Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change from baseline Self-reported neck pain intensity in neutral head position at 6 months. |
Current pain intensity in neutral head position, as assessed with a numeric pain rating scale (NPRS).The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain. |
From Baseline to after treatment,with a 3-month and a 6- month follow up |
|
Primary |
Change from baseline self-reported neck pain intensity associated to the most painful cervical rotation at 6 months |
Current pain intensity during the most painful passive cervical rotation, as assessed with a numeric pain rating scale (NPRS).The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain. |
From Baseline to after treatment, with a 3-month and a 6- month follow up. |
|
Primary |
Change from baseline mean self-reported neck pain intensity during the last week at 6 months. |
The subject is asked about the mean pain intensity during the previous week, as assessed with a numeric pain rating scale (NPRS).The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain. |
From Baseline to after treatment,with a 3-month and a 6- month follow up. |
|
Primary |
Change from baseline worst self-reported neck pain intensity in the last 24 hours at 6 months. |
The subject is asked about the highest neck pain intensity in the last 24 hours, as assessed with a numeric pain rating scale (NPRS).The subject is asked about theThe Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain. |
From Baseline to after treatment, with a 3-month and a 6- month follow up. |
|
Secondary |
Change from baseline self-reported neck related disability at 6 months. |
This will be assessed with the Neck disability index (NDI). The neck disability index is a condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each section is scored on a 0 to 5 rating scale, in which zero means no disability and 5 means the worst imaginable disability. The final score can range from 0 to 50 points (raw score) or from 0% to 100%, with 0 points or 0% denoting no activity limitations, and 50 points or 100% denoting complete activity limitation. |
From Baseline to after treatment, with a 3-month and a 6- month follow up. |
|
Secondary |
Change from baseline pressure pain sensitivity in neck shoulder muscles and brachial plexus nerve trunks at 6 months |
Pressure pain thresholds, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer (model FPX 25, Wagner Instruments, Greenwich, CT, USA), with a 1-cm2 contact rubber probe. This outcome will be assessed over the upper trapezius, levator scapulae, anterior scalene and splenius cervicis muscles. The tibialis anterior muscle will be used as a remote location. Likewise, the pressure pain sensitivity will be evaluated over the median and cubital nerves. |
From Baseline to after treatment, with a 3-month and a 6- month follow up. |
|
Secondary |
Global Rating of Change. |
A 15-point numeral global rating of change scale will be used. This scale ranges from -7 (very much worse), through 0 (unchanged) to +7 (completely recovered). This is a patient self-reported scale that assesses whether the patient condition has gotten worse, better, or stayed the same. Participants are asked to quantify the magnitude of that change, whether positive or not. |
After treatment, with a 3-month and a 6- month follow up. |
|
Secondary |
Change from baseline muscle viscoelastic properties (muscle tone and stiffness) at 6 months |
The mechanical firmness of skeletal muscle in the absence of active contraction is related to the viscoelastic properties of the muscle tissue itself at rest, which can be quantified using myotonometry. The muscle tone and stiffness will be assessed over the upper trapezius, levator scapulae, anterior scalene, splenius cervicis and the tibialis anterior as a remote location. For this purpose, we will use a Myoton PRO (Myoton SA, Tallinn, Estonia) device. The MyotonPro is a low cost hand-held tool that uses multiple short impulses through a testing probe to measure several muscle properties, e.g., tone, stiffness, elasticity, and creep. The reliability and validity of the MyotonPro is well supported in healthy individuals, and in different musculoskeletal conditions. |
From Baseline to after treatment, with a 3-month and a 6- month follow up. |
|
Secondary |
Change from baseline left-Right discrimination ability at 6 months. |
The neck related left-right discrimination ability will be collected through the use of the Recognise app (2016 Noigroup, Adelaide, Australia, http://www.noigroup.com). We will use the app specific for the Neck version, using a Huawei P10 (5.15 "mobile phone, Huawei Technologies Co., Shenzhen, Guangdong.) Left / right discrimination can be defined as the process of identifying one side of the body as distinct from the other or identifying whether a part of the body is rotated to the left or right. We will assess both the accuracy and speed of discrimination. |
From Baseline to after treatment, with a 3-month and a 6- month follow up. |
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