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

NCT06113263 | Completed

• 1 other identifier: Dekompression_swe
• Study Type: observational
• Target: 2,889
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index

  To measure neck-specific disability; 0-100 % (0 % = no disability)

  Preoperatively to 24 months follow-up

Secondary Outcomes (11)

• Headache measured with an item of Neck Disability Index

  Preoperatively to 24 months follow-up

• Numeric rating scale

  Preoperatively to 24 months follow-up

• Bakground variables

  Preoperatively

• Duration of neck pain

  Preoperatively

• Duration of arm pain

  Preoperatively

Study Arms (2)

Anterior cervical decompression surgery

Individuals underwent anterior cervical decompression surgery due to cervical radiculopathy

Procedure: Anterior cervical decompression surgery

Posterior cervical decompression surgery

Individuals underwent posterior cervical decompression surgery due to cervical radiculopathy

Procedure: Posterior cervical foraminotomy with or without laminectomy

Interventions

Anterior cervical decompression surgery PROCEDURE

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.

Anterior cervical decompression surgery

Posterior cervical foraminotomy with or without laminectomy PROCEDURE

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

Posterior cervical decompression surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Myelopathy
• Previous neck surgery

Sponsors & Collaborators

• Linkoeping University: lead

MeSH Terms

Conditions

Radiculopathy

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Jard Svensson, MSc

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: January 1, 2014
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 25, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share