Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
weight |
Record of information provided by the patient about sex, age, weight, height and body weight in kilograms (kg) |
baseline |
|
Other |
height |
height in meters (m) |
baseline |
|
Other |
body mass index |
weight and height will be combined to report body mass index in kg / m ^ 2 |
baseline |
|
Primary |
Neck pain intensity |
Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct. |
baseline |
|
Primary |
Neck pain intensity |
Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct. |
at one month |
|
Primary |
Neck pain intensity |
Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct. |
at two months |
|
Primary |
Neck function |
Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50. |
baseline |
|
Primary |
Neck function |
Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50 |
at one month |
|
Primary |
Neck function |
Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50 |
at two months |
|
Secondary |
temporomandibular pain intensity |
Numeric Pain Rating Scale to assess the intensity of the temporomandibular pain intensity. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct. |
baseline |
|
Secondary |
temporomandibular pain intensity |
Numeric Pain Rating Scale to assess the intensity of the temporomandibular pain intensity. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct. |
at one month |
|
Secondary |
temporomandibular pain intensity |
Numeric Pain Rating Scale to assess the intensity of the temporomandibular pain intensity. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct. |
at two months |
|
Secondary |
Temporomandibular joint function |
using Fonseca Anamnestic Index. Its structure consists of 10 questions with a three-point scale (0=no, 5= sometimes and 10= yes), with the overall score of the test ranging from 0 to 100. The FAI evaluates the presence or absence of symptoms caused by TMDs and their severity (mild, moderate and severe). |
baseline |
|
Secondary |
Temporomandibular joint function |
using Fonseca Anamnestic Index. Its structure consists of 10 questions with a three-point scale (0=no, 5= sometimes and 10= yes), with the overall score of the test ranging from 0 to 100. The FAI evaluates the presence or absence of symptoms caused by TMDs and their severity (mild, moderate and severe). |
at one month |
|
Secondary |
Temporomandibular joint function |
using Fonseca Anamnestic Index. Its structure consists of 10 questions with a three-point scale (0=no, 5= sometimes and 10= yes), with the overall score of the test ranging from 0 to 100. The FAI evaluates the presence or absence of symptoms caused by TMDs and their severity (mild, moderate and severe). |
at two months |
|
Secondary |
Health Related Quality of life |
12-Item Short-Form Health Survey (SF-12): is a simple and quick questionnaire compared to its predecessor, the SF-36 that is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers. The final result of the test is obtained in a more exact way by means of a statistical processing instrument that provides the value of the physical and mental summary scores with values between 0 and 100. |
baseline |
|
Secondary |
Health Related Quality of life |
12-Item Short-Form Health Survey (SF-12): is a simple and quick questionnaire compared to its predecessor, the SF-36 that is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers. The final result of the test is obtained in a more exact way by means of a statistical processing instrument that provides the value of the physical and mental summary scores with values between 0 and 100. |
at one month |
|
Secondary |
Health Related Quality of life |
12-Item Short-Form Health Survey (SF-12): is a simple and quick questionnaire compared to its predecessor, the SF-36 that is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers. The final result of the test is obtained in a more exact way by means of a statistical processing instrument that provides the value of the physical and mental summary scores with values between 0 and 100. |
at two months |
|
Secondary |
Headache impact in quality of life. |
The Headache Impact Test (HIT-6) is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are "never", "rarely", "sometimes", "very often" and "always". The numerical result is the sum of the answers. |
baseline |
|
Secondary |
Headache impact in quality of life |
The Headache Impact Test (HIT-6) is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are "never", "rarely", "sometimes", "very often" and "always". The numerical result is the sum of the answers. |
at one month |
|
Secondary |
Headache impact in quality of life |
The Headache Impact Test (HIT-6) is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are "never", "rarely", "sometimes", "very often" and "always". The numerical result is the sum of the answers. |
at two months |
|
Secondary |
Dizziness |
Dizziness measured with Dizziness Handicap Inventory: is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders. Each dimension corresponds to different questions distributed randomly throughout the test. The functionality questions correspond to items 3, 5, 6, 7, 12, 14, 16, 19 and 24, the emotional questions correspond to items 2, 9, 10, 15, 18, 20, 21, 22 and 23, and the questions on the physical dimension correspond to items 1, 4, 8, 11, 13, 17 and 25. |
baseline |
|
Secondary |
Dizziness |
Dizziness measured with Dizziness Handicap Inventory: is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders. Each dimension corresponds to different questions distributed randomly throughout the test. The functionality questions correspond to items 3, 5, 6, 7, 12, 14, 16, 19 and 24, the emotional questions correspond to items 2, 9, 10, 15, 18, 20, 21, 22 and 23, and the questions on the physical dimension correspond to items 1, 4, 8, 11, 13, 17 and 25. |
at one month |
|
Secondary |
Dizziness |
Dizziness measured with Dizziness Handicap Inventory: is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders. Each dimension corresponds to different questions distributed randomly throughout the test. The functionality questions correspond to items 3, 5, 6, 7, 12, 14, 16, 19 and 24, the emotional questions correspond to items 2, 9, 10, 15, 18, 20, 21, 22 and 23, and the questions on the physical dimension correspond to items 1, 4, 8, 11, 13, 17 and 25. |
at two months |
|