Neck PainNCT05433025
A Novel Device for Neck Pain in Active-duty Military Personnel With Forward Head Posture.
A study testing Cervigard Neck Collar in people with Neck Pain, run by Kessler Foundation at 1 site in United States.
Trial summary
Neck pain is a common complaint among active duty military personnel, and can have tremendous impacts on quality of life and participation in duty-related activities. Treatments for spinal pain in military personnel are typically multimodal, relying upon physical therapy, pharmacological agents, spinal manipulation… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Cervigard Neck Collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DEERS Eligible
- Age 18 and 45 year old (inclusive)
- Neck pain duration ≥ 3 months without neurological signs and have been seen by a provider.
- Conventional treatments have not decreased neck pain
- Neck pain ≥ 4 on a 0-10 point numerical rating scale (0 = "no pain", 10 = "maximum pain")
- Forward head posture, indicated by forward placement of the head relative to the shoulders.
Who cannot join
- History of a tumor in the cervical spine and/or head/neck region within the past 6 months.
- Infection involving the cervical spine and/or head/neck region within the past 6 months.
- Generalized medical disorders that would weaken the vertebrae or other tissue structures within the cervical spine region.
- Fracture that is acute and/or still healing
- Spinal deformities (e.g. Fixed kyphosis, Ankylosing spondylosis)
- Medical and/or psychological condition that would preclude safe participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Safety and Treatment Effect of a Novel Device for Neck Pain in Active-duty Military Personnel With Forward Head Posture.
Neck pain is a common complaint among active duty military personnel, and can have tremendous impacts on quality of life and participation in duty-related activities. Treatments for spinal pain in military personnel are typically multimodal, relying upon physical therapy, pharmacological agents, spinal manipulation, and psychotherapy. However, there does not exist a wide body of evidence to support many of these treatments 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 yet to be tested experimentally. The objective of this study is to evaluate the treatment effect and safety of a novel device for the treatment of neck pain using self-reported pain and function measures, as well as objective radiological measures of cervical lordosis and head posture. Participants will be randomized to be fitted with and receive the Cervigard neck collar either immediately, or 6-weeks after being screened. Participants will complete neck pain and function questionnaires, and have cervical X-Rays collected at screening, treatment, 6 weeks, and 12 weeks (for the immediate group). Participants will be instructed to wear the collar every day for the duration of the trial. Self-reported neck pain and function measures will be collected, as well as cervical X-Rays, protocol adherence measures, and adverse events. The intervention is expected to reduce neck pain/discomfort, improve function, and improve cervical lordosis.
- Conditions
- Neck Pain
- Being tested
- Cervigard Neck Collar
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervigard Neck CollarDevice
A device used to treat neck pain caused by forward head posture
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Cervigard Neck Collar, which is a device used to treat neck pain caused by forward head posture. Receives: Device: Cervigard Neck Collar |
| Waitlist Control | No intervention | This group will receive no intervention for 6 weeks after enrollment. They will receive the device after 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numerical Pain Rating Scale score
Neck pain intensity will be assessed using the Numerical Rating Scale. Subjects will be asked to rate their average pain during the past week using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "worst pain ever experienced."
Measured: 6 weeks
Secondary outcomes (3)
Change in Neck Disability Index scores
The Neck Disability Index is a disease-specific measure of neck pain-related sequelae. It includes 10 sections designed to capture different aspects of everyday life and how neck pain potentially affects those areas. Examples include personal care, lifting, headaches, concentration, work, and sleep.
Measured: 6 weeks
Change in lordotic angle of the cervical spine
The angle of the curve of the cervical spine will be measured using a custom computer program in blinded and random fashion.
Measured: 6 weeks
Change in head position
The position of the cranium relative to the 7th cervical vertebra will be measured using a custom computer program in blinded and random fashion.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start20 Jun 2022
- Primary completion30 Mar 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- The Geneva Foundation, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences
- Responsible party
- Principal investigator, Nathan Hogaboom, PhD, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433025
- Sponsor's protocol ID
- WRNMMC-2021-0347
- Status last verified
- Oct 2026
- First submitted
- 23 Jun 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Treatment Effect of a Novel Device for Neck Pain in Active-duty Military Personnel With Forward Head Posture.
- ClinicalTrials.gov ID
- NCT05433025
- Acronym / sponsor ID
- WRNMMC-2021-0347
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- The Geneva Foundation, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neck pain is a common complaint among active duty military personnel, and can have tremendous impacts on quality of life and participation in duty-related activities. Treatments for spinal pain in military personnel are typically multimodal, relying upon physical therapy, pharmacological agents, spinal manipulation, and psychotherapy. However, there does not exist a wide body of evidence to support many of these treatments 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 yet to be tested experimentally. The objective of this study is to evaluate the treatment effect and safety of a novel device for the treatment of neck pain using self-reported pain and function measures, as well as objective radiological measures of cervical lordosis and head posture. Participants will be randomized to be fitted with and receive the Cervigard neck collar either immediately, or 6-weeks after being screened. Participants will complete neck pain and function questionnaires, and have cervical X-Rays collected at screening, treatment, 6 weeks, and 12 weeks (for the immediate group). Participants will be instructed to wear the collar every day for the duration of the trial. Self-reported neck pain and function measures will be collected, as well as cervical X-Rays, protocol adherence measures, and adverse events. The intervention is expected to reduce neck pain/discomfort, improve function, and improve cervical lordosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Cervigard Neck CollarCervigard Neck Collar, which is a device used to treat neck pain caused by forward head posture. |
| Waitlist Control | No intervention | –This group will receive no intervention for 6 weeks after enrollment. They will receive the device after 6 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- DEERS Eligible
- Age 18 and 45 year old (inclusive)
- Neck pain duration ≥ 3 months without neurological signs and have been seen by a provider.
- Conventional treatments have not decreased neck pain
- Neck pain ≥ 4 on a 0-10 point numerical rating scale (0 = "no pain", 10 = "maximum pain")
Key exclusion criteria (6 listed)
- History of a tumor in the cervical spine and/or head/neck region within the past 6 months.
- Infection involving the cervical spine and/or head/neck region within the past 6 months.
- Generalized medical disorders that would weaken the vertebrae or other tissue structures within the cervical spine region.
- Fracture that is acute and/or still healing
- Spinal deformities (e.g. Fixed kyphosis, Ankylosing spondylosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervigard Neck CollarA device used to treat neck pain caused by forward head posture | Device | Intervention |
Primary outcome
Change in Numerical Pain Rating Scale score
Time frame: 6 weeks
Neck pain intensity will be assessed using the Numerical Rating Scale. Subjects will be asked to rate their average pain during the past week using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "worst pain ever experienced."
3 secondary outcomes
Change in Neck Disability Index scores
Time frame: 6 weeks
Change in lordotic angle of the cervical spine
Time frame: 6 weeks
Change in head position
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervigard Neck Collar in people with Neck Pain, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numerical Pain Rating Scale score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.