Functioning in Individuals With Cervical Radiculopathy After Posterior Cervical Decompression

Study Overview
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Brief Summary
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Compression on structures, as spinal nerves, in the cervical spine can cause cervical radiculopathy which leads to pain, disability, and reduced quality of life for the affected individual. Cervical foraminotomy with our without laminectomy are common posterior decompression surgical techniques for treating cervical radiculopathy. There is a lack of knowledge regarding function in patients with cervical radiculopathy after posterior cervical decompression. The aim with this study is to study pain, function, psychosocial factors, and health related quality of life after posterior cervical decompression in patients with cervical radiculopathy. This is a prospective multicenter longitudinal observational cohort study with follow-up at three, 12- and 24 months postoperative. A total of 154 individuals scheduled to undergo foraminotomy with our without laminectomy due to cervical radiculopathy will be included. Primary outcome is neck-specific function measured with the Neck Disability Index. Data will be collected preoperatively and at three, 12 and 24 months with electronic questionnaire.

Official Title
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Functioning in Individuals With Cervical Radiculopathy After Posterior Cervical Decompression: a Prospective Multicenter Observational Study With a 2 Year Follow-up.

Conditions
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Cervical Radiculopathy

Intervention / Treatment
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* Procedure: Posterior cervical foraminotomy (with our without laminectomy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cervical radiculopathy, confirmed by MRI images (or alternative neuroradiological imaging if MRI contraindicated) compatible with clinical findings of nerve root compression (neurological examination performed by a neurosurgeon/orthopedic surgeon) Posterior cervical decompression as foraminotomy with our without laminectomy At least 3 months of persistent arm pain Age 18-75 years Exclusion Criteria: Nurick score 2 or more (to exclude individuals with moderate to high myelopathy) Previous surgery of cervical spine Previous fracture or dislocation of the cervical spine Malignancy or benign spinal tumor (eg, neuromas) Spinal infection Previous spondylodiscitis Servere mental disorder Known alcohol or drug abuse Lack of ability to write/comprehend/express oneself in Swedish

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Posterior cervical foraminotomy (with our without laminectomy)|The aim of surgery is to decrease the compression of the affected nerve. In posterior cervical foraminotomy, the foramina is expanded to create more space and with posterior cervical laminectomy the lamina is removed to create space mainly for the spinal cord.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck DisabiIity Index; 0-100% (0% = No disability) | To measure neck-specific disability | Change from baseline to 24 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale; 0-10 (0 = No pain/dizziness) | To measure pain intensity in neck, arm and head; Dizziness and unsteadiness | Change from baseline to 24 months postoperatively | 
| Frequency of symptoms (5-grade scale from never to always) | To measure frequency of symptoms including neck pain, neck stiffness, headache, arm pain, impaired arm function, dizziness, sleeping problems, visual disturbances, hearing disturbances, difficulty swallowing and chewing, nausea, and problems concentrating. | Change from baseline to 24 months postoperatively | 
| Specific questions regarding headache and dizziness | To find out more about specific symptoms such as headaches and dizziness | Change from baseline to 24 months postoperatively | 
| Dizziness Handicap Inventory Scale; 0-100 (0 = no disability) | To measure self-perceived impact on daily life due to dizziness and/or unsteadiness | Change from baseline to 24 months postoperatively | 
| Short Form Headache Impact test; 36-78 (36 = no impact) | To measure impact of headache in daily life | Change from baseline to 24 months postoperatively | 
| Core outcome measure Index for neck; 0-10 (0 = good function) | To measure patient self-perceived outcome of spinal surgery | Change from baseline to 24 months postoperatively | 
| Patient derived Modified Japanese Orthopeadic Association; 0-18 (18 = normal/no myelopathy). | To measure the impact of myelopathy | Change from baseline to 24 months postoperatively | 
| Odom; 7-point scale (restored/much better to much worse) | To measure global perceived effect | Change from baseline to 24 months postoperatively | 
| Global rating of change scale; 11 points scale (-5 - 5 where 5 indicates restored). | To measure self-perceived effect | Change from baseline to 24 months postoperatively | 
| Fear Avoidance Beliefs Questionnaire; 0-96 (0 = no fear). | To measure patients' beliefs about how physical activity and work affect their neck pain | Change from baseline to 24 months postoperatively | 
| Pain Catastrophizing Scale; 0-52 (0 = no catastrophizing) | To measure catastrophizing | Change from baseline to 24 months postoperatively | 
| Self-Efficacy Scale; 0-200 (0 = low Self-Efficacy) | To measure confidence in one's own ability | Change from baseline to 24 months postoperatively | 
| Hospital Anxiety and Depression Scale; 0- 42 (0 = indicates no depression and anxiety) | To measure depression and anxiety | Change from baseline to 24 months postoperatively | 
| Question regarding expectations of surgery; 4 point scale (restored to no expectation to be restored) | To find out more about expectations of surgery | Change from baseline to 24 months postoperatively | 
| Cherkin symptom satisfaction | To measure expectations met and satisfaction with care | Change from baseline to 24 months postoperatively | 
| EuroQuol 5D-5L; 5-25 (5 = high health related quality of life) | To measure health-related quality of life | Change from baseline to 24 months postoperatively | 
| EQ thermometer; 0-100 (0 = low health related quality of life) | To measure health-related quality of life | Change from baseline to 24 months postoperatively | 
| Level of physical activity measured with a numeric rating; 1-4 (1 = inactivity - 4 high activity) | To find out more about level of physical activity | Change from baseline to 24 months postoperatively | 
| International Physical Activity Questionnaire short version (categorize to low, moderate and high activity level) | To measure level of physical activity | Change from baseline to 24 months postoperatively | 
| Work Ability Index (categorize to poor, moderate, good and excellent work ability) | To measure self-rated work ability | Change from baseline to 24 months postoperatively |