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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05433025
• Other study ID #: WRNMMC-2021-0347
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Kessler Foundation
• Contact: Nathan Hogaboom, PhD
• Phone: 9733243584
• Email: nhogaboom[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

Device:
• Cervigard Neck Collar
A device used to treat neck pain caused by forward head posture

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Kessler Foundation	The Geneva Foundation, Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Neck Disability Index scores	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.	6 weeks
Secondary	Change in lordotic angle of the cervical spine	The angle of the curve of the cervical spine will be measured using a custom computer program in blinded and random fashion.	6 weeks
Secondary	Change in head position	The position of the cranium relative to the 7th cervical vertebra will be measured using a custom computer program in blinded and random fashion.	6 weeks