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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
Sponsor:
Information provided by (Responsible Party):
Mirad Taso, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE September 14, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date December 5, 2018
Actual Study Start Date  ICMJE October 19, 2018
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03674619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cervical Radiculopathy Trial
Official Title  ICMJE A Randomised Controlled Trial Comparing the Effectiveness of Surgical and Nonsurgical Treatment for Cervical Radiculopathy
Brief Summary 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.
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.

  1. 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:

    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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cervical Radiculopathy
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Surgical treatment
    Anterior discectomy
    Intervention: Procedure: Anterior discectomy
  • Active Comparator: Conservative treatment
    Patients will attend an experienced specialist in physical medicine and rehabilitation and a physiotherapist.
    Intervention: Behavioral: Conservative treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 20 to 65 years.
  • Study 1: Neck and arm pain for 10-26 weeks and 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:

  • 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;
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mirad Taso, MD +4793838735 mirtas@ous-hf.no
Contact: Jon Håvard Sommernes, MD +4790823849 haasom@ous-hf.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03674619
Other Study ID Numbers  ICMJE 2017/2125
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mirad Taso, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jens Ivar Brox, MD PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP