Cervical Radiculopathy Trial (CRT)

University of Oslo (UIO)

Status

Active, not recruiting

Conditions

Cervical Radiculopathy

Treatments

Behavioral: Conservative treatment

Procedure: Anterior discectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03674619

2017/2125

Details and patient eligibility

About

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.

Full 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:
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)
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.

Enrollment

180 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.