Kessler Foundation Studies Efficacy of Cervigard
Kessler Foundation received a $223,000 award from The Geneva Foundation for a two-year study investigating the safety and efficacy of the Cervigard Forward Head Posture (FHP) Neck Collar in active duty personnel. This funding builds upon the Foundation’s participation as one of the civilian sites involved with the Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) program, headquartered at the Uniformed Services University (USU) in Bethesda, Maryland.
Non-battle injuries are the most common cause of service-member attrition. In recent operations (e.g. Operation Iraqi Freedom, Operation Enduring Freedom, Operation Desert Storm), musculoskeletal complaints were the most common reason for hospitalization and medical evacuation, and such complaints represented up to one-third of all injuries. Among the broad spectrum of these musculoskeletal injuries, spinal injuries comprised nearly twenty-five percent.
Causes of nonspecific neck pain are generally multifactorial with any number of etiologies, however mechanical factors are generally part of the problem. One such factor is forward head posture (FHP), which has been found to be highly associated with neck pain as it can place unnecessary strain on the soft tissues of the cervical spine and cause a loss of the normal lordodic curve. A reduction of cervical lordosis can lead to degenerative changes that are largely irreversible if not treated properly, as well as many other potential consequences, including migraines, neck pain and dysfunction. Forward head posture may also have a greater impact on neck pain in younger individuals (less than 50 years old) than older individuals.
Testing the efficacy of a simple, wearable device for the treatment of neck pain is highly relevant to the military. Current treatments for spinal pain in military personnel are generally drawn from the civilian population and tend to be multimodal, relying upon physical therapy, pharmacological agents, spinal manipulation, and psychotherapy. However, there are drawbacks to some of these treatment modalities. Opioids and other pharmacological agents may not only lead to addiction and accidental overdose, but can elicit cognitive detriments that may lead to adverse consequences (i.e., motor vehicle collisions and balance and memory impairments). Physical therapy is well-studied in the civilian population, yet may not generalize to the active-duty population due to environmental and occupational differences. In addition, there does not exist a wide body of evidence to support many of these treatments in active-duty military.
Developed by Ron Dellanno, MD, the Cervigard FHP Neck Collar was created for patients with severe neck pain due to forward head posture and serves as a promising treatment option for military personnel. The device accomplishes FHP correction by applying a three-point pressure system, allowing the cranium to translate posteriorly over the shoulders without compromising the cervical lordotic curve. A preliminary 6-week intervention among civilians who presented with neck pain showed reduced pain, improved lordodic curve, and reduced forward head posture. This technology has yet to be tested in the non-civilian population and could potentially improve treatment outcomes for active duty personnel. The present study targets neck pain, which is highly common amongst active-duty servicemen and women, particularly combat medics. Such an injury can have a host of negative downstream effects that impact the soldier him- or herself, including poorer quality of life, reduced function, and greater pain for an extensive period of time.
The single-blind, randomized waitlist-controlled study involves random assignment to either an immediate treatment group or a 6-week waitlist group. Participants will be required to wear the Cervigard neck collar for 20 minutes per day for 6 weeks, with patient reported outcomes and X-ray imaging conducted at baseline and follow-up assessments in order to evaluate the efficacy of the treatment.
Gerard Malanga, MD, director of Kessler Institute for Rehabilitation’s Regenerative Medicine Program and director of New Jersey Regenerative Institute, serves as the project’s principal investigator. Co-investigators are Trevor Dyson-Hudson, MD, director of Kessler Foundation’s Center for Spinal Cord Injury Research, Nathan Hogaboom, PhD, from the Center’s Regenerative Rehabilitation Research Laboratory, Nelson Hager, MS, MD, Vice Chair of USU’s Department of Physical Medicine and Rehabilitation and Director of MIRROR, and COL Matthew St Laurent, MD, Chief of Occupational Therapy at Walter Reed National Military Medical Center.
The opinions and assertions expressed herein are those of the author(s) and do not necessarily reflect the official policy or position of the Uniformed Services University or the Department of Defense.
