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

Recruiting

• Conditions: radicular arm pain; cervical disc herniation; 10009720; 10028377; 10041543

• Registration Number: NL-OMON46954
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 200

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

- Signs of myelopathy
- Severe paresis (MCR <= 3)
- Cervical spine surgey in the past
- Instability of the cervical spinal column requiring stabilisation
- Pregnancy
- Severe life-threatening or psychiatric illness
- Insufficient knowledge of Dutch language
- Planned emigration in the year after randomization

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Measurements will take place at 6 weeks, 3, 6, 9, 12 and 24 months. The primary<br /><br>outcome is the VAS score for arm pain. </p><br>

Secondary Outcome Measures

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