Functioning in Individuals With Cervical Radiculopathy After Posterior Cervical Decompression

Cervical Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05310578
• Other study ID #: CR
• Status: Recruiting
• Start date: August 22, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Linkoeping University
• Contact: Jard Svensson, MSc
• Phone: +46101034026
• Email: jard.svensson[@]liu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

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.

Locations

Country	Name	City	State
Sweden	Neuro-ortopediska kliniken	Jönköping
Sweden	Neurosurgery clinic	Linköping
Sweden	Ryggkirurgiskt Centrum	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck DisabiIity Index; 0-100% (0% = No disability)	To measure neck-specific disability	Change from baseline to 24 months postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Odom; 7-point scale (restored/much better to much worse)	To measure global perceived effect	Change from baseline to 24 months postoperatively
Secondary	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
Secondary	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
Secondary	Pain Catastrophizing Scale; 0-52 (0 = no catastrophizing)	To measure catastrophizing	Change from baseline to 24 months postoperatively
Secondary	Self-Efficacy Scale; 0-200 (0 = low Self-Efficacy)	To measure confidence in one's own ability	Change from baseline to 24 months postoperatively
Secondary	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
Secondary	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
Secondary	Cherkin symptom satisfaction	To measure expectations met and satisfaction with care	Change from baseline to 24 months postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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