SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Headache Impact Test (HIT-6)
研究概览
简要总结
This is a prospective randomized controlled trial comparing two different physical therapy approaches to the treatment of posttraumatic headache with autonomic symptoms. AIM 1: To establish the efficacy of SPINEPASS against Standard Physical Therapy to reduce headache disability and impact amongst patients with persistent post-concussion headache. AIM 2: Demonstrate the superiority of SPINEPASS in the efficient self-management of headache. Demonstrate its appropriateness, acceptability, and feasibility and gain patient insights among patients with PPTH compared to standard PT.
详细描述
Persistent post traumatic headache (PPTH) is a significant problem for the US military affecting up to 33% of service members with a history of mild traumatic brain injury (mTBI) and treatment is usually ineffective. The persistent and chronic nature of PPTH leads to significant disability, burden and reduced readiness. It is commonly migraine-like and associated with visual complaints, and transient neurological abnormalities that can be classified as autonomic nervous system (ANS) in nature. Due to the forces involved during concussion, injury to the brain and neck likely co-occur. Recent research suggests that upper cervical hypermobility may trigger an ANS response and be related to these headaches, due to close anatomical connections to the ANS and dura. Specifically, the dura has unique upper cervical myodural connections to help protect the spinal cord during head movements, with attachments throughout the entire spine. It is innervated by the ANS, is pain sensitive and can cause headache.
The investigators developed a rehabilitation approach to effectively address headache and ANS symptoms in patients. The treatment is hypothesized to influence dura mater and ANS function by addressing the consequences of upper cervical hypermobility. The treatment is a pragmatic biomechanical approach individualized to patients' specific impairments. The approach to this treatment is named SPINE self-management techniques for Persistent headache After concuSSion (SPINEPASS), and it pairs specific personal physical therapy (PT) targets with treatment ingredients.
In this study the investigators plan to conduct a randomized controlled trial (RCT), with a community-based participatory research approach, to explore the efficacy of the SPINEPASS approach on headache disability and self-confidence to manage headache without abortive medication, compared to standard physical therapy (PT) for persistent symptoms post-mTBI. Standard PT will specifically address the neck and the vestibular and oculomotor systems as well as prescribing graded exercise and or relaxation training for management of ANS dysfunction. It does not address the dura mater and while it will aim to stabilize the upper cervical spine, it does not consider the precise restoration of balance of the upper cervical muscles or consider the role of the dura mater to protect and maintain patency of the spinal cord and brain. The investigators will also explore patient experiences and acceptability and feasibility of the program. The hypothesis is that overall, patients will have unique insights and will rate SPINEPASS more appropriate, acceptable and feasible.
Concurrently, the study will include a qualitative arm interviewing participants post-treatment to incorporate an understanding of participants' perspectives on the program to enable effective and sustainable translation of the program into clinical practice. It will consider whether individual confidence for self-management of PPTH is improved in the short and intermediate term and consider participants' perspectives on feasibility, acceptability, and appropriateness of the program as well as factors contributing to the success or failure of these treatment approaches.
Objectives/Specific Aims/Hypotheses:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent Post-traumatic headache (PPTH) duration =or > 4 weeks.
- •No self-reported improvement in headache pattern in the past 3 weeks. (Patients will be asked to determine whether the usual pattern of their headaches has changed for the better over the last 3 weeks.
- •Compass-31 score > 21 to select patients who have evidence of ANS dysfunction which SPINEPASS aims to address.
- •Headache Impact Test (HIT6) =>50 to capture headache-related disability of "some impact" or more.
- •Headache worst intensity >3/10 on a numerical rating scale (NRS), at least once per week.
排除标准
- •Contraindications for spinal or graded general exercise.
- •Contraindications to spinal manual therapy at or below C5-6 level
- •Cognitive impairment/ language barriers affecting ability to participate.
- •Redeployment/relocation or retirement planned within the next 6 months to reduce the chances of dropouts to treatment and follow-up.
- •Rating self-confidence to manage (eliminate and or lower) headaches without abortive medication at baseline of 30% or greater.
- •Inability to attend up to 12 in-person treatment sessions for 4 months.
- •Unwilling to limit commencement of other management for PPTH during the trial period.
- •Botox for headache management within the last 8 weeks or during the trial.
结局指标
主要结局
Headache Impact Test (HIT-6)
时间窗: Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)
The HIT-6 is a validated measure of disability associated with headache and has been shown to be useful in migraine. A higher score indicates greater disability. Scores between 50 and 55 represent some impact; scores between 56 and 59 represent substantial impact, and scores \> 60 indicate severe impact. A reduction in the score of six or more is considered a clinically meaningful change.
Confidence to self-manage headache
时间窗: Baseline; T1 (treatment completion- up to 12 weeks); T2 (3 months post T1)
An electronic diary will ask the patients to rate their perceived ability to self-manage (a) lower and b) eliminate their headache using the exercises or tools, (without abortive medication measures), each week using a % scale, where 100% indicates the patient can manage it perfectly and 0% indicates an inability to manage the headache. This score is based on measures of global perceived effect or rating scales but modified to be captured in a percentage score.
次要结局
- Neurobehavioral Symptom Inventory (NSI).(Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1))
- Composite Autonomic Symptom Score (COMPASS-31)(Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1))
研究者
Dr Lucy Thomas
Principal Investigator
The University of Queensland