A Pragmatic Randomised Controlled Trial on the Effectiveness of Manual Therapy as an Adjunct to Tertiary Management in Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in migraine-related disability
研究概览
简要总结
The aim of this study is to determine if adding manual therapy to care as usual reduces the discomfort from chronic migraine compared to care as usual alone
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adults 18 years of age or older with a good command of English (to enable informed consent) Existing patients with chronic migraine as diagnosed by a clinical interview with a neurologist in line with the International Classification of Headache Diagnosis criteria (ICHD) Undergoing care as usual from the neurologist
排除标准
- •Currently having or had manual therapy for neck, shoulder in the last six weeks.
- •Having a condition contraindicated for manual therapy including but not limited to inflammatory disorders, severe osteoporosis and tumours.
- •Identification of any medical 'red flags' by the neurologist including
- •Evidence of any central nervous system involvement for example:
- •Facial palsy (presence of ptosis/Horner's syndrome)
- •Visual disturbance (presence of blurred vision, diplopia, hemianopia)
- •Speech disturbance (presence of dysarthria, dysphonia, dysphasia such as expressive or receptive)
- •Balance disturbance (presence of dizziness, imbalance, unsteadiness, falls)
- •Paraesthesia (presence, location such as upper limb/lower limb, face)
- •Weakness (presence, location such as upper limb/lower limb)
- •Known major psychiatric or psychological conditions not under control
研究组 & 干预措施
Care as usual plus manual therapy
Other
干预措施: Care as usual (Drug)
Care as usual
This is the care provided by the neurologist for chronic migraine.
干预措施: Care as usual (Drug)
Care as usual plus manual therapy
Other
干预措施: Manual Therapy (Other)
结局指标
主要结局
Change in migraine-related disability
时间窗: 12 weeks
Headache Impact Test (HIT6). The six-item Headache Impact Test (HIT-6) provides a global measure of adverse headache impact and is used in screening and monitoring patients. The HIT-6 items measure the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning, psychological distress and the severity of headache pain. The final HIT-6 score is obtained from simple summation of the six items and ranges between 36 and 78, with larger scores reflecting greater impact. The categories used for interpretation of impact are: little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78).
次要结局
- Change in Migraine Specific Quality of Life Questionnaire Score (MSQoL 2.1)(12 weeks)
- Headache Frequency(12 weeks)