Comparing the Effect of Osteopathic Manipulative Medicine (OMM) Versus Counseling in the Treatment of Concussion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- SMART Balance Master balance scores pre and post intervention arm
研究概览
简要总结
Concussion or mild traumatic brain injury (TBI) is a challenging injury for physicians to manage and is among the most serious disabling neurological disorders. Physician awareness regarding manifestations of TBI and subsequent treatment are paramount to reduce the burden of disease. Advancements in treatment of mild TBI have been slow with a lack of consensus on treatment methods that show universal success. This gap in treatment choices provides an opportunity for osteopathic manipulative treatment (OMT) to fill. OMT is a hands-on manual therapy that can be integrated to help treat post-concussive symptoms. Previous studies have shown that OMT can help resolve imbalance and tinnitus in elderly populations and case studies have shown that this manual therapy may assist in patient recovery. The investigators hypothesize that OMT will decrease return to play/work time, will show an improvement in balance, and will decrease concussion symptoms as compared to counseling.
详细描述
Purpose:
The purpose of this study is to investigate the effectiveness of osteopathic manipulative treatment (OMT) in improving concussion-related symptoms.
Previous studies and case reports have found a positive effect of OMT on resolving concussion-like symptoms such as vertigo, imbalance, and tinnitus. It is hypothesized that OMT improves proprioceptive input from the cervical spine and joints and sensory input from the internal auditory meatus. The investigators propose to further investigate this relationship in order to quantify the effect of OMT through the SMART Balance Master and return to play/work time. As this is a pilot study, the investigators intend to determine if a correlation exists between OMT and return to work/play and SMART Balance Master scores.
Specifically, the investigators have three main aims for this study:
Specific Aim #1: OMT will show a statistically significant improvement balance as measured by the SMART Balance Master scores pre- and post-OMT
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years age
- •Subject has suffered from non-life threatening head trauma head trauma resulting in current concussion-related symptoms
- •Subject is evaluated and diagnosed with a concussion
- •Subject has been cleared to participate in the study by the physician/neurologist having excluded any potential emergent conditions
排除标准
- •The subject has no absolute contraindications to osteopathic manipulative treatment, such as skull fracture, cervical fracture, signs of intracranial bleeding, cervical dissection, or stroke
- •The subject suffered from any of the following at the time of event leading to concussion:
- •Loss of consciousness >2 minutes in the field
- •Intractable vomiting
- •Paralysis
- •The subject has been diagnosed with an underlying neurodegenerative condition that may confound test results (e.g.. Parkinson's Disease, Alzheimer's Disease)
- •The subject has a current or previous spinal cord injury
- •The subject is unable to complete the assessment tools
- •The subject is pregnant
结局指标
主要结局
SMART Balance Master balance scores pre and post intervention arm
时间窗: change from the pre-intervention score after the intervention, measured at each visit through study completion, an average of 1 week after the initial visit
OMT should show a statistically significant improvement in balance as measured by SMART Balance Master balance scores as measured by change pre and post procedure
次要结局
- Post-concussion symptoms as measured by SCAT-3(measured on day 1, day 3, and day 7 post concussion)
- Post-concussion symptoms as measured by King-Devick(measured on day 1, day 3, and day 7 post concussion)
- Post-concussion symptoms as measured by ImPACT(measured on day 1, day 3, and day 7 post concussion)
研究者
Sheldon Yao
Associate Profession, Chair of the Department of Osteopathic Manipulative Medicine
New York Institute of Technology