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Evaluation of Comfort in a Spinal Collar

I

Imperial College Healthcare NHS Trust

Status

Completed

Conditions

Neck Injuries

Study type

Observational

Funder types

Other

Identifiers

NCT04066686
18SM4650

Details and patient eligibility

About

This is an observational study which aims to assess the comfort of a spinal collar in patients who have them fitted as part of their clinical care due to neck injury.

Full description

The study follows the patient journey including long term follow up (up to 120 days following admission). The information gathered will be from the standard clinical care delivered and include demographics, baseline function, the injuries sustained following trauma and prescribed analgesia with records of the most recent time and dose administered. Any scans done of the neck for clinical purposes will be anonymised and analysed for measurements of angulation. In addition to this there will be a survey on the comfort of the collar and of their functional ability at the current time at various points during their inpatient admission.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. All patients aged 18yrs and over with a C-spine injury immobilised in a spinal collar
  2. Patients must be nursed on Major Trauma Ward
  3. Ability to give informed consent to participate in the study.

Exclusion criteria

  1. Patients under 18yrs age
  2. Patients who lack capacity to consent for entry into the study
  3. Patients who are receiving level 2( High dependency unit) or level 3 (Intensive care unit) clinical care
  4. Patients who are unable to complete the visual analogue score or questionnaire due to having co-existent severe hearing and visual impairment. Severe hearing impairment will be defined as unable to hear the researcher with hearing aids if required. Severe visual impairment will be defined as being unable to read the patient information sheet even with visual aids.
  5. Patients unable to understand the patient leaflet in English.

Trial design

27 participants in 2 patient groups

Young
Description:
Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old
Elderly
Description:
Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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