Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
180 participants
INTERVENTIONAL
2018-10-19
2028-01-31
Brief Summary
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Detailed Description
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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.
1. 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:
1. Study 1: one level disc herniation (C5/6 or C6/7)
2. Study 2: one or two level spondylosis (C5/6 and/or C6/7)
2. 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).
3. To estimate cost-effectiveness for health care costs and societal costs (including sickness absence) in surgical versus non-surgical patients.
4. 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 .
5. To evaluate treatment outcome expectations at baseline asking the patients to fill in their expected improvement.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Surgical treatment
Anterior discectomy
Anterior discectomy
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 treatment
Patients will attend an experienced specialist in physical medicine and rehabilitation and a physiotherapist.
Conservative treatment
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.
Interventions
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Anterior discectomy
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 treatment
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Signs of myelopathy;
* Rapidly progressive paresis or paresis \< grade 4;
* Pregnancy;
* Arthritis involving the cervical spine;
* Infection or active cancer;
* 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.
20 Years
65 Years
ALL
Yes
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Mirad Taso
MD
Principal Investigators
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Jens Ivar Brox, MD PhD
Role: STUDY_CHAIR
Oslo University Hospital
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017/2125
Identifier Type: -
Identifier Source: org_study_id