40 Participants Needed

Cervigard Neck Collar for Neck Pain

NH
Overseen ByNathan Hogaboom, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Kessler Foundation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Cervigard neck collar, a device designed to help military personnel with posture-related neck pain. The collar supports the neck to reduce pain, improve function, and correct spine curvature. Participants will use the collar regularly and provide feedback on their pain and function, with medical imaging used to measure changes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing the neck collar, so you might be able to continue your usual treatments, but it's best to confirm with the trial organizers.

How does the Cervigard Neck Collar treatment differ from other treatments for neck pain?

The Cervigard Neck Collar is unique because it specifically targets forward head posture (FHP), which is a common cause of neck pain. Unlike other treatments that may focus on general pain relief, this collar aims to correct posture, potentially addressing the root cause of the pain.12345

Are You a Good Fit for This Trial?

This trial is for active-duty military personnel aged 18-45 with neck pain lasting over 3 months, rated at least a 4 out of 10 on the pain scale. They must have forward head posture and not found relief from conventional treatments. Excluded are those with recent tumors, infections in the neck, generalized disorders affecting vertebrae, healing fractures, spinal deformities or conditions that make participation unsafe.

Inclusion Criteria

DEERS Eligible
I have had neck pain for over 3 months without nerve issues and have seen a doctor.
My head leans forward compared to my shoulders.
See 3 more

Exclusion Criteria

I have a health condition that weakens my neck bones or tissues.
Medical and/or psychological condition that would preclude safe participation
I had a tumor in my neck or head area in the last 6 months.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants are fitted with the Cervigard neck collar and instructed to wear it daily. Self-reported neck pain and function measures, as well as cervical X-Rays, are collected.

6 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with additional cervical X-Rays and questionnaires.

6 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cervigard Neck Collar
Trial Overview The study tests the Cervigard Neck Collar's effectiveness and safety in treating posture-related neck pain among military members. Participants will be randomly assigned to receive the collar immediately or after six weeks and will use it daily while their pain, function, and cervical spine alignment are monitored through questionnaires and X-rays over a period of up to twelve weeks.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Cervigard Neck Collar, which is a device used to treat neck pain caused by forward head posture.
Group II: Waitlist ControlActive Control1 Intervention
This group will receive no intervention for 6 weeks after enrollment. They will receive the device after 6 weeks.

Cervigard Neck Collar is already approved in United States for the following indications:

🇺🇸
Approved in United States as Cervigard Neck Collar for:
  • Neck pain due to forward head posture

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials
190
Recruited
11,300+

The Geneva Foundation

Collaborator

Trials
39
Recruited
13,700+

Walter Reed National Military Medical Center

Collaborator

Trials
149
Recruited
33,800+

Uniformed Services University of the Health Sciences

Collaborator

Trials
130
Recruited
91,100+

Geneva Foundation

Collaborator

Trials
4
Recruited
9,000+

Published Research Related to This Trial

The study found a moderate correlation between the craniovertebral angle (CVA) in the sagittal plane and the angle formed between the sternum and the tragi in the frontal plane, suggesting that frontal plane measurements can help assess forward head posture (FHP).
In both men and women, factors like height, weight, BMI, and hours spent on digital devices were negatively correlated with CVA, indicating that these factors may influence the severity of FHP.
Correlation between craniovertebral angle in the sagittal plane and angles and indices measured in the frontal plane at the moment of inducing forward head posture.Molaeifar, S., Yazdani, F., Yoosefinejad, AK., et al.[2021]
In a study of 101 office workers, forward head posture (FHP) and increased thoracic kyphosis were found to be associated with neck pain, particularly when in a working position.
However, shoulder posture did not show a significant correlation with neck pain, suggesting that not all postural issues contribute to this type of discomfort.
The relationship of forward head posture and rounded shoulders with neck pain in Iranian office workers.Nejati, P., Lotfian, S., Moezy, A., et al.[2021]
This systematic review aims to evaluate the effectiveness of interventions targeting forward head posture (FHP) in individuals with mechanical neck pain (MNP), focusing on randomized controlled trials and quasi-experimental studies.
The review will assess various outcomes, including postural changes, neck pain relief, functional disability, and quality of life, using rigorous methods to ensure the reliability of the findings.
Effectiveness of posture-correction interventions for mechanical neck pain and posture among people with forward head posture: protocol for a systematic review.Balthillaya, GM., Parsekar, SS., Gangavelli, R., et al.[2022]

Citations

Correlation between craniovertebral angle in the sagittal plane and angles and indices measured in the frontal plane at the moment of inducing forward head posture. [2021]
The relationship of forward head posture and rounded shoulders with neck pain in Iranian office workers. [2021]
Effectiveness of posture-correction interventions for mechanical neck pain and posture among people with forward head posture: protocol for a systematic review. [2022]
A Comparison of Two Forward Head Posture Corrective Approaches in Elderly with Chronic Non-Specific Neck Pain: A Randomized Controlled Study. [2023]
The Relationship Between Forward Head Posture and Neck Pain: a Systematic Review and Meta-Analysis. [2020]
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