Functioning in Individuals with Cervical Radiculopathy After Posterior Cervical Decompression
- Conditions
- Cervical Radiculopathy
- Registration Number
- NCT05310578
- Lead Sponsor
- Linkoeping University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 154
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Neck DisabiIity Index; 0-100% (0% = No disability) Change from baseline to 24 months postoperatively To measure neck-specific disability
- Secondary Outcome Measures
Name Time Method 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
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.
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
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
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
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
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
Cherkin symptom satisfaction Change from baseline to 24 months postoperatively To measure expectations met and satisfaction with care
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
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
Self-Efficacy Scale; 0-200 (0 = low Self-Efficacy) Change from baseline to 24 months postoperatively To measure confidence in one's own ability
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
Pain Catastrophizing Scale; 0-52 (0 = no catastrophizing) Change from baseline to 24 months postoperatively To measure catastrophizing
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
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
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
Trial Locations
- Locations (3)
Neurosurgery clinic
🇸🇪Linköping, Sweden
Neuro-ortopediska kliniken
🇸🇪Jönköping, Sweden
Ryggkirurgiskt Centrum
🇸🇪Stockholm, Sweden