Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Background data such as age and gender |
Background data such as age, gender, living circumstances and earlier care |
Baseline |
|
Primary |
Neck Disability Index (NDI) |
Self-reported neck-specific function |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Preoperative data from the Swespine register |
|
Secondary |
Pain intensities of the neck, arm, and head, measured using the Visual Analogue Scale (VAS 0-100 mm). |
Pain intensity VAS |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Pre-operative data from the Swespine register |
|
Secondary |
Pain intensities for the neck and arm will be assessed and registered using the Numeric Rating Scale (NRS) 0-10 scale in accordance with the Swespine registry |
Pain intensity NRS |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Distribution of pain by a Pain Drawing assessed with images |
painful areas are shaded on a human body image |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Use of pain medications |
Use of pain medications |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Modified Odom |
global outcomes of the intervention |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Dizziness/balance by the Dizziness Handicap Inventory (DHI) |
Self-reported dizziness |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Headache questions by VAS and the Headache Handicap Inventory (HIT-6) |
Impact of headache |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Disaster thoughts measured by the Pain Catastrophising Scale (PCS). |
Disaster thoughts |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Confidence in ability measured by the Self-Efficacy Scale (SES). |
Confidence in ability |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Patient Specific Functional Scale (PSFS). |
Estimation of neck-specific function related to participants' chosen activities (daily function, work, spare time |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Fear Avoidance Beliefs Questionnaire (FABQ). |
Operating fear |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Hospital Anxiety and Depression Scale (HAD). |
Self-reported anxiety and depression |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Health related quality of life measured by the EuroQuol five dimensions (EQ-5D) |
Health related quality of life |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Work Ability Index (WAI), short form |
Self-rated work ability |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Requirements - effort support in the workplace: Effort Reward Imbalance (ERI) |
effort and support in the workplace |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Ergonomics questions and how work is perceived |
Work ergonomics |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Sickness presence measured by the Stanford preseenteism scale |
Sickness presence at work |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Swedish Standard Classification of Occupations (SSY) code |
Classification of Occupations |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Patient Enablement Instrument (PEI) questionnaire |
Patient Enablement |
Follow-up at 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Satisfaction with symptoms measured by the Cherkin symptom satisfaction scale |
Satisfaction with symptoms |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Level of physical activity score, a combination of 2 questions (everyday physical activity and exercise/sport/open-air activity) to a combined 4-point score |
Physical activity |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Health-care consumption, number of visits |
Health-care consumption |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Consumption of analgesic drugs prescribed through the drug registry |
Consumption of analgesic drugs |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Frequency of pain |
Frequency of pain |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Sick-leave registration, number of days and episodes |
Sick-leave registration |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Neck movement measured using the cervical range of motion device (CROM) in degrees |
Active range of motion |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Endurance in the dorsal and ventral neck muscles, measured in seconds |
Neck muscle endurance |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Sensorimotor control of ventral neck muscles, in the supine position, with stabilizer (mm HG) |
Sensorimotor control |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Neurology, clinical judgement yes/no |
Neurology, such as reflexes, sensibility, muscle weakness and neural tension test. The results of the neurological examination gives an overall clinical judgement if segmental neurological findings is present and which cervical segmental level/ - is involved, |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Hand strength measured with a hand dynamometer (Jamar) |
Hand strength |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Standing on one leg with eyes closed (Solec test) |
Static balance |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
Conventional radiography, with side views taken during neutral positioning and dynamic flexion/extension |
Examination of implants, the degree of mobility of operated segments, subsidence and fusion |
Occurs routinely in the clinic for visits 3 months after surgery. Additional X-rays will be taken at the 2-year follow up to |
|
Secondary |
Register data for care use. To measure/monitor care use |
Care use |
Change from baseline to 3 months (the end of treatment) and 24 months follow-up |
|
Secondary |
MRI may be measured in a sub-group |
Neck muscle structure and maybe function |
Change from baseline to 3 months follow-up |
|
Secondary |
Ultrasound registrations may be measured in a sub-group, deformation and deformation rate |
Neck muscle function |
Change from baseline to 3 months follow-up |
|
Secondary |
Global rating of change scale |
Overall change because of the treatment |
Change from baseline to 3 and 24 months follow-ups, measured at follow-ups |
|