Functioning in Individuals With Cervical Radiculopathy After Posterior Cervical Decompression
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Neck DisabiIity Index; 0-100% (0% = No disability) [Change from baseline to 24 months postoperatively]
To measure neck-specific disability
Secondary Outcome Measures
- Numeric Rating Scale; 0-10 (0 = No pain/dizziness) [Change from baseline to 24 months postoperatively]
To measure pain intensity in neck, arm and head; Dizziness and unsteadiness
- Frequency of symptoms (5-grade scale from never to always) [Change from baseline to 24 months postoperatively]
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.
- Specific questions regarding headache and dizziness [Change from baseline to 24 months postoperatively]
To find out more about specific symptoms such as headaches and dizziness
- Dizziness Handicap Inventory Scale; 0-100 (0 = no disability) [Change from baseline to 24 months postoperatively]
To measure self-perceived impact on daily life due to dizziness and/or unsteadiness
- Short Form Headache Impact test; 36-78 (36 = no impact) [Change from baseline to 24 months postoperatively]
To measure impact of headache in daily life
- Core outcome measure Index for neck; 0-10 (0 = good function) [Change from baseline to 24 months postoperatively]
To measure patient self-perceived outcome of spinal surgery
- Patient derived Modified Japanese Orthopeadic Association; 0-18 (18 = normal/no myelopathy). [Change from baseline to 24 months postoperatively]
To measure the impact of myelopathy
- Odom; 7-point scale (restored/much better to much worse) [Change from baseline to 24 months postoperatively]
To measure global perceived effect
- Global rating of change scale; 11 points scale (-5 - 5 where 5 indicates restored). [Change from baseline to 24 months postoperatively]
To measure self-perceived effect
- Fear Avoidance Beliefs Questionnaire; 0-96 (0 = no fear). [Change from baseline to 24 months postoperatively]
To measure patients' beliefs about how physical activity and work affect their neck pain
- Pain Catastrophizing Scale; 0-52 (0 = no catastrophizing) [Change from baseline to 24 months postoperatively]
To measure catastrophizing
- Self-Efficacy Scale; 0-200 (0 = low Self-Efficacy) [Change from baseline to 24 months postoperatively]
To measure confidence in one's own ability
- Hospital Anxiety and Depression Scale; 0- 42 (0 = indicates no depression and anxiety) [Change from baseline to 24 months postoperatively]
To measure depression and anxiety
- Question regarding expectations of surgery; 4 point scale (restored to no expectation to be restored) [Change from baseline to 24 months postoperatively]
To find out more about expectations of surgery
- Cherkin symptom satisfaction [Change from baseline to 24 months postoperatively]
To measure expectations met and satisfaction with care
- EuroQuol 5D-5L; 5-25 (5 = high health related quality of life) [Change from baseline to 24 months postoperatively]
To measure health-related quality of life
- EQ thermometer; 0-100 (0 = low health related quality of life) [Change from baseline to 24 months postoperatively]
To measure health-related quality of life
- Level of physical activity measured with a numeric rating; 1-4 (1 = inactivity - 4 high activity) [Change from baseline to 24 months postoperatively]
To find out more about level of physical activity
- International Physical Activity Questionnaire short version (categorize to low, moderate and high activity level) [Change from baseline to 24 months postoperatively]
To measure level of physical activity
- Work Ability Index (categorize to poor, moderate, good and excellent work ability) [Change from baseline to 24 months postoperatively]
To measure self-rated work ability
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
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Posterior cervical decompression as foraminotomy with our without laminectomy
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At least 3 months of persistent arm pain
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Age 18-75 years
Exclusion Criteria:
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Nurick score 2 or more (to exclude individuals with moderate to high myelopathy)
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Previous surgery of cervical spine
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Previous fracture or dislocation of the cervical spine
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Malignancy or benign spinal tumor (eg, neuromas)
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Spinal infection
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Previous spondylodiscitis
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Servere mental disorder
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Known alcohol or drug abuse
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Lack of ability to write/comprehend/express oneself in Swedish
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Linkoeping University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR