Trial Outcomes & Findings for Evaluation of Comfort in a Spinal Collar (NCT NCT04066686)

Results Overview

'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable)

Recruitment status

COMPLETED

Target enrollment

27 participants

Primary outcome timeframe

During inpatient admission (an average of two weeks)

Results posted on

2021-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	14	13
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Young n=12 Participants Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old	Elderly n=13 Participants Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=13 Participants	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants	0 Participants n=13 Participants	12 Participants n=25 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants	13 Participants n=13 Participants	13 Participants n=25 Participants
Age, Continuous	47 years n=12 Participants	75 years n=13 Participants	65.5 years n=25 Participants
Sex: Female, Male Female	1 Participants n=12 Participants	6 Participants n=13 Participants	7 Participants n=25 Participants
Sex: Female, Male Male	11 Participants n=12 Participants	7 Participants n=13 Participants	18 Participants n=25 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	12 participants n=12 Participants	13 participants n=13 Participants	25 participants n=25 Participants

PRIMARY outcome

Timeframe: 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.

'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable)

Outcome measures

Outcome measures
Measure	Young n=11 Participants Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old	Elderly n=9 Participants Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age.
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 Interval 0.0 to 8.0	4.9 score on a scale Interval 0.0 to 9.0

SECONDARY outcome

Timeframe: 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).

'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.

Outcome measures

Outcome measures
Measure	Young n=10 Participants Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old	Elderly n=6 Participants Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age.
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 Interval 0.0 to 30.0	6.28 percentage score on a scale Interval 0.0 to 17.7
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 Interval 0.0 to 78.0	35.67 percentage score on a scale Interval 4.0 to 62.5

SECONDARY outcome

Timeframe: Through study completion, up to one year

Population: Data not available

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.

Outcome measures

Outcome data not reported

Adverse Events

Young

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Elderly

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Annabelle Lee

Imperial College Healthcare NHS Trust

Phone: 02033121077

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place