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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
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 belowSelect...
I am between 18 and 45 years old.
Select...
My neck pain is at least a 4 out of 10.
Select...
I have had neck pain for over 3 months without nerve issues and have seen a doctor.
Select...
My head leans forward compared to my shoulders.
Select...
Standard treatments haven't eased my neck pain.
Select...
My head leans forward compared to my shoulders.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a health condition that weakens my neck bones or tissues.
Select...
I had a tumor in my neck or head area in the last 6 months.
Select...
I currently have a fracture that is new or still healing.
Select...
I have a permanent curve in my spine.
Select...
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
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
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.
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.
Find a Location
Who is running the clinical trial?
Kessler FoundationLead Sponsor
179 Previous Clinical Trials
10,969 Total Patients Enrolled
The Geneva FoundationOTHER
36 Previous Clinical Trials
13,171 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
139 Previous Clinical Trials
33,123 Total Patients Enrolled
1 Trials studying Neck Pain
76 Patients Enrolled for Neck Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 45 years old.I have a health condition that weakens my neck bones or tissues.I had a tumor in my neck or head area in the last 6 months.I currently have a fracture that is new or still healing.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.Standard treatments haven't eased my neck pain.I have a permanent curve in my spine.My neck pain is at least a 4 out of 10.My head leans forward compared to my shoulders.I have not had an infection in my neck or head area in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Waitlist Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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