The influence of a soft cervical orthosis on pain after surgical therapy for subaxial cervical spine injuries - a randomized controlled trial

Not Applicable

Conditions: Fracture of neck
Dislocation, sprain and strain of joints and ligaments at neck level
S13
S12

Registration Number: DRKS00026935

Lead Sponsor: BG Klinik Ludwigshafen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting stopped after recruiting started

Sex: All

Target Recruitment: 1

Inclusion Criteria

• at least 18 years
• Subaxial cervical spine injury without spinal cord injury requiring surgical therapy
• Speech and reading comprehension sufficient to understand the study and outcome questionnaires
• Consent to study participation and data collection and processing

Exclusion Criteria

• under 18 years of age
• Spinal cord injury
• Previous diseases of the cervical spine:
o Symptomatic spinal stenosis
o previous operations
o Stiffening diseases (SpA, DISH)
o tumor
o infection
• The following serious accompanying injuries:
o Moderate and severe traumatic brain injury
o Upper cervical spine injury with need for surgical therapy or need for conservative therapy in a cervical orthosis
• Insufficient understanding of the study and outcome questionnaires
• Refusal to participate

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Neck pain on visual analog scale 5 weeks postoperatively<br>2. Neck pain on visual analog scale 6 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Range of motion of cervical spine 5 weeks and 6 months postoperatively, health related quality of life and disability due to neck pain 5 weeks and 6 months postoperatively via SF-36 and Neck-Disability-Index, occurence of complications (wound healing, loss of reposition, failure of healing and others) within 6 months