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

Cervical Radiculopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06113263
• Other study ID #: Dekompression_swe
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2023
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3106
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Headache
• Radiculopathy

Intervention

Procedure:
• Anterior cervical decompression surgery
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.
• Posterior cervical foraminotomy with or without laminectomy
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index	To measure neck-specific disability; 0-100 % (0 % = no disability)	Preoperatively to 24 months follow-up
Secondary	Headache measured with an item of Neck Disability Index	To measure headache; 0-5 (0 = no headache)	Preoperatively to 24 months follow-up
Secondary	Numeric rating scale	To measure neck and arm pain; 0-10 (0 = no pain)	Preoperatively to 24 months follow-up
Secondary	Bakground variables	To measure gender, age, body mass index, educational level, smoker/non-smoker,	Preoperatively
Secondary	Physically heavy work	To measure how physically demanding the patient's work is; 0-3 (3 = heavy)	Preoperatively
Secondary	Duration of neck pain	To measure duration of neck pain; 0-4 (4 = more than 2 years)	Preoperatively
Secondary	Duration of arm pain	To measure duration of arm pain; 0-4 (4 = more than 2 years)	Preoperatively
Secondary	Physiotherapy/rehabilitation	To measure the occurrence of physiotherapy/rehabilitation before and after surgery; Yes/No	Preoperatively to 24 months follow-up
Secondary	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
Secondary	Expectations of return to work	To measure the expectations of return to work; 0-4 (4 = pension/sickness benefit)	Preoperatively
Secondary	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
Secondary	Walking ability	To measure the walking ability; 1-4 (1 = less than 100 meters)	Preoperatively to 24 months follow-up
Secondary	Specific questions about self-reported complications	To measure self-reported complications	At 1-year follow-up
Secondary	EQ-5D-3L	To measure health-related quality of life; Index score (1 = best health state)	Preoperatively to 24 months follow-up
Secondary	EQ VAS	To measure patient's self-rated health; 0-100 (0 = worst imaginable health state)	Preoperatively to 24 months follow-up
Secondary	ASA Physical Status Classification System	To measure patient's pre-anesthesia medical co-morbidities; 0-6 ( 0 = a normal healthy patient)	Preoperatively
Secondary	Specific questions about operation data	To study the operation and any complications reported by the surgeon.	Immediately after the operation