Cervigard Neck Collar for Neck Pain

Overseen By Nathan Hogaboom, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Tumor, Infection, Fracture, Deformities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new neck collar designed to alleviate neck pain, especially for those with posture-related discomfort. It targets active-duty military personnel who have experienced neck pain for over three months without relief from standard treatments. Participants will either begin using the Cervigard Neck Collar immediately or after a six-week delay. The trial will assess the collar's effectiveness in reducing pain and improving posture through surveys and X-rays. Individuals with neck pain affecting daily life, who have not found success with other treatments, may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore a new treatment option that could significantly enhance quality of life.

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.

What prior data suggests that the Cervigard neck collar is safe for treating neck pain?

Research shows that the Cervigard neck collar helps alleviate neck pain related to posture with minimal effort. The FDA has registered it, confirming it meets specific safety standards. An early study with regular people found that wearing the collar for six weeks reduced pain and improved head posture. This suggests that most people can use the device without problems. The initial research did not find any major side effects, indicating it is safe for most users. However, as testing continues, monitoring any new information remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Cervigard Neck Collar is unique because it specifically targets neck pain caused by forward head posture, a common issue not always addressed by standard treatments like physical therapy, pain relievers, or ergonomic adjustments. Unlike these options, which often require ongoing sessions or medication, the Cervigard Neck Collar offers a non-invasive, wearable solution that can be used conveniently throughout the day to provide relief and correct posture. Researchers are excited about its potential to offer a more practical and immediate approach to managing neck pain without the side effects or time commitments associated with other treatments.

What evidence suggests that the Cervigard neck collar is effective for treating neck pain?

Research has shown that the Cervigard Neck Collar can help reduce neck pain. In an initial 6-week study, participants with neck pain who wore the collar reported less pain and improved neck posture. The study also noted improvements in the natural curve of the neck, known as the lordotic curve. Wearing the collar for just 20 minutes a day eased neck and back pain and even reduced migraine pain for some participants. In this trial, participants in the intervention arm will use the Cervigard Neck Collar, while those in the waitlist control arm will receive no intervention for the first 6 weeks. These early results suggest that the Cervigard collar could be a promising option for managing neck pain related to posture. ^{2 4 5 6 7}

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.

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.

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?

Group I: Intervention Experimental Treatment 1 Intervention

Cervigard Neck Collar, which is a device used to treat neck pain caused by forward head posture.

Group II: Waitlist Control Active Control 1 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

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Adults with neck pain exhibit a significant increase in forward head posture (FHP) compared to asymptomatic individuals, with a mean difference of 4.84, indicating a clear relationship between FHP and neck pain in this population.

In adults and older adults, there are strong negative correlations between FHP and both neck pain intensity and disability, suggesting that greater FHP is associated with more severe neck pain, while this relationship is less evident in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between Forward Head Posture and Neck Pain: a Systematic Review and Meta-Analysis. Mahmoud, NF., Hassan, KA., Abdelmajeed, SF., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 66 elderly participants with forward head posture (FHP) and neck pain, the Chiropractic Biophyics® (CBP®) intervention led to significant improvements in craniovertebral angle (CVA) after 6 weeks, while the standard exercise group did not show similar postural improvements.

At a 3-month follow-up, the CBP group maintained significant improvements in pain intensity and functional outcomes, suggesting that correcting FHP may be crucial for long-term relief and better function, unlike the standard exercise group which experienced regression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Two Forward Head Posture Corrective Approaches in Elderly with Chronic Non-Specific Neck Pain: A Randomized Controlled Study. Suwaidi, ASA., Moustafa, IM., Kim, M., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. cervigard.com cervigard.com/blogs/news/safety-and-efficacy-of-a-novel-therapy-collar-for-forward-head-posture-and-chronic-neck-pain-in-active-duty-service-members

Safety and Efficacy of a Novel Therapy Collar for Forward Head ... Objectives: 1. Describe the impact of forward head posture (FHP) on neck pain. 2. Compare pain, function, and radiographic outcomes following FHP therapy collar ...

2. cervigard.com cervigard.com/products/the-cervigard%E2%84%A2-forward-head-posture-neck-collar

The Cervigard™ Forward Head Posture Neck Collar At least 20 minutes a day wearing the collar can effectively treat the cause, so the neck, back and even migraine pain goes away.

3. kesslerfoundation.org kesslerfoundation.org/press-release/treating-neck-pain-active-duty-military

Kessler Foundation studies new option for treating neck ... In a 6-week pilot study of the Cervigard FHP Neck Collar, civilians with neck pain showed decreased pain, improved lordotic curve, and reduced ...

4. withpower.com withpower.com/trial/phase-neck-pain-5-2022-8da51

Cervigard Neck Collar for Neck Pain Adults with neck pain exhibit a significant increase in forward head posture (FHP) compared to asymptomatic individuals, with a mean difference of 4.84, ...

5. cervigard.com cervigard.com/blogs/news/kessler-foundation-studies-efficacy-of-cervigard

Kessler Foundation Studies Efficacy of Cervigard A preliminary 6-week intervention among civilians who presented with neck pain showed reduced pain, improved lordodic curve, and reduced forward head posture.

6. ctv.veeva.com ctv.veeva.com/study/a-novel-device-for-neck-pain-in-active-duty-military-personnel-with-forward-head-posture

A Novel Device for Neck Pain in Active-duty Military Personnel ... The Cervigard neck collar was designed to treat posture-related neck pain with minimal effort and time required for treatment by the patient. ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05433025

A Novel Device for Neck Pain in Active-duty Military ... The Cervigard neck collar was designed to treat posture-related neck pain with minimal effort and time required for treatment by the patient. However, this has ...