About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Individuals with cervical radiculopathy scheduled to undergo foraminotomy with our without laminectomy at one of three specific neurosurgery or neuroortopedic clinics in south of Sweden. Individuals are preoperative screened for eligibility and those who meet the criteria to participate in the study are asked for informed consent.
Trial design
Cohort
Prospective
Treatments tested in this trial
Posterior cervical foraminotomy (with our without laminectomy)
Procedure/SurgeryThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Neck DisabiIity Index; 0-100% (0% = No disability)
To measure neck-specific disability
Secondary outcomes
Numeric Rating Scale; 0-10 (0 = No pain/dizziness)
To measure pain intensity in neck, arm and head; Dizziness and unsteadiness
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.
Specific questions regarding headache and dizziness
To find out more about specific symptoms such as headaches and dizziness
Dizziness Handicap Inventory Scale; 0-100 (0 = no disability)
To measure self-perceived impact on daily life due to dizziness and/or unsteadiness
Sponsors and contacts
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