Effectiveness of surgery versus prolonged conservative care in patients suffering from a herniated cervical disc

The cervical radicular syndrome (CRS), being caused by a cervical hernis nuclei
pulposi (HNP), is a frequently occuring problem. The CRS causes radiating pain
in the arm, and often has an intensity that prohibits normal functioning. Apart
from that, motor and/or sensory deficits can accompany this pain. In the
majority of patients with these complaints, the symptons gradually diminish
within weeks to such an extent that the normal way of live can be continued.
If however the complaints do not diminish spontaneously, or not within
reasonable time, the patient will be referred to the neurologist and
subsequently to the neurosurgeon to judge a surgical intervention. The surgical
intervention consist a discectomy, at which the bulging part of the disc,
compressing the spinal root, can be taken out.
CRS is a disease for which both conservative therapy and surgical therapy could
provide a good result. However, it is unknown whether early neurosurgical
intervention or prolonged conservative care is more effective or more
cost-effective. In the present study, the effectiveness of timing of the
anterior discectomy will be studied. This investigation concerns an
intervention that is considered to be 'usual care' of which the timing is under
discussion.

It is required to compare results from conservative- and surgical treatment in
The Netherlands and to perform an economic evaluation in order to evaluate the
cost-effectivity of both treatment types. On one hand, surgical treatment seems
accompanied by high costs, but also by less absenteeism, compared to prolonged
conservative care.

This allows for formulation of the following research question:

Primary question:
What is the effect of choosing conservative care vs surgical treatment on
clinical parameters one and two years after follow-up?

Subquestions:
- Which factors identify patients choosing for a specific treatment type?
- Are these identifying factors after one- and two years follow-up comparable
in both groups?
- Is there a difference between patients undergoing early- vs late surgery?
- Value based health care: is there a difference in cost-effectiveness between
groups (conservative vs. early surgery vs. surgery)?

The present project is a prospective study with two-year follow-up and repeated
measurements. Patients are eligible for inclusion between ages 18-75, with
persisting cervical radicular syndome for more than two months. The Leiden
University Medical Center will provide as data coordination center. Here, data
will be collected, analyzed and preserved.

In both arms of the study the treatment is according to *usual care*.

This means for the conservative group mainly pain medication. In order to let
patients maintain their conservative treatment it is important to reduce
anxiousness of the patients and repeated explanations on the gunstige prognosis
of the CRS. It is not usual to prescribe a soft collar and/or fysiotherapy to
patients suffering from a CRS, but when the family doctor deems this preferable
to the begeleding van de patient it can be prescribed.

Patients in the surgery group will be operated within 4 weeks. The surgeon is
free to use the manner he/she likes, as long as it is filled in on a standaard
way.

Participation in the present study does not a special risk.