Clinical trial NCT06113263: Anterior and Posterior Decompression Surgery in Individuals with Cervical Radiculopathy and Headache
Official title: The Differences Between Anterior and Posterior Decompression Surgery in Individuals with Cervical Radiculopathy and Headache - a Registry Study with 2-year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Radiculopathy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2023-11-02
Enrollment: 2889
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cervical radiculopathy combined with headache underwent either anterior cervical decompression surgery or posterior cervical foraminotomy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Neck Disability Index
timeFrame: Preoperatively to 24 months follow-up
Secondary outcomes:
measure: Headache measured with an item of Neck Disability Index
timeFrame: Preoperatively to 24 months follow-up
measure: Numeric rating scale
timeFrame: Preoperatively to 24 months follow-up
measure: Bakground variables
timeFrame: Preoperatively
measure: Duration of neck pain
timeFrame: Preoperatively
measure: Duration of arm pain
timeFrame: Preoperatively
measure: Work status
timeFrame: Preoperatively
measure: Consumption of pain-relieving drugs
timeFrame: Preoperatively
measure: Walking ability
timeFrame: Preoperatively
measure: Specific questions about operation data
timeFrame: Immediately after the operation
measure: Self-reported other diseases that greatly limit the quality of life
timeFrame: Preoperatively
measure: EQ-5D-3L index
timeFrame: Preoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Linkoeping University
name: Jard Svensson, MSc
role: PRINCIPAL_INVESTIGATOR
References: