Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Background data such as age and gender, living circumstances |
Background data such as age, gender, living circumstances |
Baseline |
|
Primary |
Speckle tracking analyses of neck and shoulder muscle function |
Measured with medical ultrasonography during neck and arm exercises |
Baseline and at 3 months follow-up when intervention ended. The outcome measure is going to report a change over time for patients. |
|
Primary |
Cross-sectional area, volume, fatty infiltration and inflammation of neck muscles |
Neck and some whole body imaging measured with 3.0 T MRI scanner |
Baseline, 3 months. The outcome measure is going to report a change over time for patients. |
|
Primary |
Brain function in cortical networks related to pain |
Measured with a resting-state fMRI protocol with an echo planar imaging (EPI) sequence |
Baseline, 3 months. The outcome measure is going to report a change over time for patients. |
|
Primary |
Biomarkers for inflammation and stress |
Measured with blood samples and saliva |
Baseline, 3 months. The outcome measure is going to report a change over time for patients. |
|
Primary |
Cervikal kinaesthesia |
Neck-eye coordination |
Baseline, 3 months. The outcome measure is going to report a change over time for patients. |
|
Primary |
Balance test |
Postural sway during single and double leg stance |
Baseline, 3 months. The outcome measure is going to report a change over time for patients. |
|
Secondary |
Neck Disability Index (NDI) |
Self-reported neck-specific function. Score 0 to 50 (or in percentages 0% to 100%); 0p/0%=no disability, 50p/100%=complete activity limitation |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Whiplash Disability Questionnaire |
Disability associated with whiplash, in patients. Score 0 to 130; 0=no disability, 130=maximum disability. |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Patient-specific functional scale (PSFS) |
Individual ratings of function to quantify activity limitations, in patients. Score 0-10 score; 0= Unable to perform activity, 10= Able to perform activity at the same level as before injury or problem. Total score=sum of the activity scores/ number of activities. |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Pain intensity in neck, head, and arm and dizziness by a Visual Analogue Scale (VAS) (0-100 mm; where 0=no pain, 100= worst imaginable pain ) |
Pain intensity. Score 0 to 100 mm; 0=no pain, 100=worst imaginable pain |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Distribution of pain by a pain drawing assessed with images |
Distribution of pain, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Frequency of pain |
Frequency of pain, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Use of pain medications |
Use of pain medications, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Dizziness/balance by the Dizziness Handicap Inventory (DHI) |
Dizziness questionnaire, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Headache Questions by VAS and the Headache Impact Test (HIT-6) |
Impact of headache, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Pain Catastrophizing Scale (PCS), total scores range from 0 - 52; 0=no catastrophizing, 52= maximum catastrophizing |
Self-reported pain catastrophizing, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
EuroQuol five dimensions |
Self-reported health, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Effort Reward Imbalance questionnaire |
Work related balance between effort and reward, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Symptoms Satisfaction scale |
Satisfaction with present symptoms, in patients. 1 to 7 scale; 1=delighted, 7=terrible. |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Physical activity score, a combination score of the 2 questions (everyday physical activity and exercise/sport/open-air activity) to a combined 4-point score |
Physical activity. Score 0 to 4; 0=inactivity, 4=high activity. |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Health care consumption, number of visits |
Health care consumption, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Self-Efficacy Scale (SES) |
Self-reported self-efficacy, in patients. Score 0-200; 0=no self-efficacy, 200=strong self-efficacy |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Fear Avoidance Beliefs Questionnaire (FABQ) |
Fear Avoidance Beliefs, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Hospital Anxiety and Depression Scale (HAD) |
Depression and anxiety. Each subscale (depression and anxiety) range from 0 to 21; 0=normal, 21=severe |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Post Traumatic Stress Disorder checklist (PCL-S) |
Post Traumatic Stress, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Range of neck motion |
Range of motion, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Ergonomics questions and how work is perceived |
Work ergonomics, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Sickness presence by the Stanford presenteeism scale (SPS-6) |
Sickness presence at work, impact of health problems on individual work performance and overall perceived productivity , in patients. Scores 6-30, with lower scores indicting lower Presenteeism, and higher scores indicating higher Presenteeism. |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Patient Enablement Instrument (PEI) questionnaire |
Patient enablement, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Consumption of analgesic drugs prescribed through the drug registry |
Consumption of analgesic drugs, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Sick-leave registration, number of days and episodes |
Sick-leave, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Cognitive failures questionnaire (CFQ) |
Cognitive function, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Sensorimotor control of the neck muscles, mm Hg |
Sensorimotor control, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Neck muscle endurance of ventral and dorsal neck muscles in seconds |
Neck muscle endurance, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Balance measured in seconds, standing on one leg with eyes closed |
Balance, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Neurology |
Clinical examination of neurology, in patients, such as reflexes, sensibility, muscle weakness, Spurling´s test, neural tension test. |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Work Ability Index (WAI) |
Self-reported work ability, in patients |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|
Secondary |
Global rating of change scale |
Overall change because of the treatment, in patients. Score -5 (very much worse to +5 completely recovered and importance of change 0=not at all important, 100= very important. |
Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up |
|