The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit.
研究概览
简要总结
Pilot study looking at the Osteopathic Manipulative Treatment (OMT) for various headache types in patients with post-concussion syndrome (PCS). Twenty-six subjects with symptoms lasting >3 months were enrolled and were randomly assigned to a treatment group (n = 13) and a control group (n = 13).
详细描述
Evidence shows the effectiveness of Osteopathic Manipulative Treatment (OMT) for various headache types, with limited evidence of its use for headaches related to mild traumatic brain injury (MTBI). No studies were found regarding OMT for headaches in patients with post-concussion syndrome (PCS), defined as symptom persistence >3 months after MTBI.
Objective
To evaluate OMT for headaches in patients with PCS. Methods: A controlled pilot study was conducted of patients with PCS who presented to an outpatient interdisciplinary rehabilitation clinic. Twenty-six subjects with symptoms lasting >3 months were enrolled and were randomly assigned to a treatment group (n = 13) and a control group (n = 13). Primary outcome measures were 1) immediate change in headache scores with a visual analog scale (VAS) and 2) change in the 6-item Headache Impact Test (HIT-6) between baseline and follow-up visits. 10 control participants completed HIT-6 between baseline and follow-up visits but did not receive OMT and did not complete VAS. After OMT, immediate VAS changes in treatment group and the improvements in HIT-6 scores for both groups between baseline and follow-up were analyzed for statistical significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of mild traumatic brain injury (MTBI),
- •age 18 years or older
- •injury occurring >3 months prior, and
- •headache as a primary symptomatic concern.
排除标准
- •history of moderate to severe traumatic brain injury (TBI),
- •documented intracranial injury,
- •chronic headache or migraine headache before the injury,
- •treatment with a headache specialist at the time of injury, or receipt of IV infusion for medication for headache at the time of treatment.
结局指标
主要结局
Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit.
时间窗: 4 weeks post treatment (Follow-up visit 1)
HIT-6 was completed at baseline and competed to HIT-6 completed post treatment at follow up visit. Headache Impact Test (HIT-6) is a measure of headache severity and provides information regarding the effect of headache on other domains related to functional participation. The HIT-6 has six questions and the range goes from 36 (best outcome) to a maximum score of 78 (worst outcome). Higher HIT-6 scores indicate increased headache severity and greater functional limitations.
Immediate Change in Headache Scores With a Visual Analog Scale (VAS)
时间窗: Same day with treatment on visit 1
Change in the headache scores, defined as the different pain pre and post treatment using the visual analog scale (VAS). VAS is widely used to capture pain, the scale ranges from 0-10 with 0 (best outcome) being no pain and 10 being the worst pain possible (worst outcome).
次要结局
未报告次要终点