Cervical RadiculopathyNCT05310578
Functioning in Individuals With Cervical Radiculopathy After Posterior Cervical Decompression
An observational study of Cervical Radiculopathy, run by Linkoeping University at 3 sites in Sweden.
Trial summary
Compression on structures, as spinal nerves, in the cervical spine can cause cervical radiculopathy which leads to pain, disability, and reduced quality of life for the affected individual. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Posterior cervical foraminotomy (with our without laminectomy)
- Type of treatment
- Surgery or procedure
- How many people
- 154 participants
- Where
- 3 sitesSweden
- Study dates
- 22 Aug 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- Adult, Older adult
Study population: Individuals with cervical radiculopathy scheduled to undergo foraminotomy with our without laminectomy at one of three specific neurosurgery or neuroortopedic clinics in south of Sweden. Individuals are preoperative screened for eligibility and those who meet the criteria to participate in the study are asked for informed consent.
Who may be able to join
- Cervical radiculopathy, confirmed by MRI images (or alternative neuroradiological imaging if MRI contraindicated) compatible with clinical findings of nerve root compression (neurological examination performed by a neurosurgeon/orthopedic surgeon)
- Posterior cervical decompression as foraminotomy with our without laminectomy
- At least 3 months of persistent arm pain
- Age 18-75 years
Who cannot join
- Nurick score 2 or more (to exclude individuals with moderate to high myelopathy)
- Previous surgery of cervical spine
- Previous fracture or dislocation of the cervical spine
- Malignancy or benign spinal tumor (eg, neuromas)
- Spinal infection
- Previous spondylodiscitis
Show all 9Show fewer
- Servere mental disorder
- Known alcohol or drug abuse
- Lack of ability to write/comprehend/express oneself in Swedish
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Neuro-ortopediska kliniken
Jönköping
Håkan Löfgren
- Recruiting
Neurosurgery clinic
Linköping
Jard Svensson
- Recruiting
Ryggkirurgiskt Centrum
Stockholm
Martin Skeppholm
About this study
Official title: Functioning in Individuals With Cervical Radiculopathy After Posterior Cervical Decompression: a Prospective Multicenter Observational Study With a 2 Year Follow-up.
Compression on structures, as spinal nerves, in the cervical spine can cause cervical radiculopathy which leads to pain, disability, and reduced quality of life for the affected individual. Cervical foraminotomy with our without laminectomy are common posterior decompression surgical techniques for treating cervical radiculopathy. There is a lack of knowledge regarding function in patients with cervical radiculopathy after posterior cervical decompression.
The aim with this study is to study pain, function, psychosocial factors, and health related quality of life after posterior cervical decompression in patients with cervical radiculopathy.
This is a prospective multicenter longitudinal observational cohort study with follow-up at three, 12- and 24 months postoperative. A total of 154 individuals scheduled to undergo foraminotomy with our without laminectomy due to cervical radiculopathy will be included. Primary outcome is neck-specific function measured with the Neck Disability Index. Data will be collected preoperatively and at three, 12 and 24 months with electronic questionnaire.
- Conditions
- Cervical Radiculopathy
- Being tested
- Posterior cervical foraminotomy (with our 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.
Posterior cervical foraminotomy (with our without laminectomy)Procedure or surgery
The aim of surgery is to decrease the compression of the affected nerve. In posterior cervical foraminotomy, the foramina is expanded to create more space and with posterior cervical laminectomy the lamina is removed to create space mainly for the spinal cord.
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck DisabiIity Index; 0-100% (0% = No disability)
To measure neck-specific disability
Measured: Change from baseline to 24 months postoperatively
Secondary outcomes (20)
Numeric Rating Scale; 0-10 (0 = No pain/dizziness)
To measure pain intensity in neck, arm and head; Dizziness and unsteadiness
Measured: Change from baseline to 24 months postoperatively
Frequency of symptoms (5-grade scale from never to always)
To measure frequency of symptoms including neck pain, neck stiffness, headache, arm pain, impaired arm function, dizziness, sleeping problems, visual disturbances, hearing disturbances, difficulty swallowing and chewing, nausea, and problems concentrating.
