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Is it possible to conduct a study to compare using and not using a rigid neck collar to immobilise the neck in adults who have potentially injured the spinal cord in their neck?

Spinal Motion Restriction Feasibility (SMRF) study: A prospective, randomised, two-centre, comparative study to determine if there is a difference in clinical outcomes and patient experience comparing Spinal Motion Restriction techniques which include the traditional use of a rigid cervical spine collar versus the omission of a rigid collar.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11400471
Enrollment
200
Registered
2020-02-04
Start date
2020-08-10
Completion date
Unknown
Last updated
2021-09-13

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

Conditions

Use of a rigid collar in patients who have a potential cervical spinal cord injury following trauma Injury, Occupational Diseases, Poisoning

Interventions

Participants will be pre-randomised based on the hospital sites they are attending. Initially the two participating sites will be randomised to either intervention or control site. After 6 months dura

Sponsors

North East Ambulance Service NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and older 2. Transported by North East Ambulance Service crew to either participating Emergency Department 3. Any of the following conditions apply: 3.1. Participant has had a mechanism of injury and clinical assessment suggestive of SCI. Example mechanisms include (but are not exclusive to) road traffic collisions, falls from height and serious assaults. In the elderly or frail patient, this may include a fall from standing height and should be based on a thorough clinical exam 3.2. Participant has symptoms consistent with cervical spine injury. For older patients any neck pain, including muscular, should be considered as suspicious for cervical spine injury. 3.3. Participants with dementia/delirium who are unable to communicate reliably regarding potential injury and have significant head injury, as they are at risk of potential cervical spine injury and should be included in the study

Exclusion criteria

Exclusion criteria: 1. Requires airway support for whatever reason 2. Glasgow Coma Score < 13 (reduced conscious level) 3. Displaying obvious signs of new neurological injury, such as paralysis 4. Significant facial injuries that may benefit from the support a rigid collar may provide 5. Already immobilised with a rigid collar by a non-study clinician or third party provider prior to intervention group clinician assessment

Design outcomes

Primary

MeasureTime frame
1. Time in minutes from paramedics' arrival on scene to time leaving scene (on-scene time) assessed using North East Ambulance Service EMS 999 automated vehicle resource log. Data extrapolated within 7 days of incident. 2. Time in minutes from arrival in Emergency Department to the patient receiving a cervical spine imaging in the Emergency Department assessed using North East Ambulance Service EMS 999 automated vehicle resource log and date/time stamp on CT/imaging report (Care Stream). Data extrapolated within 7 days of incident. 3. Presence of gross neurological changes initially assessed by Emergency Department staff as a baseline using the NICE 2016 guidelines (https://www.nice.org.uk/guidance/ng41/resources/spinal-injury-assessment-and-initial-management-pdf-1837447790533 ). This data is reported within the trauma document. 4. Presence of fractures or other physiological injury as reported in trauma assessment and imaging reports within 7 days of assessment/imaging and reported within Care Stream and the trauma document. 5. Severity of pressure ulcers or other tissue viability problems assessed using the International NPUAP EPUAP Pressure Ulcer Classification System within the Emergency Department assessed and reported within the nursing notes of the trauma document prior to discharge from Emergency Department. 6. Participant compliance assessed and reported (compliant/non-compliant) by clinician during initial management at time of application/non-application of collar and reported within the electronic patient care record (Safe Triage)

Secondary

MeasureTime frame
All secondary outcome measures will be recorded using a participant experience questionnaire scored using a Likert scale within 72 h. 1. Comfort during neck immobilisation 2. Pain during neck immobilisation 3. Understanding of procedure 4. Complications (e.g. anxiety, breathing difficulties)

Countries

England, United Kingdom

Outcome results

None listed

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