Functioning in Individuals With Cervical Radiculopathy After Posterior Cervical Decompression

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Radiculopathy
• Intervention / Treatment: Procedure: Posterior cervical foraminotomy (with our without laminectomy)

• Study Type: Observational
• Enrollment (Estimated): 154

Contacts and Locations

• Study Contact: Name: Jard Svensson, MSc; Phone Number: +46101034026; Email: jard.svensson@liu.se

Study Locations

• Sweden
  • Jönköping, Sweden
    • Recruiting
    • Neuro-ortopediska kliniken
    • Contact: Håkan Löfgren
  • Linköping, Sweden
    • Recruiting
    • Neurosurgery clinic
    • Contact: Jard Svensson
  • Stockholm, Sweden
    • Recruiting
    • Ryggkirurgiskt Centrum
    • Contact: Martin Skeppholm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck DisabiIity Index; 0-100% (0% = No disability)	To measure neck-specific disability	Change from baseline to 24 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Odom; 7-point scale (restored/much better to much worse)	To measure global perceived effect	Change from baseline to 24 months postoperatively
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
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
Pain Catastrophizing Scale; 0-52 (0 = no catastrophizing)	To measure catastrophizing	Change from baseline to 24 months postoperatively
Self-Efficacy Scale; 0-200 (0 = low Self-Efficacy)	To measure confidence in one's own ability	Change from baseline to 24 months postoperatively
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
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
Cherkin symptom satisfaction	To measure expectations met and satisfaction with care	Change from baseline to 24 months postoperatively
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Anneli Peolsson, PhD, Linköping University, Department of Health, Medicine and Caring Sciences, Unit of physiotherapy

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: CR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No