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NCT Number: NCT06113263

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

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.

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Key information

Conditions

Cervical Radiculopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Neck Disability Index

    Time frame: Preoperatively to 24 months follow-up

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

Secondary outcomes

  1. Headache measured with an item of Neck Disability Index

    Time frame: Preoperatively to 24 months follow-up

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

  2. Numeric rating scale

    Time frame: Preoperatively to 24 months follow-up

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

  3. Bakground variables

    Time frame: Preoperatively

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

  4. Duration of neck pain

    Time frame: Preoperatively

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

  5. Duration of arm pain

    Time frame: Preoperatively

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

  6. Work status

    Time frame: Preoperatively

    To measure the patient's work status; working (student), age retirement, sick leave, disability pension

  7. Consumption of pain-relieving drugs

    Time frame: Preoperatively

    To measure the consumption of pain-relieving drugs; 0-2 (0 = no consumption)

  8. Walking ability

    Time frame: Preoperatively

    To measure the walking ability; ≤ 1 km or > 1 km

  9. Specific questions about operation data

    Time frame: Immediately after the operation

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

  10. Self-reported other diseases that greatly limit the quality of life

    Time frame: Preoperatively

    To measure self-reported other diseases that greatly limit the quality of life; Yes or No (heart disease, neurological disease, cancer, others disease that limitswalking ability, other disease that causes pain)

  11. EQ-5D-3L index

    Time frame: Preoperatively

    To measure health-related quality of life ; -0.594 - 1 (1 = best possible health status)

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

The Differences Between Anterior and Posterior Decompression Surgery in Individuals with Cervical Radiculopathy and Headache - a Registry Study with 2-year Follow-up

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2023
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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