Evaluation of Comfort in a Spinal Collar

Completed

• Conditions: Neck Injuries

• Registration Number: NCT04066686
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-10-26
• Primary Completion: 2019-05-29
• Study Completion: 2019-05-29
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-26
• Results First Submitted: 2021-01-18
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Results First Posted: 2021-07-22
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of the Level of Discomfort Produced by the Spinal Collar in Adult Patients With a C-spine (Neck) Injury.	During inpatient admission (an average of two weeks)	'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Measurement of Change of Impedance on Activities of Daily Living Produced by the Spinal Collar in Adult Patient With a C-spine (Neck) Injury.	At baseline (retrospectively) and at time of wearing the spinal collar after injury	'Neck Disability Index' Questionnaire (Validated functional assessment which consists of ten questions to assess how that persons neck pain affects abilities in everyday life. It is a questionnaire format with multi-choice answer options). Minimum score = 0, Maximum score = 50. The overall percentage score is calculated as follows: e.g. 16 (total scored) divided by 50 (total possible score) x 100 = 32%. A higher percentage indicates a worse outcome i.e. higher disability.
Measurement of Spinal Angulation	Through study completion, up to one year	Measurements of angulation between specified bony anatomical landmarks to investigate degree of curvature within the C-spine performed on any neck imaging completed as part of routine clinical care. Statistical analysis to allow comparison of young and elderly groups.

Trial Locations

Locations (1)

Imperial College Heathcare NHS Trust; 🇬🇧 London, United Kingdom