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

Completed

• Conditions: Cervical Radiculopathy

• 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

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
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)
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)
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)
Walking ability	Preoperatively	To measure the walking ability; ≤ 1 km or \> 1 km