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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00026935
Enrollment
70
Registered
2021-11-11
Start date
2022-01-12
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

S12 S13

Interventions

Group 1: Use of a soft cervical collar for 5 weeks postoperatively Group 2: No use of cervical collar postoperatively

Sponsors

BG Klinik Ludwigshafen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Neck pain on visual analog scale 5 weeks postoperatively 2. Neck pain on visual analog scale 6 months postoperatively

Secondary

MeasureTime frame
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

Countries

Germany

Contacts

Public ContactPhilipp Raisch

BG Klinik Ludwigshafen

philipp.raisch@bgu-ludwigshafen.de062168102000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026