be analyzed pre and post intervention are disability, quality of life, pain, adherence, and depression and anxiety. The study will take place between June 2020 and May 2021 in specialized physiotherapy clinics.

Official Title
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Feasibility and Impact of a Tele-rehabilitation Program in Patients With Chronic and Non-specific Neck Pain

Conditions
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Chronic Non-specific Neck Pain

Intervention / Treatment
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* Other: MANUAL THERAPY
* Other: THERAPEUTIC EXERCISE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People between 18 and 65 years of age Neck pain of more than 3 months of evolution Access and knowledge in the use of the internet Complete the informed consent Exclusion Criteria: Previous trauma to the cervical region (such as whiplash) Neck surgery Osteoporosis Arthritis Cervical radiculopathy associated with externalized cervical hernia Vertigo or vertebrobasilar insufficiency Cancer Vertebral fracture Fibromyalgia Cognitive impairment Psychiatric disorders.

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual therapy and a telerehabilitation program<br>In the experimental group, an intervention based on manual therapy and a telerehabilitation program based on exercises will be carried out. The investigators will apply manual therapy for ten minutes a week based on cervical mobilizations and suboccipital inhibitions. The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need. | Other: MANUAL THERAPY<br>* The investigators will apply manual therapy for ten minutes a week, for 8 weeks, based on cervical mobilizations and suboccipital inhibitions.<br>Other: THERAPEUTIC EXERCISE<br>* The exercises recommendations will be based on a simulation of the exercises in the same session of the manual therapy of each week, helped by the physiotherapist. The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need.<br>|
| Active Comparator: Manual therapy and recommendations for home exercises<br>In the control group, the same manual therapy intervention and recommendations for home exercises will be applied. This exercises recommendations will be based on a simulation of the exercise in the same session of the manual therapy of each week. | Other: MANUAL THERAPY<br>* The investigators will apply manual therapy for ten minutes a week, for 8 weeks, based on cervical mobilizations and suboccipital inhibitions.<br>Other: THERAPEUTIC EXERCISE<br>* The exercises recommendations will be based on a simulation of the exercises in the same session of the manual therapy of each week, helped by the physiotherapist. The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in disability | Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability). | Baseline, 8 weeks and 2 month after intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the health-related quality of life | Using the Short Form 12 Health Survey (SF-12). It is made up of a subset of 12 items from the SF-36 (physical function, social function, physical role, emotional role, mental health, vitality, bodily pain and general health), including 1-2 items from each of the 8 scales of the SF-36. | Baseline, 8 weeks and 2 month after intervention. | 
| Changes in depression and anxiety | Using the Hospital Anxiety and Depression Scale (HADS). It consists of two series of seven questions (a total of 14 items), one represents the anxiety subscale and the other the depression. Each item is valued according to a four-point frequency scale that ranges from 0 to 3 (0 = I always do it; 1 = not so much; 2 = definitely not that much; 3 = not at all). | Baseline, 8 weeks and 2 month after intervention. | 
| Changes in Kinesiophobia | Using the Tampa Scale for Kinesiophobia-11 (TSK-11), self-report of 17 items that address fear of movement and injury relapse. Four of the items are negatively written and scored inverse (4, 8, 12 and 16). The scores are added together to obtain a total score, with higher values reflecting greater kinesiophobia. | Baseline, 8 weeks and 2 month after intervention. | 
| Changes in the pain: Visual Analog Scale (VAS) | Using the Visual Analog Scale (VAS). Each item is scored 0-10 (0= no pain; 10= the major pain that the patient can imagine) yielding a total between 0 and 10. | Baseline, 8 weeks and 2 month after intervention. | 
| Adherence to treatment | Using a record book of the completion of the treatment program, where the activity carried out will be reflected. | At 4 and 8 weeks of treatment | 
| Pressure pain threshold | Using a digital pressure algometer at a speed of 1 kg / cm2 / s perpendicular to the skin surface. The patient will be required to immediately indicate when the sensation of pressure (kg / cm2) becomes a sensation of pain, and thus terminate the compression. | Baseline, 8 weeks and 2 month after intervention. |