Measured: Change from baseline to 24 months postoperatively
Specific questions regarding headache and dizziness
To find out more about specific symptoms such as headaches and dizziness
Measured: Change from baseline to 24 months postoperatively
Dizziness Handicap Inventory Scale; 0-100 (0 = no disability)
To measure self-perceived impact on daily life due to dizziness and/or unsteadiness
Measured: Change from baseline to 24 months postoperatively
Short Form Headache Impact test; 36-78 (36 = no impact)
To measure impact of headache in daily life
Measured: Change from baseline to 24 months postoperatively
Core outcome measure Index for neck; 0-10 (0 = good function)
To measure patient self-perceived outcome of spinal surgery
Measured: Change from baseline to 24 months postoperatively
Patient derived Modified Japanese Orthopeadic Association; 0-18 (18 = normal/no myelopathy).
To measure the impact of myelopathy
Measured: Change from baseline to 24 months postoperatively
Odom; 7-point scale (restored/much better to much worse)
To measure global perceived effect
Measured: Change from baseline to 24 months postoperatively
Global rating of change scale; 11 points scale (-5 - 5 where 5 indicates restored).
To measure self-perceived effect
Measured: Change from baseline to 24 months postoperatively
Fear Avoidance Beliefs Questionnaire; 0-96 (0 = no fear).
To measure patients' beliefs about how physical activity and work affect their neck pain
Measured: Change from baseline to 24 months postoperatively
Pain Catastrophizing Scale; 0-52 (0 = no catastrophizing)
To measure catastrophizing
Measured: Change from baseline to 24 months postoperatively
Self-Efficacy Scale; 0-200 (0 = low Self-Efficacy)
To measure confidence in one's own ability
Measured: Change from baseline to 24 months postoperatively
Hospital Anxiety and Depression Scale; 0- 42 (0 = indicates no depression and anxiety)
To measure depression and anxiety
Measured: Change from baseline to 24 months postoperatively
Question regarding expectations of surgery; 4 point scale (restored to no expectation to be restored)
To find out more about expectations of surgery
Measured: Change from baseline to 24 months postoperatively
Cherkin symptom satisfaction
To measure expectations met and satisfaction with care
Measured: Change from baseline to 24 months postoperatively
EuroQuol 5D-5L; 5-25 (5 = high health related quality of life)
To measure health-related quality of life
Measured: Change from baseline to 24 months postoperatively
EQ thermometer; 0-100 (0 = low health related quality of life)
To measure health-related quality of life
Measured: Change from baseline to 24 months postoperatively
Level of physical activity measured with a numeric rating; 1-4 (1 = inactivity - 4 high activity)
To find out more about level of physical activity
Measured: Change from baseline to 24 months postoperatively
International Physical Activity Questionnaire short version (categorize to low, moderate and high activity level)
To measure level of physical activity
Measured: Change from baseline to 24 months postoperatively
Work Ability Index (categorize to poor, moderate, good and excellent work ability)
To measure self-rated work ability
Measured: Change from baseline to 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start22 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jard Svensson, Linkoeping University
- Investigators
- Anneli Peolsson, PhD, Principal investigator, Linköping University, Department of Health, Medicine and Caring Sciences, Unit of physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310578
- Sponsor's protocol ID
- CR
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functioning in Individuals With Cervical Radiculopathy After Posterior Cervical Decompression: a Prospective Multicenter Observational Study With a 2 Year Follow-up.
- ClinicalTrials.gov ID
- NCT05310578
- Acronym / sponsor ID
- CR
- Conditions
- Cervical Radiculopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Apr 2022 (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.
Compression on structures, as spinal nerves, in the cervical spine can cause cervical radiculopathy which leads to pain, disability, and reduced quality of life for the affected individual. Cervical foraminotomy with our without laminectomy are common posterior decompression surgical techniques for treating cervical radiculopathy. There is a lack of knowledge regarding function in patients with cervical radiculopathy after posterior cervical decompression.
The aim with this study is to study pain, function, psychosocial factors, and health related quality of life after posterior cervical decompression in patients with cervical radiculopathy.
This is a prospective multicenter longitudinal observational cohort study with follow-up at three, 12- and 24 months postoperative. A total of 154 individuals scheduled to undergo foraminotomy with our without laminectomy due to cervical radiculopathy will be included. Primary outcome is neck-specific function measured with the Neck Disability Index. Data will be collected preoperatively and at three, 12 and 24 months with electronic questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals with cervical radiculopathy scheduled to undergo foraminotomy with our without laminectomy at one of three specific neurosurgery or neuroortopedic clinics in south of Sweden. Individuals are preoperative screened for eligibility and those who meet the criteria to participate in the study are asked for informed consent.
