Cervical RadiculopathyNCT06113263
Anterior and Posterior Decompression Surgery in Individuals with Cervical Radiculopathy and Headache
An observational study of Cervical Radiculopathy, run by Linkoeping University.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Anterior cervical decompression surgery and Posterior cervical foraminotomy with or without laminectomy
- Type of treatment
- Surgery or procedure
- How many people
- 2,889 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2021
- How long will I take part?
- 24 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cervical radiculopathy combined with headache underwent either anterior cervical decompression surgery or posterior cervical foraminotomy
Who may be able to join
- 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)
Who cannot join
- Myelopathy
- Previous neck surgery
About this study
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
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.
- Conditions
- Cervical Radiculopathy
- Being tested
- Anterior cervical decompression surgery, Posterior cervical foraminotomy with or without laminectomy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior cervical decompression surgeryProcedure or 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 laminectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Anterior cervical decompression surgery | Individuals underwent anterior cervical decompression surgery due to cervical radiculopathy Receives: Procedure: Anterior cervical decompression surgery | |
| Posterior cervical decompression surgery | Individuals underwent posterior cervical decompression surgery due to cervical radiculopathy Receives: Procedure: Posterior cervical foraminotomy with or without laminectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
To measure neck-specific disability; 0-100 % (0 % = no disability)
Measured: Preoperatively to 24 months follow-up
Secondary outcomes (11)
Headache measured with an item of Neck Disability Index
To measure headache; 0-5 (0 = no headache)
Measured: Preoperatively to 24 months follow-up
Numeric rating scale
To measure neck and arm pain; 0-10 (0 = no pain)
Measured: Preoperatively to 24 months follow-up
Bakground variables
To measure gender, age, body mass index, educational level, smoker/non-smoker,
Measured: Preoperatively
Duration of neck pain
To measure duration of neck pain; 0-4 (4 = more than 2 years) or 0-2 (2 = more than 2 years)
Measured: Preoperatively
Duration of arm pain
To measure duration of arm pain; 0-4 (4 = more than 2 years) or 0-2 (2 = more than 2 years)
Measured: Preoperatively
Work status
To measure the patient's work status; working (student), age retirement, sick leave, disability pension
Measured: Preoperatively
Consumption of pain-relieving drugs
To measure the consumption of pain-relieving drugs; 0-2 (0 = no consumption)
Measured: Preoperatively
Walking ability
To measure the walking ability; ≤ 1 km or > 1 km
Measured: Preoperatively
Specific questions about operation data
To study the operation and any complications reported by the surgeon.
Measured: Immediately after the operation
Self-reported other diseases that greatly limit the quality of life
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)
Measured: Preoperatively
EQ-5D-3L index
To measure health-related quality of life ; -0.594 - 1 (1 = best possible health status)
Measured: Preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jan 2014
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- 2,889 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jard Svensson, Linkoeping University
- Investigators
- Jard Svensson, MSc, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113263
- Sponsor's protocol ID
- Dekompression_swe
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06113263
- Acronym / sponsor ID
- Dekompression_swe
- Conditions
- Cervical Radiculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,889 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Nov 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior cervical decompression surgery | – | Procedure: Anterior cervical decompression surgeryIndividuals underwent anterior cervical decompression surgery due to cervical radiculopathy |
| Posterior cervical decompression surgery | – | Procedure: Posterior cervical foraminotomy with or without laminectomyIndividuals underwent posterior cervical decompression surgery due to cervical radiculopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cervical radiculopathy combined with headache underwent either anterior cervical decompression surgery or posterior cervical foraminotomy
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Myelopathy
- Previous neck surgery
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 decompression surgeryThe 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. | Procedure or surgery | Anterior cervical decompression surgery |
| Posterior cervical foraminotomy with or without laminectomyThe 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 | Procedure or surgery | Posterior cervical decompression surgery |
Primary outcome
Neck Disability Index
Time frame: Preoperatively to 24 months follow-up
To measure neck-specific disability; 0-100 % (0 % = no disability)
11 secondary outcomes
Headache measured with an item of Neck Disability Index
Time frame: Preoperatively to 24 months follow-up
Numeric rating scale
Time frame: Preoperatively to 24 months follow-up
Bakground variables
Time frame: Preoperatively
Duration of neck pain
Time frame: Preoperatively
Duration of arm pain
Time frame: Preoperatively
Work status
Time frame: Preoperatively
Consumption of pain-relieving drugs
Time frame: Preoperatively
Walking ability
Time frame: Preoperatively
Specific questions about operation data
Time frame: Immediately after the operation
Self-reported other diseases that greatly limit the quality of life
Time frame: Preoperatively
EQ-5D-3L index
Time frame: Preoperatively
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 25 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Jard Svensson, MSc principal investigator
Linkoeping University
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Radiculopathy, run by Linkoeping University.
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 3 inclusion and 2 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 25 Nov 2024. 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 (time frame: Preoperatively to 24 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2024.