Cervical RadiculopathyCRTNCT03674619

Cervical Radiculopathy Trial

A study testing Anterior discectomy and Conservative treatment in people with Cervical Radiculopathy, run by Oslo University Hospital at 1 site in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Cervical Radiculopathy
What is being tested?: Anterior discectomy and Conservative treatment
Type of treatment: Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteNorway
Study dates: 19 Oct 2018to 31 Jan 2028
Phase: Interventional
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 20 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 20 to 65 years.
Study 1: Neck and arm pain for at least 3 months with a corresponding herniation involving one cervical nerve root (C6 or C7) Study 2: Neck and arm pain for at least 3 months with a corresponding spondylosis involving C6 and/or C7) .
Pain intensity of arm pain of at least 4 on a scale from 0 (no pain) to 10 (worst possible pain)
Willing to accept either of the treatment alternatives
NDI > 30

Who cannot join

Patients with any previous cervical fractures or cervical spine surgery;
Signs of myelopathy;
Rapidly progressive paresis or paresis < grade 4;
Pregnancy;
Arthritis involving the cervical spine;
Infection or active cancer;

Show all 12Show fewer

Generalised pain syndrome;
Serious psychiatric or somatic disease that exclude one of the treatment alternatives;
Concomitant shoulder disorders that may interfere with outcome;
Abuse of medication/narcotics,
Not able to understand written Norwegian,
Not willing to accept one of the treatment alternatives.

Trial locations and contacts

1 site in 1 country.

Norway1 site

Oslo University Hospital
Oslo, 0424

Other trials in Norway

About this study

Official title: A Randomised Controlled Trial Comparing the Effectiveness of Surgical and Nonsurgical Treatment for Cervical Radiculopathy

The primary aim of the present project is to compare the effectiveness of surgery and nonsurgical treatment in patients with cervical radiculopathy caused by either disc herniation or spondylosis. Secondary aims are to evaluate cost-effectiveness and predicting factors of success of the two treatments, and to explore the terms success rate and expectations by asking the patients to fill in their expected primary outcome score at baseline.

Read the detailed description

Cervical radiculopathy is usually caused by disc herniation or spondylosis. Prognosis is expected to be good in most patients but there is limited scientific evidence about the indication for non-surgical and surgical treatment.

Two randomised controlled trials comparing cervical decompression and non-operative treatment with cost-effectiveness analysis and assessment of expectations and predictors of outcome. The main research question will be evaluated at one-year follow-up.

To test the hypothesis that the effectiveness of surgery as measured by the change in Neck Disability Index (NDI) at 1-year follow-up in patients with cervical radiculopathy is not different from non-surgical treatment in:
Study 1: one level disc herniation (C5/6 or C6/7)
Study 2: one or two level spondylosis (C5/6 and/or C6/7)
To test the hypothesis that surgery is more effective in patients with more clinical finding (dermatomal sensory loss, myotonal weakness and reflex disturbance) at baseline when adjusted for other possible predictors such as age, gender, baseline pain, duration, radiological findings, expectations, and psychological factors).
To estimate cost-effectiveness for health care costs and societal costs (including sickness absence) in surgical versus non-surgical patients.
To assess radiological (MRI and CT) measurements of foraminal area and nerve compression and if changes can predict clinical changes (NDI and arm pain) at 1-year .
To evaluate treatment outcome expectations at baseline asking the patients to fill in their expected improvement.

Conditions: Cervical Radiculopathy
Being tested: Anterior discectomy, Conservative treatment
Medical subject headings: Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anterior discectomyProcedure or surgery
Anterior discectomy will be performed and a microscope is used. After separation of the platysma muscle the pre-vertebral space is reached by an approach medial to the sternocleido-mastoid muscle and the carotid artery and lateral to the trachea and oesophagus. Then the disc is incided and the corpora are distracted to perform discectomy. Usually the posterior ligament is cut and the spinal root is decompressed and if necessary the arthritic rims are removed. An inter-vertebral fusion device is inserted, two levels are allowed in the spondylosis study.
Conservative treatmentBehavioural
Patients will first attend an experienced specialist in physical medicine and rehabilitation who will answer concerns and questions and if necessary repeat the information given before inclusion. The aim of the brief intervention is to promote better understanding and coping of the condition. The intervention will include supervision by a physiotherapist (6 sessions altogether) and provide advice on how to handle secondary neck muscle pain and dysfunction, reduce eventual fear avoidance, and advice to stay active.

Study groups in NCT03674619
Study group	Role	What they receive
Surgical treatment	Active comparator	Anterior discectomy Receives: Procedure: Anterior discectomy
Conservative treatment	Active comparator	Patients will attend an experienced specialist in physical medicine and rehabilitation and a physiotherapist. Receives: Behavioral: Conservative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Neck Disability Index
Consists of ten questions about pain related disability and include items such as by example headache, concentration, reading and sleep. Each item is rated by choosing one of five response categories and transformed to a total score from 0 to 100 (worst possible). The Norwegian version has been validated in patients with neck pain and with cervical radiculopathy.
Measured: Follow-up at 52 weeks is the primary end point.

