NCT Number: NCT05310578
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Neuro-ortopediska kliniken, Jönköping, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Change from baseline to 24 months postoperatively
To measure neck-specific disability
Time frame: Change from baseline to 24 months postoperatively
To measure pain intensity in neck, arm and head; Dizziness and unsteadiness
Time frame: 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.
Time frame: Change from baseline to 24 months postoperatively
To find out more about specific symptoms such as headaches and dizziness
Time frame: Change from baseline to 24 months postoperatively
To measure self-perceived impact on daily life due to dizziness and/or unsteadiness
Time frame: Change from baseline to 24 months postoperatively
To measure impact of headache in daily life
Time frame: Change from baseline to 24 months postoperatively
To measure patient self-perceived outcome of spinal surgery
Time frame: Change from baseline to 24 months postoperatively
To measure the impact of myelopathy
Time frame: Change from baseline to 24 months postoperatively
To measure global perceived effect
Time frame: Change from baseline to 24 months postoperatively
To measure self-perceived effect
Time frame: Change from baseline to 24 months postoperatively
To measure patients' beliefs about how physical activity and work affect their neck pain
Time frame: Change from baseline to 24 months postoperatively
To measure catastrophizing
Time frame: Change from baseline to 24 months postoperatively
To measure confidence in one's own ability
Time frame: Change from baseline to 24 months postoperatively
To measure depression and anxiety
Time frame: Change from baseline to 24 months postoperatively
To find out more about expectations of surgery
Time frame: Change from baseline to 24 months postoperatively
To measure expectations met and satisfaction with care
Time frame: Change from baseline to 24 months postoperatively
To measure health-related quality of life
Time frame: Change from baseline to 24 months postoperatively
To measure health-related quality of life
Time frame: Change from baseline to 24 months postoperatively
To find out more about level of physical activity
Time frame: Change from baseline to 24 months postoperatively
To measure level of physical activity
Time frame: Change from baseline to 24 months postoperatively
To measure self-rated work ability
Contact information is provided by the study sponsor or research team.
Linkoeping University
Other Gov
Functioning in Individuals with Cervical Radiculopathy After Posterior Cervical Decompression: a Prospective Multicenter Observational Study with a 2 Year Follow-up.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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