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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Cervigard Neck Collar, which is a device used to treat neck pain caused by forward head posture.

Group Type EXPERIMENTAL

Cervigard Neck Collar

Intervention Type DEVICE

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

Waitlist Control

This group will receive no intervention for 6 weeks after enrollment. They will receive the device after 6 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cervigard Neck Collar

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No