Clinical trial NCT05433025: A Novel Device for Neck Pain in Active-duty Military Personnel With Forward Head Posture.
Official title: Safety and Treatment Effect of a Novel Device for Neck Pain in Active-duty Military Personnel With Forward Head Posture.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: The Geneva Foundation
name: Walter Reed National Military Medical Center
name: Uniformed Services University of the Health Sciences
First posted: 2022-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Numerical Pain Rating Scale score
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Neck Disability Index scores
timeFrame: 6 weeks
measure: Change in lordotic angle of the cervical spine
timeFrame: 6 weeks
measure: Change in head position
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
References: