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

Kessler Foundation

Status

Enrolling

Conditions

Neck Pain

Treatments

Device: Cervigard Neck Collar

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT05433025

WRNMMC-2021-0347

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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