A Novel Device for Neck Pain in Active-duty Military Personnel With Forward Head Posture.

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    40
  • sponsor
    Kessler Foundation
Updated on 10 July 2022
discomfort
manipulation

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, 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.

Details
Condition Neck Pain
Treatment Cervigard Neck Collar
Clinical Study IdentifierNCT05433025
SponsorKessler Foundation
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

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
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