Treatment of Tension-type Headache With Articulatory and Suboccipital Soft Tissue Therapy: 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
- Firstly, 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. Headache is one of the most common causes of consultation in primary health care and neurology in Europe. Cervical muscle tension can maintain a restriction of joint motion at the suboccipital level, facilitating the referred head pain.
Objective. To evaluate the effectiveness of two manual therapy treatments for tension-type headache.
Methods. A randomized double-blind clinical trial was conducted, for a period of 4 weeks and a follow-up at one month post-treatment. Eighty-four patients with tension-type headache were assigned to 4 groups (3 treatment groups and 1 control group). Treatments included manual therapy of suboccipital soft tissue inhibition, occiput-atlas-axis global manipulation, and a combination of both techniques. Outcome measures were: impact of headache, disability caused by headache, ranges of motion of the craniocervical junction, frequency and intensity of headache, and associated headache symptoms.
Results. After 8 weeks, there were significant improvements in impact of headache (p=0.01), disability (p=0.001), and craniocervical flexion (p=0.03) for the suboccipital soft tissue inhibition group; in headache impact and disability (p=0.000), pain intensity (p=0.02) and craniocervical flexion (p=0.004) and extension (p=0.04) for the occiput-atlas-axis group; and in impact (p=0.002), functional disability (p=0.000), headache frequency (p=0.002) and intensity (p=0.001), craniocervical flexion (p=0.008) and extension (p=0.003) and associated headache symptoms (p=0.01) for the combined therapy group, with effect sizes from medium to large.
Conclusions. Occiput-atlas-axis and combined therapy group treatments are more effective than suboccipital soft tissue inhibition for tension-type headache. The treatment with suboccipital soft tissue inhibition, despite producing less significant results, also has positive effects on different aspects of headache.
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
- •Age between 18 and 65 years, episodes of headaches lasting from 30 minutes to 7 days, headache having at least two of the following characteristics: *bilateral location
- •pressing non-pulsating quality
- •mild or moderate intensity
- •not aggravated by routine physical activity.
- •Participants may present photophobia or phonophobia, nausea or vomiting, pericranial tenderness, with evolution of more than three months, and they must be under pharmacological control.
排除标准
- •Patients with other types of headache
- •Headache that is aggravated by head movements
- •Metabolic disorders or musculoskeletal complaints previous neck trauma
- •Dizziness
- •Arterial hypertension
- •Advanced degenerative osteoarthritis
- •Neck joint stiffness
- •Signs of malignancy
- •Pregnancy
- •Patients with cardiac devices
- •Patients in process of pharmacological adaptation, and excessive emotional tension
结局指标
主要结局
Firstly, 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
This interview gathers information about age, sex, intensity and frequency of headache (with a Visual Analog Scale from 0 to 10), severity of pain (low, moderate, high), qualities of pain (Bilateral location of pain, Pulsating pressure, Not aggravated by physical activity, Photofobia/Phonofobia, Nausea/Vomiting, Pericranial tenderness), cranial location of pain, family history of headache, triggers, aggravating and pain-relieving factors, as well as any previous physiotherapy treatment for headache relief.
次要结局
- Impact of headache on daily life(HIT-6)(up to 8 weeks)
- Headache Disability Inventory (HDI)(up to 8 weeks)
- Headache pain intensity(up to 8 weeks)
- Ranges of motion of the craniocervical junction(up to 8 weeks)
- Headache diary(up to 8 weeks)
研究者
GEMMA V ESPÍ LÓPEZ, PhD
PhD, PT
University of Valencia