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

Sponsor
Linkoeping University (Other)
Overall Status
Completed
CT.gov ID
NCT06113263
Collaborator
(none)
3,106
96

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Anterior cervical decompression surgery
  • Procedure: Posterior cervical foraminotomy with or without laminectomy

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
3106 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Anterior cervical decompression surgery

Individuals underwent anterior cervical decompression surgery due to cervical radiculopathy

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 decompression surgery

Individuals underwent posterior cervical decompression surgery due to cervical radiculopathy

Procedure: 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

Outcome Measures

Primary Outcome Measures

  1. Neck Disability Index [Preoperatively to 24 months follow-up]

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

Secondary Outcome Measures

  1. Headache measured with an item of Neck Disability Index [Preoperatively to 24 months follow-up]

    To measure headache; 0-5 (0 = no headache)

  2. Numeric rating scale [Preoperatively to 24 months follow-up]

    To measure neck and arm pain; 0-10 (0 = no pain)

  3. Bakground variables [Preoperatively]

    To measure gender, age, body mass index, educational level, smoker/non-smoker,

  4. Physically heavy work [Preoperatively]

    To measure how physically demanding the patient's work is; 0-3 (3 = heavy)

  5. Duration of neck pain [Preoperatively]

    To measure duration of neck pain; 0-4 (4 = more than 2 years)

  6. Duration of arm pain [Preoperatively]

    To measure duration of arm pain; 0-4 (4 = more than 2 years)

  7. Physiotherapy/rehabilitation [Preoperatively to 24 months follow-up]

    To measure the occurrence of physiotherapy/rehabilitation before and after surgery; Yes/No

  8. Specific questions about employment, pension and sickness benefits [Preoperatively to 24 months follow-up]

    To measure the patient's status about employment pension and sickness benefits

  9. Expectations of return to work [Preoperatively]

    To measure the expectations of return to work; 0-4 (4 = pension/sickness benefit)

  10. Consumption of pain-relieving drugs [Preoperatively to 24 months follow-up]

    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)

  11. Walking ability [Preoperatively to 24 months follow-up]

    To measure the walking ability; 1-4 (1 = less than 100 meters)

  12. Specific questions about self-reported complications [At 1-year follow-up]

    To measure self-reported complications

  13. EQ-5D-3L [Preoperatively to 24 months follow-up]

    To measure health-related quality of life; Index score (1 = best health state)

  14. EQ VAS [Preoperatively to 24 months follow-up]

    To measure patient's self-rated health; 0-100 (0 = worst imaginable health state)

  15. ASA Physical Status Classification System [Preoperatively]

    To measure patient's pre-anesthesia medical co-morbidities; 0-6 ( 0 = a normal healthy patient)

  16. Specific questions about operation data [Immediately after the operation]

    To study the operation and any complications reported by the surgeon.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • Patient-reported information about other diseases that severely limit the quality of life. The following options can be reported; Heart disease, neurological disease, cancer, other disease that affects the ability to walk and other disease that causes pain

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Linkoeping University

Investigators

  • Principal Investigator: Jard Svensson, MSc, Linköping University, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jard Svensson, MSc, Linkoeping University
ClinicalTrials.gov Identifier:
NCT06113263
Other Study ID Numbers:
  • Dekompression_swe
First Posted:
Nov 2, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2023