Intervention for Neck Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Walter Reed National Military Medical Center, Bethesda, MD
Neck Pain
Cervigard Neck Collar - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 6 weeks

6 weeks
Change in Neck Disability Index scores
Change in Numerical Pain Rating Scale score
Change in head position
Change in lordotic angle of the cervical spine

Trial Safety

Trial Design

2 Treatment Groups

Waitlist Control
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention · No Placebo Group · N/A

Intervention
Device
Experimental Group · 1 Intervention: Cervigard Neck Collar · Intervention Types: Device
Waitlist ControlNoIntervention Group · 1 Intervention: Waitlist Control · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks

Trial Background

Nathan Hogaboom, Research Scientist
Principal Investigator
Kessler Foundation
Closest Location: Walter Reed National Military Medical Center · Bethesda, MD
2010First Recorded Clinical Trial
1 TrialsResearching Neck Pain
180 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had neck pain for at least 3 months without neurological signs and have been seen by a provider.
You have neck pain and your pain is not decreasing with conventional treatments.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.