Can a Specific OMT Protocol Influence Patient-reported Pain and Associated Analgesia Use for Primary Headache Disorders?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in analgesia use
研究概览
简要总结
The purpose of this study is to see if osteopathic manipulation or light touch can reduce either or both frequency of headaches or use of pain medication. Osteopathic manipulative treatment (OMT) has been shown to help headache symptoms. The investigators like to see if regular OMT sessions can help reduce headache discomfort and also reduce use of pain medication like over-the-counter medications, migraine medications, and opioids. In this randomized controlled trial, a set sequence of OMT will be compared to light touch sham protocol. Investigators will compare participant responses to questionnaires that assess items including pain levels and reported pain medication use for the course of the study period to see if there are any shifts.
详细描述
The purpose of this study is to evaluate the effectiveness of osteopathic manipulative treatment protocol (OMT) or light touch protocol in reducing headache frequency and the use of pain medication for headache pain. Previous research has suggested that OMT may alleviate headache symptoms. This randomized controlled trial aims to determine whether regular OMT sessions can decrease headache discomfort and reduce the use of pain medications, including over-the-counter medications, migraine-specific treatments, and opioids. The study consists of a ten-week period, including 2 weeks of observation, 6 weeks of intervention, and 2 weeks of washout. Participants will be randomly assigned to either receive OMT or a light touch protocol. Investigators will compare questionnaires assessing quality of life and functionality scales. Pain levels and medication use will be logged daily throughout the study.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years of age
- •takes opioids or any other pain medication for headaches more than 10 times a month (including over the counter and prescription medications for headaches).
- •3 months or greater history of headaches or migraines
- •Patient able to tolerate OMT based on osteopathic physician discretion and with consideration of absolute and relative contraindications to OMT
排除标准
- •current diagnosis of neoplasm
- •history of headache secondary to trauma or concussion
- •history of brain/cranial surgery, cerebral vascular events/disease (e.g., stroke, Brain arteriovenous malformation (AVM), vertebral artery disease)
- •acute psychiatric diagnosis
- •pregnancy
- •history of substance use disorder
结局指标
主要结局
Change in analgesia use
时间窗: Assessment of weekly amount of pain medications used from week 1 till week 10 end of the study period
The primary outcome measures will assess if consistent use of OMT for headache causes a reduction in headache analgesia use for headache-associated discomfort.
Change in pain levels
时间窗: Assessment of weekly average pain from week 1 till week 10 end of the study period
The primary outcome measures will assess if consistent use of OMT for headache causes a reduction in headache pain for headache-associated discomfort. Pain will be rated on a Numeric Rating Scale (NRS) so individuals can rate their pain on a scale from 0 (no pain) to 10 (worst possible pain).
次要结局
- Change in quality of Life - Headache disability index(To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study))
- Change in quality of Life - Headache Impact Test (HIT-6)(To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study))
- Change in quality of Life - The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group (EQ-5DL)(To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study))