Cervical Radiculopathy Trial — CRT  

Cervical Radiculopathy Clinical Trial

Official title: A Randomised Controlled Trial Comparing the Effectiveness of Surgical and Nonsurgical Treatment for Cervical Radiculopathy

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

• NCT number: NCT03674619
• Study type: Interventional
• Source: Oslo University Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 19, 2018
• Completion date: January 31, 2028