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NCT Number: NCT05433025

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Cervigard Neck Collar

Device

A device used to treat neck pain caused by forward head posture

Primary outcomes

  1. 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."

Secondary outcomes

  1. Change in Neck Disability Index scores

    Time frame: 6 weeks

    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.

  2. Change in lordotic angle of the cervical spine

    Time frame: 6 weeks

    The angle of the curve of the cervical spine will be measured using a custom computer program in blinded and random fashion.

  3. Change in head position

    Time frame: 6 weeks

    The position of the cranium relative to the 7th cervical vertebra will be measured using a custom computer program in blinded and random fashion.

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • The Geneva Foundation
  • Uniformed Services University of the Health Sciences
  • Walter Reed National Military Medical Center

Registry information

Official study title

Safety and Treatment Effect of a Novel Device for Neck Pain in Active-duty Military Personnel With Forward Head Posture.

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 27, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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