Evaluation of Comfort in a Spinal Collar

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.

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.

Study Overview

• Status: Completed
• Conditions: Neck Injuries

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 Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Imperial College Heathcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients aged 18yrs and over who are admitted to St Mary's Hospital with a C-spine injury will be invited to participate

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Young; Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old
Elderly; Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust
• Investigators: Principal Investigator: Michael Fertleman, Study Principal Investigator Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2018
• Primary Completion (Actual): May 29, 2019
• Study Completion (Actual): May 29, 2019

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Neck Injuries
• Additional Relevant MeSH Terms: Wounds and Injuries; Neck Injuries
• Other Study ID Numbers: 18SM4650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No