Neck Injuries
Conditions
Keywords
Neck Injuries
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.
Interventions
None listed
Sponsors
Imperial College Healthcare NHS Trust
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Young Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old | 12 |
| Elderly Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age. | 13 |
| Total | 25 |
Baseline characteristics
| Characteristic | Elderly | Total | Young |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 13 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 12 Participants | 12 Participants |
| Age, Continuous | 75 years | 65.5 years | 47 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 13 participants | 25 participants | 12 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 1 Participants |
| Sex: Female, Male Male | 7 Participants | 18 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
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)
Time frame: During inpatient admission (an average of two weeks)
Population: 11 Young participants and 9 Elderly participants completed the visual analogue score (some participants chose not to complete the score). Visual analogue score was assessed at single time point during the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Young | Measurement of the Level of Discomfort Produced by the Spinal Collar in Adult Patients With a C-spine (Neck) Injury. | 1 score on a scale |
| Elderly | Measurement of the Level of Discomfort Produced by the Spinal Collar in Adult Patients With a C-spine (Neck) Injury. | 4.9 score on a scale |
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.
Time frame: At baseline (retrospectively) and at time of wearing the spinal collar after injury
Population: Only 10 participants in the Young group and 6 participants in the Elderly group were able to complete the 'Neck Disability Index' Questionnaires (retrospectively for baseline and at the time of wearing the spinal collar after injury).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Young | 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 | 8.99 percentage score on a scale |
| Young | Measurement of Change of Impedance on Activities of Daily Living Produced by the Spinal Collar in Adult Patient With a C-spine (Neck) Injury. | Wearing the spinal collar after injury | 50.83 percentage score on a scale |
| Elderly | 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 | 6.28 percentage score on a scale |
| Elderly | Measurement of Change of Impedance on Activities of Daily Living Produced by the Spinal Collar in Adult Patient With a C-spine (Neck) Injury. | Wearing the spinal collar after injury | 35.67 percentage score on a scale |
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.
Time frame: Through study completion, up to one year
Population: Data not available