Efficacy of Mindfulness Therapy in Orofacial Chronic Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- orofacial pain intensity
研究概览
简要总结
Psychological impairments have a significant role in management and coping of pain in patients with orofacial pain disorders. The response of this kind of pathologies to topical or systemic medications is not predictable and mindfulness breathing and relaxation techniques could present good results since it help patients to accept their problem and to cope it. In consequence, the present study is aimed to evaluate the efficacy of a mindfulness therapy program in management of chronic orofacial pain.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed of orofacial chronic pain by a physician.
排除标准
- •Pain with oncologic origin
- •Severe mental disorder
结局指标
主要结局
orofacial pain intensity
时间窗: 5 months
mean of orofacial pain in the last seven daysevaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain
Symptoms of temporomandibular disorders
时间窗: 5 months
Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
Dizziness-related disability
时间窗: 5 months
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Catastrophization of pain
时间窗: 5 months
Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
Kinesiophobia
时间窗: 5 months
Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
Sleep quality
时间窗: 5 months
Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
Neck pain-related disability
时间窗: 5 months
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Impact of headache
时间窗: 5 months
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
次要结局
未报告次要终点
研究者
Daniel Rodríguez Almagro
Physiotherapist
University of Jaén