Safety and Treatment Effect of a Novel Device for Neck Pain in Active-duty Military Personnel With Forward Head Posture.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Numerical Pain Rating Scale score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intervention
Cervigard Neck Collar, which is a device used to treat neck pain caused by forward head posture.
干预措施: Cervigard Neck Collar (Device)
Waitlist Control
This group will receive no intervention for 6 weeks after enrollment. They will receive the device after 6 weeks.
结局指标
主要结局
Change in Numerical Pain Rating Scale score
时间窗: 6 weeks
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."
次要结局
- Change in Neck Disability Index scores(6 weeks)
- Change in head position(6 weeks)
- Change in lordotic angle of the cervical spine(6 weeks)
研究者
Nathan Hogaboom, PhD
Research Scientist
Kessler Foundation