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

Study Overview
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Brief Summary
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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.

Official Title
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The Differences Between Anterior and Posterior Decompression Surgery in Individuals With Cervical Radiculopathy and Headache - A Registry Study With 2-year Follow-up

Conditions
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Cervical Radiculopathy

Intervention / Treatment
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* Procedure: Anterior cervical decompression surgery
* Procedure: Posterior cervical foraminotomy with or without laminectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anterior cervical decompression surgery<br>Individuals underwent anterior cervical decompression surgery due to cervical radiculopathy | Procedure: Anterior cervical decompression surgery<br>* 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.<br>|
| Posterior cervical decompression surgery<br>Individuals underwent posterior cervical decompression surgery due to cervical radiculopathy | Procedure: Posterior cervical foraminotomy with or without laminectomy<br>* 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<br>|

What is the study measuring?
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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 | 
| Physically heavy work | To measure how physically demanding the patient's work is; 0-3 (3 = heavy) | Preoperatively | 
| Duration of neck pain | To measure duration of neck pain; 0-4 (4 = more than 2 years) | Preoperatively | 
| Duration of arm pain | To measure duration of arm pain; 0-4 (4 = more than 2 years) | Preoperatively | 
| Physiotherapy/rehabilitation | To measure the occurrence of physiotherapy/rehabilitation before and after surgery; Yes/No | Preoperatively to 24 months follow-up | 
| Specific questions about employment, pension and sickness benefits | To measure the patient's status about employment pension and sickness benefits | Preoperatively to 24 months follow-up | 
| Expectations of return to work | To measure the expectations of return to work; 0-4 (4 = pension/sickness benefit) | Preoperatively | 
| Consumption of pain-relieving drugs | To measure the consumption of pain-relieving drugs; 0-2 (0 = no consumption) To measure type of pain-relieving drugs; morphine-like preparations or specifically for nerve pain (yes/no) | Preoperatively to 24 months follow-up | 
| Walking ability | To measure the walking ability; 1-4 (1 = less than 100 meters) | Preoperatively to 24 months follow-up | 
| Specific questions about self-reported complications | To measure self-reported complications | At 1-year follow-up | 
| EQ-5D-3L | To measure health-related quality of life; Index score (1 = best health state) | Preoperatively to 24 months follow-up | 
| EQ VAS | To measure patient's self-rated health; 0-100 (0 = worst imaginable health state) | Preoperatively to 24 months follow-up | 
| ASA Physical Status Classification System | To measure patient's pre-anesthesia medical co-morbidities; 0-6 ( 0 = a normal healthy patient) | Preoperatively | 
| Specific questions about operation data | To study the operation and any complications reported by the surgeon. | Immediately after the operation |