Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
60 participants
OBSERVATIONAL
2022-01-19
2025-01-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Attending
* Resident
* Physician assistant, nurse practitioner, or nurse
* EMS/Paramedic
* Other, as determined by job functions in pre-assessment
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Collar Immobilization Following a Posterior Cervical Laminectomy and Fusion
NCT01383876
Evaluation of Comfort in a Spinal Collar
NCT04066686
Joint Mobilization vs. Strengthening Exercises on Cervical Proprioception for Nonspecific Neck Pain
NCT06960525
Effects of Weight of Dress Shirt on Arthrokinematics of Cervical Spine in Healthy Females
NCT06669871
The Effects of Cervical Spine Manipulation On Postural Control
NCT00524654
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Attending
* Resident
* Physician assistant, nurse practitioner, or nurse
* EMS/Paramedic
* Other, as determined by job functions in pre-assessment Prior to placing C-collars, provider volunteers who will be placing C-collars will answer a questionnaire about their medical experience, their current position, their confidence in effective C-collar placement, and if they had formal C-collar training (Appendix D).
Healthy C-spine volunteers will lie supine. Cameras will be placed directly superior, anterior, and lateral to the volunteer's head. C-spine volunteers will be asked to actively move their head to the maximal flexion, extension, bilateral rotation, and bilateral side bending to assess baseline ROM.
Provider volunteers will individually place a C-collar on the C-spine volunteer's neck. They will have a range of sizes to choose from or adjustable units as applicable. The provider volunteer will be able to independently select and adjust a collar to best fit the C-spine volunteer.
The C-spine volunteer will then actively move their head to the maximal flexion, extension, bilateral rotation, and bilateral side bending with the C-collar on. ROM will be analyzed from video taken. This process will be repeated for each C-spine volunteer and each provider volunteer (Minimum 3 volunteers per 1 provider volunteer).
The angle of ROM in flexion, extension, rotation, and side bending without and with C-collar placement in each video will be measured using image analysis software. The decrease in ROM while wearing the C-collar for each encounter will be calculated. Scoring of C-collar placement will be done by an investigator while the provider volunteer is placing the C-collar. Providers will then receive additional information and resources specific to C-collar make/model placement and asked to complete a short survey (Appendix E) related to the content provided.
Provider volunteers will then have training on correct sizing and placing of C-collars and be reassessed in the same manor described above. Percent change will then be calculated for each volunteer provider.
This is a prospective interventional trial with healthy volunteers at Methodist Dallas Medical Center. We anticipate data collection to be completed by December 2023. All study participants will be consented regardless of their role as healthy C-spine volunteer or provider volunteer (Appendix C). No compensation will be provided. Provider volunteers will be classified as:
* Attending
* Resident
* Physician assistant, nurse practitioner, or nurse
* EMS/Paramedic
* Other, as determined by job functions in pre-assessment Prior to placing C-collars, provider volunteers who will be placing C-collars will answer a questionnaire about their medical experience, their current position, their confidence in effective C-collar placement, and if they had formal C-collar training (Appendix D).
Healthy C-spine volunteers will lie supine. Cameras will be placed directly superior, anterior, and lateral to the volunteer's head. C-spine volunteers will be asked to actively move their head to the maximal flexion, extension, bilateral rotation, and bilateral side bending to assess baseline ROM.
Provider volunteers will individually place a C-collar on the C-spine volunteer's neck. They will have a range of sizes to choose from or adjustable units as applicable. The provider volunteer will be able to independently select and adjust a collar to best fit the C-spine volunteer.
The C-spine volunteer will then actively move their head to the maximal flexion, extension, bilateral rotation, and bilateral side bending with the C-collar on. ROM will be analyzed from video taken. This process will be repeated for each C-spine volunteer and each provider volunteer (Minimum 3 volunteers per 1 provider volunteer).
The angle of ROM in flexion, extension, rotation, and side bending without and with C-collar placement in each video will be measured using image analysis software. The decrease in ROM while wearing the C-collar for each encounter will be calculated. Scoring of C-collar placement will be done by an investigator while the provider volunteer is placing the C-collar. Providers will then receive additional information and resources specific to C-collar make/model placement and asked to complete a short survey (Appendix E) related to the content provided.
Provider volunteers will then have training on correct sizing and placing of C-collars and be reassessed in the same manor described above. Percent change will then be calculated for each volunteer provider.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Methodist Dallas Medical Center (MDMC) staff
* 18+ years old
* Full ROM of C-spine
Provider Volunteers:
* Medical provider with permissions at MDMC
* C-collar placement in regular job duties
Exclusion Criteria
* \<18 years old
* C-spine trauma
* Previous neck or C-spine surgeries
* Abnormal limitations to C-spine ROM
* Pregnant/nursing
* Claustrophobia
* Pulmonary dysfunction
Provider Volunteers:
• No previous experience placing C-collars
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Methodist Health System
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Conner McDaniel, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Methodist Dallas Medical Center
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
071.TRA.2021.D
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.