About The Geneva Foundation
The Geneva Foundation is a 501(c)3 non-profit organization that advances military medicine through innovative scientific research, exceptional program management, and a dedication to U.S. service members and veterans, their families, and the global community. Geneva is proud to have over 25 years of experience in delivering full spectrum scientific, technical, and program management expertise in the areas of federal grants, federal contracts, industry sponsored clinical trials, and educational services. genevaUSA.org
Non-battle injuries are the most common cause of service-member attrition. In recent operations (e.g. Operation Iraqi Freedom, Operation Enduring Freedom, Operation Desert Storm), musculoskeletal complaints were the most common reason for hospitalization and medical evacuation, and such complaints represented up to one-third of all injuries. Among the broad spectrum of these musculoskeletal injuries, spinal injuries comprised nearly twenty-five percent.
Causes of nonspecific neck pain are generally multifactorial with any number of etiologies, however mechanical factors are generally part of the problem. One such factor is forward head posture (FHP), which has been found to be highly associated with neck pain as it can place unnecessary strain on the soft tissues of the cervical spine and cause a loss of the normal lordodic curve. A reduction of cervical lordosis can lead to degenerative changes that are largely irreversible if not treated properly, as well as many other potential consequences, including migraines, neck pain and dysfunction. Forward head posture may also have a greater impact on neck pain in younger individuals (less than 50 years old) than older individuals.
Testing the efficacy of a simple, wearable device for the treatment of neck pain is highly relevant to the military. Current treatments for spinal pain in military personnel are generally drawn from the civilian population and tend to be multimodal, relying upon physical therapy, pharmacological agents, spinal manipulation, and psychotherapy. However, there are drawbacks to some of these treatment modalities. Opioids and other pharmacological agents may not only lead to addiction and accidental overdose, but can elicit cognitive detriments that may lead to adverse consequences (i.e., motor vehicle collisions and balance and memory impairments). Physical therapy is well-studied in the civilian population, yet may not generalize to the active-duty population due to environmental and occupational differences. In addition, there does not exist a wide body of evidence to support many of these treatments in active-duty military.
Developed by Ron Dellanno, MD, the Cervigard FHP Neck Collar was created for patients with severe neck pain due to forward head posture and serves as a promising treatment option for military personnel. The device accomplishes FHP correction by applying a three-point pressure system, allowing the cranium to translate posteriorly over the shoulders without compromising the cervical lordotic curve. A preliminary 6-week intervention among civilians who presented with neck pain showed reduced pain, improved lordodic curve, and reduced forward head posture. This technology has yet to be tested in the non-civilian population and could potentially improve treatment outcomes for active duty personnel. The present study targets neck pain, which is highly common amongst active-duty servicemen and women, particularly combat medics. Such an injury can have a host of negative downstream effects that impact the soldier him- or herself, including poorer quality of life, reduced function, and greater pain for an extensive period of time.
The single-blind, randomized waitlist-controlled study involves random assignment to either an immediate treatment group or a 6-week waitlist group. Participants will be required to wear the Cervigard neck collar for 20 minutes per day for 6 weeks, with patient reported outcomes and X-ray imaging conducted at baseline and follow-up assessments in order to evaluate the efficacy of the treatment.
Gerard Malanga, MD, director of Kessler Institute for Rehabilitation’s Regenerative Medicine Program and director of New Jersey Regenerative Institute, serves as the project’s principal investigator. Co-investigators are Trevor Dyson-Hudson, MD, director of Kessler Foundation’s Center for Spinal Cord Injury Research, Nathan Hogaboom, PhD, from the Center’s Regenerative Rehabilitation Research Laboratory, Nelson Hager, MS, MD, Vice Chair of USU’s Department of Physical Medicine and Rehabilitation and Director of MIRROR, and COL Matthew St Laurent, MD, Chief of Occupational Therapy at Walter Reed National Military Medical Center.
The opinions and assertions expressed herein are those of the author(s) and do not necessarily reflect the official policy or position of the Uniformed Services University or the Department of Defense.
About The Geneva Foundation
The Geneva Foundation is a 501(c)3 non-profit organization that advances military medicine through innovative scientific research, exceptional program management, and a dedication to U.S. service members and veterans, their families, and the global community. Geneva is proud to have over 25 years of experience in delivering full spectrum scientific, technical, and program management expertise in the areas of federal grants, federal contracts, industry sponsored clinical trials, and educational services. genevaUSA.org