Clinical trial NCT03674619: Cervical Radiculopathy Trial
Official title: A Randomised Controlled Trial Comparing the Effectiveness of Surgical and Nonsurgical Treatment for Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Radiculopathy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) 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.

Eligibility criteria: Inclusion Criteria:

* 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

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.

Primary outcomes:
measure: Neck Disability Index
timeFrame: Follow-up at 52 weeks is the primary end point.
Secondary outcomes:
measure: Neck pain
timeFrame: 52 weeks
measure: EuroQol (EQ-5D-5L and EQ-VAS)
timeFrame: 52 weeks
measure: Fear-avoidance beliefs
timeFrame: 52 weeks
measure: Emotional distress
timeFrame: 52 weeks
measure: Perceived recovery
timeFrame: 52 weeks
measure: Sickness absence data
timeFrame: 52 weeks
measure: Dysphagia
timeFrame: 52 weeks
measure: Medicine consumption
timeFrame: 52 weeks
measure: Patient expectations
timeFrame: At inclusion
measure: Success rate
timeFrame: 52 weeks
measure: Arm pain
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Jens Ivar Brox, MD PhD
role: STUDY_CHAIR
References:
citation: 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.