Outcomes After Surgery for Degenerative Cervical Radiculopathy in Patients with Concurrent Headache

March 21, 2025 updated by: Tore Solberg, University Hospital of North Norway

Patient Characteristics, Prognosis and Outcome Measures in Patients with Concurrent Neck Associated Headache Operated for Degenerative Cervical Radiculopathy. a Population Based Study by NORspine

Surgery for degenerative cervical radiculopathy (DCR) is one of the most common causes of neck surgery. The typical surgical indication is radicular pain (arm pain) caused by nerve impingement. However, many patients also report varying degrees of pain in the neck and head. This headache, often referred to as cervicogenic headache (CEH), is believed to result from the convergence of trigeminal afferents and the upper three cervical spinal nerves in structures such as facet joints, ligaments, cervical muscles, intervertebral and nerve roots.

The diagnostic criteria used to distinguish CEH from the other types of headaches are based on low to moderate evidence and can be challenging due to their similar clinical presentations. Nevertheless, headache disorders are a common cause of disability and many patients undergoing surgery for DCR report headache. However, prior reports assessing headache in patients surgically treated for DCR are limited by small sample sizes, inconsistent inclusion criteria and outcome measures. Consequently, there is limited understanding about the frequency of DCR associated headache and whether these patients experience meaningful improvements in their headache following surgical treatment.

The aims of this study are to assess 1) the frequency of DCR associated headache in patients operated for DCR, 2) the minimal clinical important change for NRS headache 3) if DCR associated headache is an independent prognostic factor for neck pain-related disability and 4) if patients experience improvement in their headache 12 months after surgery for DCR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypothesis:

Our null hypothesis is that DCR patients with and without concomitant headache have similar outcomes after surgery. Our alternative hypothesis is that concomitant headache is a negative predictor for a favourable outcome of DCR surgery, i.e. an effect size less than the MCIC value for improvement.

Data source:

The project will use prospectively collected data from the Norwegian Registry for Spine Surgery (NORspine). The NORspine is a comprehensive national clinical registry, with a capture rate of patients operated for DCR of 75% from 2021 and a response rate at 12 months follow-up of 80% in 2022. The coverage rate at the institutional level is 95-100%.

Analyses and reporting will be conducted according to the methodology proposed by PROGRESS (prognosis research strategy) framework, and reported according to the STROBE (strengthening the reporting of observational studies in epidemiology) statement.

Data collection:

Demographic variables, smoking, educational level, duration of symptoms, status on sick leave, working and disability status are collected at admission (baseline). Comorbidity, diagnosis, treatment as well as perioperative complications are recorded by surgeons. Patient reported outcome measures (PROMs) are recorded at admission (baseline) and 3- and 12 months follow-up time) after surgery.

Statistical analyses:

The invastigators will select patients with both headache and neck pain assessed with the NRS to assess the frequency of DCR associated headache.

To determine the MCIC of DCR associated headache the invastigators will use the global perceived effect (GPE) scale as the external criterion (anchor). The invastigators will assess the mean NRS headache score at 12 months, change score between baseline and 12 months follow-up and the corresponding percentage change score. A cut-off value for the NRS headache MCIC will be obtained by assessing values of sensitivity and specificity receiver operating curve (ROC).

Univariable and multivariable analyses will be used to evaluate if NRS headache is a potential prognostic factor against the NDI (35% improvement (yes/no) using binary logistic regression, adjusted for a priori selection of confounding factors. A p-value of <0.05 will be considered statistically significant.

Study Type

Observational

Enrollment (Actual)

12000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include consecutive patients operated for DCR in public and private hospitals and registered in the NORspine from January 2012 to December 2022.

Description

Inclusion criteria:

  • Patients 16 years or above and operated for degenerative cervical radiculopathy (disc herniation or spondylosis)
  • Single level or multiple (primary surgery)
  • Anterior cervical discectomy and fusion with or without plate
  • Artificial cervical disc replacement

Exclusion criteria:

  • Degenerative cervical myelopathy, tumour, inflammation, infection and trauma
  • Previous surgery in the cervical spine
  • Corpectomy
  • Posterior approach as laminectomi with or without fusion and foramenotomi

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck disability index (NDI)
Time Frame: 3- and 12 months
The NDI measures how neck pain affects daily life in the following domains: pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, using a 6-point ordinal scale (0-5). The 10 items are summarized and recalculated to a percentage score ranging from 0 to 100 (no to maximum disability). The NDI percentage change will be dichotomized to 35% improvement (yes/no).
3- and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NDI headache
Time Frame: 3- and 12 months
NDI headache scale contains the following responses: (0) "I have no headaches at all", (1) "I have slight headaches, which come infrequently", (2) "I have moderate headaches, which come infrequently", (3) "I have moderate headaches, which come frequently", (4) "I have severe headaches, which come frequently" and (5) "I have headaches almost all the time".
3- and 12 months
Numeric rating scale for neck pain (NRS-NP)
Time Frame: 3- and 12 months
NRS-NP assesses pain severity ranging from 0 to 10 ("no" to "worst conceivable pain").
3- and 12 months
Numeric rating scale for arm pain (NRS-AP)
Time Frame: 3- and 12 months
NRS-AP assesses pain severity ranging from 0 to 10 ("no" to "worst conceivable pain").
3- and 12 months
NRS-HA
Time Frame: 3- and 12 months
Numeric rating scale for headache (NRS-HA) assesses pain severity ranging from 0 to 10 ("no" to "worst conceivable pain").
3- and 12 months
Global perceived effect (GPE)
Time Frame: 3- and 12 months
GPE scale measures the perceived benefit after surgery: (1) "completely recovered," (2) "much improved," (3) "slightly improved," (4) "unchanged," (5) "slightly worse," (6) "much worse", and (7) "worse than ever."
3- and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D-3L
Time Frame: 12 month
EQ-5D-3L is a preference-weighted measure of health-related quality of life based on five dimensions: mobility, self-care, usual activity, pain/discomfort and anxiety/discomfort (23). The patient assesses three possible levels (3L); "none," "mild to moderate," and "severe" for each dimension. The score ranges from 0.59 to 1, where 1 corresponds to perfect health and 0 to death and negative values worse than death.
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Investigators

  • Principal Investigator: Tore Solberg, MD/PhD, University Hospital North Norway and The Arctic University of Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03276-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to patient sensitiv data content.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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