Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Pain intensity: Numerical Rating Scale (Pain NRS) |
Pain intensity will be evaluated using an 11-point (0-10) Numerical Rating Scale (Pain NRS), which is a simple and easy-to-use measuring scale that consists of a sequence of numbers from zero to 10, in which zero represents "no pain" and 10 represents "the worst pain imaginable". The pain evaluation will be carried out verbally with the patient reporting the pain intensity. |
2 weeks after randomization |
|
Secondary |
Pain intensity: Numerical Rating Scale (Pain NRS) |
Pain intensity will be evaluated using an 11-point (0-10) Numerical Rating Scale (Pain NRS), which is a simple and easy-to-use measuring scale that consists of a sequence of numbers from zero to 10, in which zero represents "no pain" and 10 represents "the worst pain imaginable". The pain evaluation will be carried out verbally with the patient reporting the pain intensity. |
6 weeks after randomization |
|
Secondary |
Pain intensity at movement: Numerical Rating Scale (Pain NRS) |
Pain intensity will be evaluated during the cervical movements of flexion, extension, right and left lateral inclination and right and left rotation, using an 11-point (0-10) Numerical Rating Scale (Pain NRS) |
2 weeks after randomization |
|
Secondary |
Neck disability |
Neck disability will be evaluated using neck disability index (NDI) that consists of a 10-item questionnaire that assess the impact of pain on daily activities using a score from 0 to 5 for each section, with higher values indicating more severe impact. |
2 weeks after randomization |
|
Secondary |
Cervical range of motion |
Cervical range of motion will be measured with a fleximeter |
2 weeks after randomization |
|
Secondary |
Pressure Pain Threshold |
Pressure pain threshold (PPT) in the neck, shoulder girdle and anterior tibialis muscle will be measured using a Somedic Type II pressure algometer |
2 weeks after randomization |
|
Secondary |
Pain temporal summation (TS) |
Temporal summation (TS) will be induced by a pressure algometer. Ten (10) stimuli with a pressure of 40 kPa/s of the mean value of algometry performed prior on the upper trapezius. Patients will be asked about their pain using NRS at the first, fifth and tenth stimulus. |
2 weeks after randomization |
|
Secondary |
Conditioned pain modulation (CPM) |
The conditioned stimulus for eliciting CPM will be the cold pressor test (Cold Water Bath test to the hand) and the test stimulus will be the assessment of PPT on the upper trapezius muscle. |
2 weeks after randomization |
|
Secondary |
Depressive symptoms |
The depressive symptoms will be performed using Beck Depression Inventory (BDI). The scale consists of items including symptoms and attitudes whose intensity range from neutral to a maximum level of severity, rated from 0 to 3. |
2 weeks after randomization |
|
Secondary |
Pain catastrophizing |
Pain catastrophizing will be performed with Pain Catastrophizing Scale (PCS) - The PCS is a self-administered questionnaire that consists of 13 items to assess catastrophizers. The items are rated on a 5-point Likert-type scale in which both intensity and frequency information are represented, with the following ?ve levels of response for each Likert item: (0) not at all, (1) to a slight degree, (3) to a moderate degree, (4) to a great degree, (5) and all the time. The total score is computed by summation of all items and the total score ranges from 0 to 52 points. Higher scores indicate greater catastrophic pain. |
2 weeks after randomization |
|
Secondary |
Change in patient perception of quality of life:12-Item Short-Form Health Survey (SF-12) |
The quality of life will be performed using 12-Item Short-Form Health Survey (SF-12) version 2 questionnaire. This is a self-report measure that assesses physical (Physical Component Summary - PCS) and mental (Mental Component Summary - MCS) health on a scale of 0 - 100. Higher scores represent better levels of quality of life. |
2 weeks after randomization |
|
Secondary |
Analgesic intake |
Anlgesic intake will be evaluated asking to the patients all analgesic medications (opioids and non-opioids) taken one week prior to evaluation and during the treatment. |
2 weeks after randomization |
|
Secondary |
Global perceived effect (GPE) |
Global perceived effect will be evaluated by an 11 - point (- 5 to + 5) Global Perceived Effect Scale. It consists of an 11-point scale that ranges from -5 (vastly worse) through 0 (no change) to 5 (completely recovered). |
2 weeks and 6 weeks after randomization |
|