Secondary outcomes (11)

Neck pain
Neck pain measured by Numeric Rating Scale (NRS) from 0 (no pain to 10 (worst imaginable pain).
Measured: 52 weeks
EuroQol (EQ-5D-5L and EQ-VAS)
EQ-5D-5L includes five domains: mobility; self-care, daily activities, pain/discomfort, and anxiety/depression and each has three response categories. The responses are transformed into and index to value the patients' health related quality of life for the cost utility analyses. Patients score their health from 0 (as bad as possible) to 100 (best possible) by EQ-VAS. The Norwegian version has been validated in patients with back pain, idiopathic scoliosis, and cervical radiculopathy.
Measured: 52 weeks
Fear-avoidance beliefs
Evaluated with the Fear Avoidance Beliefs Questionnaire
Measured: 52 weeks
Emotional distress
Assessed by the 10-question version of the Hopkins Symptom Check List
Measured: 52 weeks
Perceived recovery
Perceived recovery or change of the main symptom rated on a numeric scale ranging from -9 (worst possible change) to 9 (best possible change)
Measured: 52 weeks
Sickness absence data
Sickness absence data will be collected from the National Social Security Institution for the year before and after inclusion.
Measured: 52 weeks
Dysphagia
As recorded by The Dysphagia Short Questionnaire
Measured: 52 weeks
Medicine consumption
Questions related to pain medication usage.
Measured: 52 weeks
Patient expectations
Exploring patient expectations ahead of treatment. The patients are asked to fill out the Neck Disability Index pretending they are at 52 weeks post treatment and selecting the lowest category they would be content with for each item. The patients are also asked to report what they expect their symptoms to be like 52 weeks ahead (ranging from much worse to much better), registered for arm pain, neck pain and headache separately.
Measured: At inclusion
Success rate
Exploring global success rate by asking the patients about how the arm pain and neck pain is compared to prior to treatment (ranging from much worse to much better).
Measured: 52 weeks
Arm pain
Arm pain measured by Numeric Rating Scale (NRS) from 0 (no pain to 10 (worst imaginable pain).
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 201831 Jan 2028

First posted17 Sep 2018
Study start19 Oct 2018
Primary completion31 Jan 2028 (estimated)
Study completion31 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
More trials run by Oslo University HospitalThe 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03674619
Sponsor's protocol ID: 2017/2125
Acronym: CRT
Status last verified: Dec 2024
First submitted: 14 Sep 2018
Last updated: 19 Dec 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Taso M, Sommernes JH, Sundseth J, Pripp AH, Bjorland S, Engebretsen KB, Kolstad F, Zwart JA, Brox JI. Surgical versus Nonsurgical Treatment for Cervical Radiculopathy. NEJM Evid. 2025 Apr;4(4):EVIDoa2400404. doi: 10.1056/EVIDoa2400404. Epub 2025 Mar 25.
PubMed 40130970
Taso M, Sommernes JH, Bjorland S, Zwart JA, Engebretsen KB, Sundseth J, Pripp AH, Kolstad F, Brox JI. What is success of treatment? Expected outcome scores in cervical radiculopathy patients were much higher than the previously reported cut-off values for success. Eur Spine J. 2022 Oct;31(10):2761-2768. doi: 10.1007/s00586-022-07234-7. Epub 2022 May 13.
PubMed 35551484
Taso M, Sommernes JH, Kolstad F, Sundseth J, Bjorland S, Pripp AH, Zwart JA, Brox JI. A randomised controlled trial comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy. BMC Musculoskelet Disord. 2020 Mar 16;21(1):171. doi: 10.1186/s12891-020-3188-6.
PubMed 32178655

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
RecruitingObservational study
Gelified Radiopaque Ethanol (Absolute Gel) in Cervical Disc Herniation: an Observational Study in Routine Clinical Practice (GENESIS)
Cervical Disc Herniation, Intervertebral Disc Displacement

All Cervical Radiculopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Controlled Trial Comparing the Effectiveness of Surgical and Nonsurgical Treatment for Cervical Radiculopathy
ClinicalTrials.gov ID: NCT03674619
Acronym / sponsor ID: CRT / 2017/2125
Conditions: Cervical Radiculopathy
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 180 participants (actual)
Lead sponsor: Oslo University HospitalUniversity, hospital or other
Study start: 19 Oct 2018 (actual)
Primary completion: 31 Jan 2028 (estimated)
Study completion: 31 Jan 2028 (estimated)
First posted: 17 Sep 2018 (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.

