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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46954
Enrollment
200
Registered
2012-05-02
Start date
2012-05-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

radicular arm pain

Interventions

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

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age 18-75 years - Cervical radicular syndrome in one arm for at least 2 months - Radiographic diagnosis of cervical disc herniation - Informed consent

Exclusion criteria

Exclusion criteria: - Signs of myelopathy - Severe paresis (MCR

Design outcomes

Primary

MeasureTime frame
Measurements will take place at 6 weeks, 3, 6, 9, 12 and 24 months. The primary outcome is the VAS score for arm pain.

Secondary

MeasureTime frame
Secondary outcome is the timing of surgery in according the duration of the symptoms. Secondary parameters are the LCRSF (Leiden CRS Functioning Scale) VAS neck pain, perceived recovery (Likert), SF36, EuroQol, VAS quality of life, IPQ-K, DS-14, WOMAC, MRI findings, re-operation frequency, and cost diaries. The economical evaluation will be a cost utility analysis from a societal perspective, based on patient reports.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)