Efficacy of Myofascial Induction as a Manual Therapy Technique in Patients With Anxiety. A Randomized Double Blind Clinical Trial Controlled With Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- State-Trait Anxiety Inventory (STAI)
研究概览
简要总结
This study evaluates the efficacy of a myofascial intervention as a technique within manual therapy in the treatment of clinical anxiety in adults. Half of the participants will receive a myofascial intervention program, while the other half will receive a sham myofascial intervention.
详细描述
Within physiotherapy, some studies have been carried out with psychological outcome measures, mainly from therapeutic exercise, but there continues to be an important documentary gap and the few results are not conclusive.
The myofascial approach is presented as an effective tool for the treatment of different pathologies, mainly musculoskeletal. However, few are the studies that relate it to psychological variables and specifically to improve anxiety levels.
The myofascial approach is proposed as a fast and low-cost tool for the management of clinical anxiety.
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)
盲法说明
Patients will be assigned to two groups:
- Experimental group: who will receive myofascial intervention
- Control / placebo group: who will receive sham myofascial intervention
Neither the participants assigned to the groups nor the evaluators who measure the variables know to which group the subjects belong.
Participants will be randomly assigned through the GraphPad software.
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
- •Be between 18 and 65 years old
- •Subjects with high levels of anxiety
- •Subjects who speak and understand Spanish correctly
- •Subjects without previous experience in myofascial treatment
排除标准
- •Subjects with a clinical history of cognitive impairment
- •Subjects with systemic, neurological or muscular diseases
- •Subjects with some type of aneurysm diagnosed
- •Subjects with diagnosed extremely high blood pressure
- •Subjects with diagnosed malignant tumors
- •Subjects with diagnosed vertebrobasilar insufficiency
- •Subjects with a diagnosed dermatological condition
- •Subjects diagnosed with epilepsy
- •Pregnant women or with the possibility that they may be
结局指标
主要结局
State-Trait Anxiety Inventory (STAI)
时间窗: Change from baseline (pre-treatment), immediately after myofascial intervention (intrasession), through study completion (an average of 1 month), 3 and 6 months follow-up
It consists of a self-report to evaluate two independent concepts about anxiety: anxiety as a state ("in this moment") and anxiety as a trait ("in most cases"). Each of these subscales has a total of 20 items in a 4-point Likert response system according to intensity (0 = not at all; 3 = a lot). The total score in each of the subscales ranges from 0 to 60 points.
次要结局
- Beck Depression Inventory (BDI)(Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up)
- General Health Questionnaire (GHQ-12)(Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up)
- Patient Health Questionnaire (PHQ-15)(Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up)
- Central Sensitization Inventory (CSI)(Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up)
- Visual Analogue Scale (VAS)(Change from baseline (pre-treatment), immediately after myofascial intervention (intrasession), through study completion (an average of 1 month), 3 and 6 months follow-up)
研究者
Rodrigo Gozalo Pascual
Physical / Manual Therapist (PT, PhD Student), Biomechanics Professor
Universidad Complutense de Madrid