Detailed description

To test the hypothesis that the effectiveness of surgery as measured by the change in Neck Disability Index (NDI) at 1-year follow-up in patients with cervical radiculopathy is not different from non-surgical treatment in:
Study 1: one level disc herniation (C5/6 or C6/7)
Study 2: one or two level spondylosis (C5/6 and/or C6/7)
To test the hypothesis that surgery is more effective in patients with more clinical finding (dermatomal sensory loss, myotonal weakness and reflex disturbance) at baseline when adjusted for other possible predictors such as age, gender, baseline pain, duration, radiological findings, expectations, and psychological factors).
To estimate cost-effectiveness for health care costs and societal costs (including sickness absence) in surgical versus non-surgical patients.
To assess radiological (MRI and CT) measurements of foraminal area and nerve compression and if changes can predict clinical changes (NDI and arm pain) at 1-year .
To evaluate treatment outcome expectations at baseline asking the patients to fill in their expected improvement.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Surgical treatment	Active comparator	Procedure: Anterior discectomyAnterior discectomy
Conservative treatment	Active comparator	Behavioral: Conservative treatmentPatients will attend an experienced specialist in physical medicine and rehabilitation and a physiotherapist.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 20 to 65 years.
Study 1: Neck and arm pain for at least 3 months with a corresponding herniation involving one cervical nerve root (C6 or C7) Study 2: Neck and arm pain for at least 3 months with a corresponding spondylosis involving C6 and/or C7) .
Pain intensity of arm pain of at least 4 on a scale from 0 (no pain) to 10 (worst possible pain)
Willing to accept either of the treatment alternatives
NDI > 30

Key exclusion criteria (12 listed)

Patients with any previous cervical fractures or cervical spine surgery;
Signs of myelopathy;
Rapidly progressive paresis or paresis < grade 4;
Pregnancy;
Arthritis involving the cervical spine;

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 discectomyAnterior discectomy will be performed and a microscope is used. After separation of the platysma muscle the pre-vertebral space is reached by an approach medial to the sternocleido-mastoid muscle and the carotid artery and lateral to the trachea and oesophagus. Then the disc is incided and the corpora are distracted to perform discectomy. Usually the posterior ligament is cut and the spinal root is decompressed and if necessary the arthritic rims are removed. An inter-vertebral fusion device is inserted, two levels are allowed in the spondylosis study.	Procedure or surgery	Surgical treatment
Conservative treatmentPatients will first attend an experienced specialist in physical medicine and rehabilitation who will answer concerns and questions and if necessary repeat the information given before inclusion. The aim of the brief intervention is to promote better understanding and coping of the condition. The intervention will include supervision by a physiotherapist (6 sessions altogether) and provide advice on how to handle secondary neck muscle pain and dysfunction, reduce eventual fear avoidance, and advice to stay active.	Behavioural	Conservative treatment

Primary outcome

Neck Disability Index
Time frame: Follow-up at 52 weeks is the primary end point.
Consists of ten questions about pain related disability and include items such as by example headache, concentration, reading and sleep. Each item is rated by choosing one of five response categories and transformed to a total score from 0 to 100 (worst possible). The Norwegian version has been validated in patients with neck pain and with cervical radiculopathy.

11 secondary outcomes

Neck pain
Time frame: 52 weeks
EuroQol (EQ-5D-5L and EQ-VAS)
Time frame: 52 weeks
Fear-avoidance beliefs
Time frame: 52 weeks
Emotional distress
Time frame: 52 weeks
Perceived recovery
Time frame: 52 weeks
Sickness absence data
Time frame: 52 weeks
Dysphagia
Time frame: 52 weeks
Medicine consumption
Time frame: 52 weeks
Patient expectations
Time frame: At inclusion
Success rate
Time frame: 52 weeks
Arm pain
Time frame: 52 weeks

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 19 Dec 2024.
Derived from this study: PubMed 40130970Taso M, Sommernes JH, Sundseth J, Pripp AH, Bjorland S, Engebretsen KB, Kolstad F, Zwart JA, Brox JI. Surgical versus Nonsurgical Treatment for Cervical Radiculopathy. NEJM Evid. 2025 Apr;4(4):EVIDoa2400404. doi: 10.1056/EVIDoa2400404. Epub 2025 Mar 25.
Derived from this study: PubMed 35551484Taso M, Sommernes JH, Bjorland S, Zwart JA, Engebretsen KB, Sundseth J, Pripp AH, Kolstad F, Brox JI. What is success of treatment? Expected outcome scores in cervical radiculopathy patients were much higher than the previously reported cut-off values for success. Eur Spine J. 2022 Oct;31(10):2761-2768. doi: 10.1007/s00586-022-07234-7. Epub 2022 May 13.
Derived from this study: PubMed 32178655Taso M, Sommernes JH, Kolstad F, Sundseth J, Bjorland S, Pripp AH, Zwart JA, Brox JI. A randomised controlled trial comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy. BMC Musculoskelet Disord. 2020 Mar 16;21(1):171. doi: 10.1186/s12891-020-3188-6.

Related trials for Cervical Radiculopathy

Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
RecruitingObservational study
Gelified Radiopaque Ethanol (Absolute Gel) in Cervical Disc Herniation: an Observational Study in Routine Clinical Practice (GENESIS)
Cervical Disc Herniation, Intervertebral Disc Displacement

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.

Jens Ivar Brox, MD PhD study chair

Oslo University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Anterior discectomy and Conservative treatment in people with Cervical Radiculopathy, run by Oslo University Hospital at 1 site in 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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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?

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: Follow-up at 52 weeks is the primary end point.). 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 NCT03674619, which also lists 3 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 19 Dec 2024.