Evaluation of Comfort in a Spinal Collar

NCT04066686 | Completed Results

• 1 other identifier: 18SM4650
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Injuries

Keywords

Neck Injuries

Outcome Measures

Primary Outcomes (1)

• 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)

  During inpatient admission (an average of two weeks)

Secondary Outcomes (2)

• 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

• Measurement of Spinal Angulation

  Through study completion, up to one year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• All patients aged 18yrs and over with a C-spine injury immobilised in a spinal collar
• Patients must be nursed on Major Trauma Ward
• Ability to give informed consent to participate in the study.

You may not qualify if:

• Patients under 18yrs age
• Patients who lack capacity to consent for entry into the study
• Patients who are receiving level 2( High dependency unit) or level 3 (Intensive care unit) clinical care
• 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.
• Patients unable to understand the patient leaflet in English.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Imperial College Heathcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Neck Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Dr Annabelle Lee
• Organization: Imperial College Healthcare NHS Trust

annabellelee@nhs.net

02033121077

Study Officials

• Michael Fertleman

  Study Principal Investigator Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 26, 2019
• Study Start: October 26, 2018
• Primary Completion: May 29, 2019
• Study Completion: May 29, 2019
• Last Updated: July 22, 2021
• Results First Posted: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)