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

Completed

• Conditions: Cervical Radiculopathy
• Interventions: Procedure: Anterior cervical decompression surgery; Procedure: Posterior cervical foraminotomy with or without laminectomy

• Registration Number: NCT06113263
• Lead Sponsor: Linkoeping University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Status Verified: 2023-11
• Study First Posted: 2023-11-02
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2889

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anterior cervical decompression surgery	Anterior cervical decompression surgery	Individuals underwent anterior cervical decompression surgery due to cervical radiculopathy
Posterior cervical decompression surgery	Posterior cervical foraminotomy with or without laminectomy	Individuals underwent posterior cervical decompression surgery due to cervical radiculopathy

Primary Outcome Measures

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

Secondary Outcome Measures

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