What side effects are associated with this type of intervention?

Common treatments for neck pain that focus on posture correction and cervical lordosis improvement include physical therapy, spinal manipulation, and the use of orthotic devices like neck collars. Physical therapy and spinal manipulation can sometimes cause temporary discomfort, muscle soreness, or increased pain. Orthotic devices, such as neck collars, may lead to skin irritation, discomfort from prolonged use, and potential muscle weakness if used excessively. It is important to monitor for these side effects and consult with a healthcare provider to ensure safe and effective treatment.

What prior FDA approvals exist?

The FDA has approved various treatments for neck pain, including pharmacological agents like NSAIDs and muscle relaxants, physical therapy, and devices such as cervical collars and traction devices. However, specific FDA approvals for treatments focusing on posture correction and cervical lordosis improvement, similar to the Cervigard neck collar, are not detailed in the provided context. Generally, treatments for neck pain aim to reduce pain, improve function, and correct underlying issues such as poor posture.

What other types of research exist?

Promising, novel alternatives to the Cervigard neck collar for neck pain patients in 2024 may include: 1) Advanced wearable posture correction devices with biofeedback mechanisms, 2) AI-driven physical therapy programs that offer personalized exercise regimens, 3) New pharmacological agents targeting inflammation and pain specific to cervical spine issues, 4) Enhanced spinal manipulation techniques using robotic assistance, and 5) Virtual reality-based psychotherapy for pain management and posture training.

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Cervigard Neck Collar for Neck Pain

N/A

Recruiting

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 and 45 year old (inclusive)

Neck pain ≥ 4 on a 0-10 point numerical rating scale (0 = "no pain", 10 = "maximum pain")

Must not have

Generalized medical disorders that would weaken the vertebrae or other tissue structures within the cervical spine region

History of a tumor in the cervical spine and/or head/neck region within the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from wearing the device, skin irritation under where the collar sits or potential worsening of symptoms if improperly used. However specific side effects haven't been listed as this is an experimental evaluation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

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My neck pain is at least a 4 out of 10.

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I have had neck pain for over 3 months without nerve issues and have seen a doctor.

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My head leans forward compared to my shoulders.

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Standard treatments haven't eased my neck pain.

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My head leans forward compared to my shoulders.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a health condition that weakens my neck bones or tissues.

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I had a tumor in my neck or head area in the last 6 months.

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I currently have a fracture that is new or still healing.

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I have a permanent curve in my spine.

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I have not had an infection in my neck or head area in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Numerical Pain Rating Scale score

Secondary study objectives

Change in Neck Disability Index scores

Change in head position

Change in lordotic angle of the cervical spine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for neck pain, such as posture correction devices and exercises, work by realigning the head and neck to reduce strain on muscles and ligaments. Improving cervical lordosis helps distribute mechanical loads more evenly across the cervical spine, reducing localized stress and pain. These mechanisms are crucial for neck pain patients as they target the root cause of discomfort, potentially offering more sustainable relief compared to treatments that only address symptoms.