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| Name | Class |
|---|---|
| The Geneva Foundation | OTHER |
| Walter Reed National Military Medical Center | FED |
| Uniformed Services University of the Health Sciences | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Cervigard Neck Collar, which is a device used to treat neck pain caused by forward head posture. |
|
| Waitlist Control | No Intervention | This group will receive no intervention for 6 weeks after enrollment. They will receive the device after 6 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervigard Neck Collar | Device | A device used to treat neck pain caused by forward head posture |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2023 | Jul 23, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| 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 |