HeadacheNCT06885216
Outcomes After Surgery for Degenerative Cervical Radiculopathy in Patients with Concurrent Headache
An observational study of Headache and Cervical Radiculopathy, run by University Hospital of North Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Headache, Cervical Radiculopathy
- What is being tested?
- Anterior cervical discectomy and fusion/ posterior decompression
- Type of treatment
- Surgery or procedure
- How many people
- 12,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Headache, Cervical Radiculopathy
- Being tested
- Anterior cervical discectomy and fusion/ posterior decompression
- Medical subject headings
- Headache, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior cervical discectomy and fusion/ posterior decompressionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck disability index (NDI)
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).
Measured: 3- and 12 months
Secondary outcomes (5)
NDI headache
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".
Measured: 3- and 12 months
Numeric rating scale for neck pain (NRS-NP)
NRS-NP assesses pain severity ranging from 0 to 10 ("no" to "worst conceivable pain").
Measured: 3- and 12 months
Numeric rating scale for arm pain (NRS-AP)
NRS-AP assesses pain severity ranging from 0 to 10 ("no" to "worst conceivable pain").
Measured: 3- and 12 months
NRS-HA
Numeric rating scale for headache (NRS-HA) assesses pain severity ranging from 0 to 10 ("no" to "worst conceivable pain").
Measured: 3- and 12 months
Global perceived effect (GPE)
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."
Measured: 3- and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Jan 2012
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tore Solberg, University Hospital of North Norway
- Investigators
- Tore Solberg, MD/PhD, Principal investigator, University Hospital North Norway and The Arctic University of Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885216
- Sponsor's protocol ID
- 03276-1
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient sensitiv data content.
Publications
Carette S, Fehlings MG. Clinical practice. Cervical radiculopathy. N Engl J Med. 2005 Jul 28;353(4):392-9. doi: 10.1056/NEJMcp043887. No abstract available.
PubMed 16049211Bogduk N. Cervicogenic headache: anatomic basis and pathophysiologic mechanisms. Curr Pain Headache Rep. 2001 Aug;5(4):382-6. doi: 10.1007/s11916-001-0029-7.
PubMed 11403743Demont A, Lafrance S, Benaissa L, Mawet J. Cervicogenic headache, an easy diagnosis? A systematic review and meta-analysis of diagnostic studies. Musculoskelet Sci Pract. 2022 Dec;62:102640. doi: 10.1016/j.msksp.2022.102640. Epub 2022 Aug 31.
PubMed 36088782GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
PubMed 30496104Torbjorn AF, Stolt-Nielsen A, Skaanes KO, Sjaastad O. Headache and the lower cervical spine: long-term, postoperative follow-up after decompressive neck surgery. Funct Neurol. 2003 Jan-Mar;18(1):17-28.
PubMed 12760410Liu H, Ploumis A, Wang S, Li C, Li H. Treatment of Cervicogenic Headache Concurrent With Cervical Stenosis by Anterior Cervical Decompression and Fusion. Clin Spine Surg. 2017 Oct;30(8):E1093-E1097. doi: 10.1097/BSD.0000000000000291.
PubMed 28937465Hemingway H, Riley RD, Altman DG. Ten steps towards improving prognosis research. BMJ. 2009 Dec 30;339:b4184. doi: 10.1136/bmj.b4184. No abstract available.
PubMed 20042483von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
PubMed 18064739Vernon H. The Neck Disability Index: state-of-the-art, 1991-2008. J Manipulative Physiol Ther. 2008 Sep;31(7):491-502. doi: 10.1016/j.jmpt.2008.08.006.
PubMed 18803999Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002.
PubMed 9366889Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
PubMed 16320034
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Characteristics, Prognosis and Outcome Measures in Patients with Concurrent Neck Associated Headache Operated for Degenerative Cervical Radiculopathy. a Population Based Study by NORspine
- ClinicalTrials.gov ID
- NCT06885216
- Acronym / sponsor ID
- 03276-1
- Conditions
- Headache, Cervical Radiculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior cervical discectomy and fusion/ posterior decompression | Procedure or surgery | – |
Primary outcome
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).
5 secondary outcomes
NDI headache
Time frame: 3- and 12 months
Numeric rating scale for neck pain (NRS-NP)
Time frame: 3- and 12 months
Numeric rating scale for arm pain (NRS-AP)
Time frame: 3- and 12 months
NRS-HA
Time frame: 3- and 12 months
Global perceived effect (GPE)
Time frame: 3- and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Background: PubMed 16049211Carette S, Fehlings MG. Clinical practice. Cervical radiculopathy. N Engl J Med. 2005 Jul 28;353(4):392-9. doi: 10.1056/NEJMcp043887. No abstract available.
- Background: PubMed 11403743Bogduk N. Cervicogenic headache: anatomic basis and pathophysiologic mechanisms. Curr Pain Headache Rep. 2001 Aug;5(4):382-6. doi: 10.1007/s11916-001-0029-7.
- Background: PubMed 36088782Demont A, Lafrance S, Benaissa L, Mawet J. Cervicogenic headache, an easy diagnosis? A systematic review and meta-analysis of diagnostic studies. Musculoskelet Sci Pract. 2022 Dec;62:102640. doi: 10.1016/j.msksp.2022.102640. Epub 2022 Aug 31.
- Background: PubMed 30496104GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
- Background: PubMed 12760410Torbjorn AF, Stolt-Nielsen A, Skaanes KO, Sjaastad O. Headache and the lower cervical spine: long-term, postoperative follow-up after decompressive neck surgery. Funct Neurol. 2003 Jan-Mar;18(1):17-28.
- Background: PubMed 28937465Liu H, Ploumis A, Wang S, Li C, Li H. Treatment of Cervicogenic Headache Concurrent With Cervical Stenosis by Anterior Cervical Decompression and Fusion. Clin Spine Surg. 2017 Oct;30(8):E1093-E1097. doi: 10.1097/BSD.0000000000000291.
- Background: PubMed 20042483Hemingway H, Riley RD, Altman DG. Ten steps towards improving prognosis research. BMJ. 2009 Dec 30;339:b4184. doi: 10.1136/bmj.b4184. No abstract available.
- Background: PubMed 18064739von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
- Background: PubMed 18803999Vernon H. The Neck Disability Index: state-of-the-art, 1991-2008. J Manipulative Physiol Ther. 2008 Sep;31(7):491-502. doi: 10.1016/j.jmpt.2008.08.006.
- Background: PubMed 9366889Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002.
- Background: PubMed 16320034Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
- Individual participant dataSharing planned: No. Due to patient sensitiv data content.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tore Solberg, MD/PhD principal investigator
University Hospital North Norway and The Arctic University of Norway
Questions about this trial
What is this clinical trial studying?
An observational study of Headache and Cervical Radiculopathy, run by University Hospital of North Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck disability index (NDI) (time frame: 3- and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06885216, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.