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

NCT05433025 | Active Not Recruiting FDA Device

• 1 other identifier: WRNMMC-2021-0347
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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."

  6 weeks

Secondary Outcomes (3)

• Change in Neck Disability Index scores

  6 weeks

• Change in lordotic angle of the cervical spine

  6 weeks

• Change in head position

  6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

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.

Interventions

Cervigard Neck Collar DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 27, 2022
• Study Start: June 20, 2022
• Primary Completion: March 30, 2025
• Study Completion: April 30, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)