Anterior and Posterior Decompression Surgery in Individuals with Cervical Radiculopathy and Headache

The Differences Between Anterior and Posterior Decompression Surgery in Individuals with Cervical Radiculopathy and Headache - a Registry Study with 2-year Follow-up

This is a prospective observational register-based cohort study with 2 years follow-up with data from the national Swedish Spine Register (Swespine). The aim is to study the differences between anterior and posterior decompression surgery on neck-related disability, headache, and neck- and arm pain in individuals with cervical radiculopathy and headache. Secondary, to study predictive factors for an improvement in neck-related disability, headache and neck- and arm pain after decompression srurgery. All individuals underwent either anterior or posterior decompression surgery and were operated between 2014-2021. Patient-reported data was collected preoperatively (baseline), and at 1- and 2-year follow-ups and surgeon-reported data regarding the operation were collected directly after the operation. Primary outcome is self-reported neck-related disability measured with Neck Disability Index and secondary outcomes are headache, measured with an item about headache of Neck Disability Index, and neck- and arm pain, measured with a 0 to 10-point numeric rating scale.

Study Overview

• Status: Completed
• Conditions: Cervical Radiculopathy
• Intervention / Treatment: Procedure: Anterior cervical decompression surgery; Procedure: Posterior cervical foraminotomy with or without laminectomy

• Study Type: Observational
• Enrollment (Actual): 2889

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with cervical radiculopathy combined with headache underwent either anterior cervical decompression surgery or posterior cervical foraminotomy

Description

Inclusion Criteria:

• Underwent anterior cervical decompression surgery or posterior cervical foraminotomy with or without laminectomy for cervical radiculopathy 2014 - 2021
• Age ≥ 18 years
• Preoperatively rated 1 (I have slight headaches, which come infrequently) - 5 (I have headaches almost all the time) on an item about headache of Neck Disability Index (27)

Exclusion Criteria:

• Myelopathy
• Previous neck surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anterior cervical decompression surgery; Individuals underwent anterior cervical decompression surgery due to cervical radiculopathy	Procedure: Anterior cervical decompression surgery; The aim of the surgery is to reduce the compression of the affected nerve. With anterior cervical decompression surgery this is achieved by removing the disc and osteophytes.
Posterior cervical decompression surgery; Individuals underwent posterior cervical decompression surgery due to cervical radiculopathy	Procedure: Posterior cervical foraminotomy with or without laminectomy; The aim of the surgery is to reduce the compression of the affected nerve. With posterior cervical decompression surgery more space is created for the nerve by widening the foramina where the nerve exits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index	To measure neck-specific disability; 0-100 % (0 % = no disability)	Preoperatively to 24 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache measured with an item of Neck Disability Index	To measure headache; 0-5 (0 = no headache)	Preoperatively to 24 months follow-up
Numeric rating scale	To measure neck and arm pain; 0-10 (0 = no pain)	Preoperatively to 24 months follow-up
Bakground variables	To measure gender, age, body mass index, educational level, smoker/non-smoker,	Preoperatively
Specific questions about operation data	To study the operation and any complications reported by the surgeon.	Immediately after the operation
Duration of neck pain	To measure duration of neck pain; 0-4 (4 = more than 2 years) or 0-2 (2 = more than 2 years)	Preoperatively
Duration of arm pain	To measure duration of arm pain; 0-4 (4 = more than 2 years) or 0-2 (2 = more than 2 years)	Preoperatively
Work status	To measure the patient's work status; working (student), age retirement, sick leave, disability pension	Preoperatively
Consumption of pain-relieving drugs	To measure the consumption of pain-relieving drugs; 0-2 (0 = no consumption)	Preoperatively
Walking ability	To measure the walking ability; ≤ 1 km or > 1 km	Preoperatively
Self-reported other diseases that greatly limit the quality of life	To measure self-reported other diseases that greatly limit the quality of life; Yes or No (heart disease, neurological disease, cancer, others disease that limitswalking ability, other disease that causes pain)	Preoperatively
EQ-5D-3L index	To measure health-related quality of life ; -0.594 - 1 (1 = best possible health status)	Preoperatively

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Jard Svensson, MSc, Linköping University, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy; Headache
• Other Study ID Numbers: Dekompression_swe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No