Evaluation of Comfort in a Spinal Collar

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-26

Study Completion Date

2019-05-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Measurements of Angulation of the C-spine

NCT03958149

Cervical Spine

COMPLETED NA

Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion

NCT01383876

Cervical Spondylosis Symptomatic Neurological Compression

TERMINATED NA

In Vivo Quantification of Cervical Collar Efficacy

NCT05262140

Spine Injury

RECRUITING

Evaluation of the Nursing C-Spine (Phase IV)

NCT01353352

Fracture of Cervical Spine Fracture Dislocation of Cervical Spine

COMPLETED PHASE4

Evaluation of Splinting in Tetraplegia

NCT04523636

Spinal Cord Injury Cervical Splints

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neck Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Young

Participants recruited into one of two groups on age stratification. Young cohort defined as aged 18-65yrs old

No interventions assigned to this group

Elderly

Participants recruited into one of two groups on age stratification. Elderly cohort defined as over 65yrs of age.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No