Effectiveness of Massage Therapy With Active Component and Therapeutic Exercise in Cervical Pain

Study Overview
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Brief Summary
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It is an interventional study that proves the eficacy of the manual therapy with active manual therapy and combined with exercise in cervical pain.

Detailed Description
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The study will be divided in two different groups: A control group (group A) : they will receive a treatment with manual therapy and physical exercise. An experimental group (group B) : they will receive the previous treatment, but also the pacient's do active muscle active contraction. The exercise is compound by a home program of several exercises with diferent difficulties. The contraction will consist on a combination of concentric and isometric work. being the patient's pain threshold the one that will guide us to the choice of the predominance of concentric or isometric contraction . Both groups will be joined by a five-minute work on pain education.

Official Title
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Effectiveness of Massage Therapy With Active Component and Therapeutic Exercise in Cervical Pain

Conditions
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Neck Pain, Chronic Pain

Intervention / Treatment
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* Other: Manual therapy active
* Other: Manual therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: accept to participate in the study, through informed consent subjects with chronic nonspecific neck pain lasting equal to or more than 3 months Exclusion Criteria: Present neck pain caused by serious pathology such as: inflammatory, congenital, infectious, metabolic and neoplastic diseases. Cervical pathology of traumatic origin with less than 6 months of evolution. Rheumatic diseases. Neck pain with neurological signs such as: radiculopathy and myelopathy. Previous surgery of the cervical spine. Pregnancy. Have received physiotherapeutic treatment in the cervical region during the month prior to the inclusion of the study. Have the intention of receiving other physiotherapeutic treatments different from the one proposed during the study period. Present serious mental disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: blind
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active<br>this is the group that does a treatment with active movement, a program of pain education and a program of home exercise. | Other: Manual therapy active<br>* massage or ischemic compression with active contraction, tha will be isometric or concentric.<br>|
| Active Comparator: non active<br>this is the group that does a treatment without active movement, a program of pain education and a program of home exercise. | Other: Manual therapy<br>* massage or isquemic compression without contraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neck 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, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain perception | Using the Visual Analog Scale (VAS) from 0 to 10 | Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement. | 
| Change in Range of motion (ROM) | Using a inclinometer | Baseline, 1 month (primary timepoint) and 2 months after intervention commencement. | 
| Change in craniocervical flexion | Using the craniocervical flexion test (CCFT) we make a evaluation of the strength of the deep cervical flexor muscles. From 22 to 30 mmHg of preasure. | Baseline, 1 month (primary timepoint) and 2 months after intervention commencement. | 
| Change in kinesophobia | 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, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement. | 
| Change in Catastrophism | Using the Pain catastrophizing scale from 0 to 56 | Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement. | 
| Change in Sleep Quality | Using the Pittsburgh Sleep Quality Index | Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neck pain, exercise, Endurance, Training, Intervention