Chiropractic Spinal Manipulation for Cervicogenic and Tension-type Headache: a Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pain frequency
研究概览
简要总结
This is a pilot and feasibility randomized controlled trial to assess the efficacy of chiropractic spinal manipulative therapy in patients with tension-type and cervicogenic headache.
详细描述
This study is a pilot and feasibility randomized controlled trial that aims to assess the efficacy of 8 treatment sessions of chiropractic spinal manipulative therapy compared to the same number of sham manipulative therapy or placebo interventions for chronic cervicogenic and tension-type headache. The hypothesis proposed is that chiropractic care will reduce the intensity and frequency of both cervicogenic and tension-type headache episodes, when compared to placebo. A sample of 20 participants suffering from cervicogenic or tension-type headache for at least 3 months, aged 18 to 67 will be randomized to receive either 8 sessions of spinal manipulative treatment (2 times per week for a total of 4 weeks) or 8 sessions of a validated sham spinal manipulation. Outcomes will be assessed at baseline, after 4 treatments and at the end of the treatment period.
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 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 2 episodes per month of cervicogenic or tension-type headache for at least 3 months. Diagnoses will be determined by case history and physical examination according to the International Headache Society criteria (3rd Edition)
排除标准
- •Not fulfilling the inclusion criteria
- •Having received chiropractic treatment in the previous 12 months
- •Diagnosis or frequent symptoms of migraine headaches (symptoms present at least once a month) without an overlapping presentation of cervicogenic or tension-type headache.
- •Patients with pathologies affecting the nervous system (MS, tumors, past history of stroke...)
- •Contraindications to manual therapy, particularly spinal manipulative therapy (cancer, uncontrolled high blood-pressure, severe cardiovascular conditions)
- •Past history of cervical spine surgery
- •Pregnancy
- •Having being diagnosed with a psychiatric conditions, with the exception of depression and anxiety
结局指标
主要结局
Pain frequency
时间窗: 4 weeks
Chronic pain patients will describe whether their pain is episodic (pain-free periods of at least 4 week duration) or fluctuating (no pain-free periods of at least 4 week duration)
Pain intensity
时间窗: 4 weeks
Pain intensity will be measured by showing patients a numerical rating scale from 0 (no pain at all) to 10 (maximum possible pain)
次要结局
- Pain Catastrophizing Scale(4 weeks)
- Pressure pain thresholds(4 weeks)