Key inclusion criteria (4 listed)
- Cervical radiculopathy, confirmed by MRI images (or alternative neuroradiological imaging if MRI contraindicated) compatible with clinical findings of nerve root compression (neurological examination performed by a neurosurgeon/orthopedic surgeon)
- Posterior cervical decompression as foraminotomy with our without laminectomy
- At least 3 months of persistent arm pain
- Age 18-75 years
Key exclusion criteria (9 listed)
- Nurick score 2 or more (to exclude individuals with moderate to high myelopathy)
- Previous surgery of cervical spine
- Previous fracture or dislocation of the cervical spine
- Malignancy or benign spinal tumor (eg, neuromas)
- Spinal infection
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 |
|---|---|---|
| Posterior cervical foraminotomy (with our without laminectomy)The aim of surgery is to decrease the compression of the affected nerve. In posterior cervical foraminotomy, the foramina is expanded to create more space and with posterior cervical laminectomy the lamina is removed to create space mainly for the spinal cord. | Procedure or surgery | – |
Primary outcome
Neck DisabiIity Index; 0-100% (0% = No disability)
Time frame: Change from baseline to 24 months postoperatively
To measure neck-specific disability
20 secondary outcomes
Numeric Rating Scale; 0-10 (0 = No pain/dizziness)
Time frame: Change from baseline to 24 months postoperatively
Frequency of symptoms (5-grade scale from never to always)
Time frame: Change from baseline to 24 months postoperatively
Specific questions regarding headache and dizziness
Time frame: Change from baseline to 24 months postoperatively
Dizziness Handicap Inventory Scale; 0-100 (0 = no disability)
Time frame: Change from baseline to 24 months postoperatively
Short Form Headache Impact test; 36-78 (36 = no impact)
Time frame: Change from baseline to 24 months postoperatively
Core outcome measure Index for neck; 0-10 (0 = good function)
Time frame: Change from baseline to 24 months postoperatively
Patient derived Modified Japanese Orthopeadic Association; 0-18 (18 = normal/no myelopathy).
Time frame: Change from baseline to 24 months postoperatively
Odom; 7-point scale (restored/much better to much worse)
Time frame: Change from baseline to 24 months postoperatively
Global rating of change scale; 11 points scale (-5 - 5 where 5 indicates restored).
Time frame: Change from baseline to 24 months postoperatively
Fear Avoidance Beliefs Questionnaire; 0-96 (0 = no fear).
Time frame: Change from baseline to 24 months postoperatively
Pain Catastrophizing Scale; 0-52 (0 = no catastrophizing)
Time frame: Change from baseline to 24 months postoperatively
Self-Efficacy Scale; 0-200 (0 = low Self-Efficacy)
Time frame: Change from baseline to 24 months postoperatively
Hospital Anxiety and Depression Scale; 0- 42 (0 = indicates no depression and anxiety)
Time frame: Change from baseline to 24 months postoperatively
Question regarding expectations of surgery; 4 point scale (restored to no expectation to be restored)
Time frame: Change from baseline to 24 months postoperatively
Cherkin symptom satisfaction
Time frame: Change from baseline to 24 months postoperatively
EuroQuol 5D-5L; 5-25 (5 = high health related quality of life)
Time frame: Change from baseline to 24 months postoperatively
EQ thermometer; 0-100 (0 = low health related quality of life)
Time frame: Change from baseline to 24 months postoperatively
Level of physical activity measured with a numeric rating; 1-4 (1 = inactivity - 4 high activity)
Time frame: Change from baseline to 24 months postoperatively
International Physical Activity Questionnaire short version (categorize to low, moderate and high activity level)
Time frame: Change from baseline to 24 months postoperatively
Work Ability Index (categorize to poor, moderate, good and excellent work ability)
Time frame: Change from baseline to 24 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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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.
Anneli Peolsson, PhD principal investigator
Linköping University, Department of Health, Medicine and Caring Sciences, Unit of physiotherapy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Radiculopathy, run by Linkoeping University at 3 sites in Sweden.
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 9 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jard Svensson, MSc (+46101034026, jard.svensson@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck DisabiIity Index; 0-100% (0% = No disability) (time frame: Change from baseline to 24 months postoperatively). 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 2 Sep 2026.