Evaluation of Comfort in a Spinal Collar

Neck Injuries Clinical Trial

Official title:

Evaluation on the Level of Discomfort and Restriction on Activities of Daily Living (ADLs) Whilst C-spine Immobilised in a Spinal Collar After C-spine Injury.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04066686
• Other study ID #: 18SM4650
• Status: Completed
• Start date: October 26, 2018
• Est. completion date: May 29, 2019

Study information

• Verified date: July 2021
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 29, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neck Injuries

Locations

Country	Name	City	State
United Kingdom	Imperial College Heathcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the Level of Discomfort Produced by the Spinal Collar in Adult Patients With a C-spine (Neck) Injury.	'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable)	During inpatient admission (an average of two weeks)
Secondary	Measurement of Change of Impedance on Activities of Daily Living Produced by the Spinal Collar in Adult Patient With a C-spine (Neck) 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.	At baseline (retrospectively) and at time of wearing the spinal collar after injury
Secondary	Measurement of Spinal Angulation	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.	Through study completion, up to one year