Evaluation of Comfort in a Spinal Collar

July 1, 2021 updated by: Imperial College Healthcare NHS Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 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)
During inpatient admission (an average of two weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 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.
At baseline (retrospectively) and at time of wearing the spinal collar after injury
Measurement of Spinal Angulation
Time Frame: 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.
Through study completion, up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College Healthcare NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Fertleman, Study Principal Investigator Imperial College Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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