Cervical Radiculopathy Trial (CRT)
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|ClinicalTrials.gov Identifier: NCT03674619|
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : December 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cervical Radiculopathy||Procedure: Anterior discectomy Behavioral: Conservative treatment||Not Applicable|
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) and arm pain 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||A Randomised Controlled Trial Comparing the Effectiveness of Surgical and Nonsurgical Treatment for Cervical Radiculopathy|
|Actual Study Start Date :||October 19, 2018|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
Active Comparator: Surgical treatment
Procedure: 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.
Active Comparator: Conservative treatment
Patients will attend an experienced specialist in physical medicine and rehabilitation and a physiotherapist.
Behavioral: 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 in the disc herniation study and 6-12 sessions in the spondylosis study) and provide advice on how to handle secondary neck muscle pain and dysfunction, reduce eventual fear avoidance, and advice to stay active.
- 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.
- Numeric rating scale (NRS) [ Time Frame: Follow-up at 52 weeks is the primary end point. ]Arm pain and neck pain score on two separate Numeric Rating Scales (NRS) from 0 (no pain to 10 (worst imaginable pain).
- EuroQol (EQ-5D-5L and EQ-VAS) [ Time Frame: 52 weeks ]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.
- Fear-avoidance beliefs [ Time Frame: 52 weeks ]Evaluated with the Fear Avoidance Beliefs Questionnaire
- Emotional distress [ Time Frame: 52 weeks ]Assessed by the 10-question version of the Hopkins Symptom Check List
- Perceived recovery [ Time Frame: 52 weeks ]Perceived recovery or change of the main symptom rated on a numeric scale ranging from -9 (worst possible change) to 9 (best possible change)
- Sickness absence data [ Time Frame: 52 weeks ]Sickness absence data will be collected from the National Social Security Institution for the year before and after inclusion.
- Dysphagia [ Time Frame: 52 weeks ]As recorded by The Dysphagia Short Questionnaire
- Medicine consumption [ Time Frame: 52 weeks ]Questions related to pain medication usage.
- Patient expectations [ Time Frame: At inclusion ]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.
- Success rate [ Time Frame: 52 weeks ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674619
|Contact: Mirad Taso, MDfirstname.lastname@example.org|
|Contact: Jon Håvard Sommernes, MDemail@example.com|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0424|
|Contact: Mirad Taso, MD +4793838735 firstname.lastname@example.org|
|Contact: Jon Håvard Sommernes, MD +4790823849 email@example.com|
|Study Chair:||Jens Ivar Brox, MD PhD||Oslo University Hospital|