Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy in the Perception of Pain and Cervical Motion: a Double-blind, Randomized, Placebo-controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- An individual clinical interview was conducted to collect socio-demographic data and characteristics of headache in a one-month base period (the previous 4 weeks)
研究概览
简要总结
Background. Tension-type headache (TTH) is the most common form of primary headache and it is a real problem for the subjects suffering from it. Until now, physiotherapy treatments have included different techniques combined together, without establishing which of them is more effective.
Objective. The purpose of this study is to know the effectiveness of manipulative and manual therapy treatments, with regard to pain perception and neck mobility in patients with tension-type headache.
Methods: A double-blind, randomized clinical trial was conducted, with 84 patients diagnosed with tension-type headache, divided into three treatment groups -manual therapy, manipulative therapy, and a combination of both techniques-, and a placebo control group. Four treatment sessions were administered during four weeks, with post-treatment assessment, and follow-up at one month. Cervical ranges of motion were assessed (CROM device), as well as pain perception (McGill Pain Questionnaire), and frequency and intensity of headaches (weekly register).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Subjects aged between 18 and 65 years
- •Diagnosis of frequent ETTH and CTTH
- •Having headache episodes on more than 1 day per month
- •Headache episodes lasting from 30 minutes to 7 days
- •Headaches having at least 2 of the following characteristics:
- •Bilateral location of pain
- •Pressing non pulsating quality
- •Mild or moderate intensity
- •Not aggravated by physical activity
- •Sufferers may present photophobia, phonophobia, nausea or vomiting
- •Headache may be associated with pericranial tenderness
- •Suffering from TTH for over 3 months
- •Subjects being under pharmacological control
排除标准
- •Patients with infrequent ETTH, and patients with probable TTH in its frequent and infrequent forms.
- •Headache that is aggravated by head movements.
- •Metabolic or musculoskeletal disorders with symptoms similar to headache
- •Previous neck trauma
- •Vertigo, dizziness, arterial hypertension.
- •Joint stiffness, arteriosclerosis or advanced degenerative osteoarthritis
- •Patients with heart devices
- •Patients in process of pharmacological adaptation
- •Excessive emotional tension
- •Neurological disorders
- •Laxity of neck soft tissues
- •Radiological alterations
- •General hypermobility or hyperlaxity
- •Joint instability
- •Pregnancy
结局指标
主要结局
An individual clinical interview was conducted to collect socio-demographic data and characteristics of headache in a one-month base period (the previous 4 weeks)
时间窗: up to 4 weeks
Firstly, socio-demographic data and characteristics of headache were collected during the four weeks prior to the treatment through individual clinical interview carried out by a physiotherapist who did not participate in the outcome assessment nor in the administration of treatments. It included age and sex, location of pain, side dominance of pain, type of pressure, connection with physical activity, frequency, severity of pain, associated symptoms and pain intensity, rated by the patient on the 0-10 Visual Analogue Scale (VAS) (0 = no pain, 10 = most severe pain).
次要结局
- Multidimensional perception of pain, assessed by the McGill Pain Questionnaire(up to 8 weeks)
- Cervical ranges of motion, measured with the CROM-device(up to 8 weeks)
- Weekly register(up to 7 weeks)
研究者
GEMMA V ESPÍ LÓPEZ, PhD
PhD, PT
University of Valencia