Effects of Instrumental and Manipulative Techniques for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the effectiveness between the suboccipital inhibition technique, the suboccipital inhibition carried out with the INYBI instrument and the suboccipital inhibition with the INYBI plus the upper cervical manipulation, all in patients with chronic mechanic cervicalgia, and to determine which of these techniques is the most effective in the variables studied. In order to do so, 96 subjects participated in the study, being assigned to the 3 intervention groups. We expected the combined treatment (INYBI instrument + upper cervical manipulation) to be the one to produce the best results.

Official Title
-----------------
Effects of Instrumental, Manipulative and Soft Tissue Approaches for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain. A Randomized Controlled Trial

Conditions
-----------------
Chronic Mechanical Neck Pain

Intervention / Treatment
-----------------
* Other: suboccipital inhibition
* Other: INYBI
* Other: INYBI + upper cervical manipulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants aged between 18 and 40 all diagnosed with chronic mechanic cervical pain with an evolution of at least 3 months and who show pain that increases with maintained postures, during movement and during spinal muscles palpation. Exclusion Criteria: participants that can't read and/or fill in the informed consent, either due to a language and/or cognition alteration or age-related factors. subjects with psychological pathologies, such as hysteria, depression or anxiety. subjects that have received a manual treatment two months before the beginning of the clinical trial. subjects who have been recommended by a physician or an anesthetist to receive any type of analgesic, anti-inflammatory or neuromodulator medication, such as antidepressants, antiepileptics and benzodiazepines. If the patient took in this type of medication in an occasional way 72 hours before the beginning of the study, he/she could participate. the treatment and assessment techniques will be avoided if: fear to vertebral manipulation in the upper cervical area or positive Klein test and other integrity test of the vertebral artery, positive cervical instability test and positive Spurling test (foraminal compression test).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: suboccipital inhibition technique group<br> | Other: suboccipital inhibition<br>* The therapist will seat at the patient's head height and place his second, third, fourth and fifth fingertips'over the patient's suboccipital area during a 10-minute period.<br>|
| Experimental: INYBI group<br>Participants in this group will be treated with the INYBI, an instrument designed for treating the suboccipital area, in a more precise way than the manual technique. | Other: INYBI<br>* The therapist will place the INYBI at the suboccipital area, specifically placing the fingers of the instrument at the lower border of the occipital. If needed, a rolled towel will be placed behind the INYBI, in order to maintain the physiological lordosis, checking out that the patient doesn't make a cervical extension. Then the therapist will press the vibration button and turn it off after 10 minutes. All patients will receive the treatment with the INYBI's hardest head with a 50 HZ frequency.<br>|
| Experimental: combined treatment group<br>Participants in this group will be first treated with the INYBI and then receive an upper cervical manipulation | Other: INYBI + upper cervical manipulation<br>* The participant will also be treated with the INYBI during a 10-minute period. After that, the therapist will carry out the upper cervical manipulation technique. Keeping the patient's head on an upper cervical flexion position, the therapist will turn his/her head to the maximum possible rotation, always maintaining its longitudinal axis. Once this is done, a high velocity and short articular amplitude manipulation in rotation will be carried out<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in patients' cervical functionality between baseline and follow-up period. | cervical functionality is measured with the Neck Disability Index | Baseline and two weeks after the second intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in patients' cervical mobility between baseline and follow-up periods. | The movements that will be measured with the CROM® are: flexion, extension, right and left rotation, right and left side-bending. | Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention. | 
| Changes in patients' pressure pain threshold between baseline and follow-up periods. | The pressure pain threshold will be measured with an algometer (Mechanical Algometer Pain Test® de Wagner Instrument, USA) in the suboccipital and trapezius muscles (both left and right). | Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention. | 
| Changes in patients' pain due to movement between baseline and follow-up periods. | The movements that will be measured with the visual analogue scale (VAS) are: flexion, extension, right and left rotation, right and left side-bending. | Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention. |