The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the effects of vertebral manipulation and pain education on subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be selected and allocated randomly into 2 groups: vertebral manipulation group and pain education group.

Official Title
-----------------
The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Other: Spinal Manipulation
* Other: Pain Education
* Other: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Main complaint of Neck Pain for at least six (6) months; Score of at least 10 points in NDI (Neck Disability Index); Pain and / or restriction of cervical movements; Pain reported at least 3 points on the NPRS (Numeric Pain Rating Scale); The definition of the term Neck Pain follows the classification of TFNP. Exclusion Criteria: Previous history of rheumatic disease, cervical myelopathy, tumors, vertebrobasilar insufficiency, central or peripheral neurological disorders; History of major trauma, fracture or surgery in the neck, shoulder and/or upper limb; Signs of nerve root compression as important muscle weakness affecting the upper limbs, reduction, loss or increase of biceps and triceps reflexes, decreased sensation in the dermatomes of the upper limb; Red flags contraindicating spinal manipulation.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Manipulation<br>High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region and pain education. The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes. | Other: Spinal Manipulation<br>* High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region<br>* Other names: Vertebral Manipulation;Other: Pain Education<br>* Subjects will receive pain education based in biopsychosocial approach<br>* Other names: Pain Neuroscience Education;|
| Sham Comparator: Pain Education<br>Pain education and a simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes. The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes. | Other: Pain Education<br>* Subjects will receive pain education based in biopsychosocial approach<br>* Other names: Pain Neuroscience Education;Other: Sham<br>* A simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Intensity of pain will be measured by the numeric pain rating scale (NPRS) | 4 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokines | Level of concentration of pro and anti-inflammatory cytokines | 4 weeks after randomization | 
| Pressure Pain Threshold | Pressure pain Threshold will be measured with a digital algometer | 4 weeks and 3 months after randomization | 
| Disability | Disability will be measured by the Neck Disability Index (NDI) | 4 weeks and 3 months after randomization | 
| Fear Avoidance Beliefs | Fear Avoidance will be measured by the Fear Avoidance Beliefs Questionnaire (FABQ) | 4 weeks and 3 months after randomization | 
| Health-related Quality of Life | Quality of Life will be measured by the 12-Item Health Survey (SF-12) | 4 weeks and 3 months after randomization | 
| Kinesiophobia | Kinesiophobia will be measured byTampa Scale for Kinesiophobia | 4 weeks and 3 months after randomization | 
| Pain Intensity | Intensity of pain will be measured by the numeric pain rating scale (NPRS) | 3 months after randomization |