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Evaluation of Comfort in a Spinal Collar

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066686
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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.
Actual Study Start Date : October 26, 2018
Actual Primary Completion Date : May 29, 2019
Actual Study Completion Date : May 29, 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Measurement of the level of discomfort produced by the spinal collar in adult patient with a C-spine (neck) injury. [ Time Frame: throughout study completion, an average of 2 weeks ]
    'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable)


Secondary Outcome Measures :
  1. 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: baseline, time of wearing the spinal collar after injury, an avarange of 2 weeks ]
    'Neck Disability Index' Questionnaire (Validated functional assessment which consists of ten questions in questionnaire format with multi-choice answer options). Maximum score is 50, best option score is 0, the worst is 5. The score is calculated as follows: Example - 16 (total scored) 50 (total possible score) x 100 = 32%. 100% means no improvement.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066686


Locations
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United Kingdom
Imperial College Heathcare NHS Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: Michael Fertleman Study Principal Investigator Imperial College Healthcare NHS Trust
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Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT04066686    
Other Study ID Numbers: 18SM4650
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College Healthcare NHS Trust:
Neck Injuries
Additional relevant MeSH terms:
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Neck Injuries
Wounds and Injuries