Effectiveness of Visceral Manual Therapy in Bruxist Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Pressure pain threshold (PPT) Baseline-1
研究概览
简要总结
Objective: check the effectiveness of visceral manual therapy on bruxist patients Design: Experimental, analytical, longitudinal, prospective, randomized, single-blind study with a blinded evaluator.
Subjects: 68 subjects over 18 years old, with bruxism (diagnoses by a dentist). Methods: Subjects will be randomized into 2 groups: an experimental group (EG) to which a visceral manual technique will be applied and a control group (CG) to which a placebo manual technique will be administered. Both groups will receive 2 interventions one week apart. The measurements will be made before and after the interventions, and a last measurement will be made one month after the last intervention. Therefore, the patient will visit the center 3 times.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with bruxism diagnosed and referred by a dentist
- •Age: older than 18 years-old.
排除标准
- •Recent craniofacial, mandibular or cervical trauma or fracture.
- •Temporomandibular joint surgery.
- •Acute pain due to other components of the masticatory system (caries, inflammation of the dental root).
- •Abdominal surgery.
- •Gastric ulcers.
- •Gastritis.
- •Previous or current gastric neoplasm.
- •Neurological or systemic diseases.
- •Pregnant, including the period of breastfeeding.
- •Patients receiving chemotherapy or radiotherapy.
- •Cognitive, psychosomatic or psychiatric illnesses that may affect the data obtained.
- •Basic systemic disease of rheumatic origin (for example, arthritis, osteoarthritis, gout and psoriasis).
- •Cerebrovascular and brain diseases.
- •Arrhythmia and other cardiac problems.
- •Implanted electronic devices.
- •Drug or alcohol abuse, analgesic or sedative therapy, and use of medications that affect the central nervous system (for example, antidepressants, anxiolytics, and anticonvulsants).
- •Patients who have previous experience with manual treatment of the diaphragm
结局指标
主要结局
Pressure pain threshold (PPT) Baseline-1
时间窗: Baseline pre-intervention
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
PPT Change-1
时间窗: Change from "PTT Baseline-1" immediately post-intervention
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
PPT Baseline-2
时间窗: Baseline pre-intervention at 7 days
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
PPT Change-2
时间窗: Change from "PTT Baseline-2" immediately post-intervention
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
PPT Change-3
时间窗: Change from "PTT Baseline-2" and "PTT Change-2" at 1 month
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Heart Rate Variability (HRV) Baseline-1
时间窗: Baseline pre-intervention
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
HRV Change-1
时间窗: Change from "HRV baseline-1" inmediately post-intervention
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
HRV Baseline-2
时间窗: Baseline pre-intervention at 7 days
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
HRV Change-2
时间窗: Change from "HRV baseline-2" inmediately post-intervention
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
HRV Change-3
时间窗: Change from "HRV baseline-2" and "HRV change-2" at 1 month
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Myotonometry baseline-1
时间窗: Baseline pre-intervention
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Myotonometry change-1
时间窗: Change from "myotonometry baseline-1" inmediately post-intervention
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Myotonometry baseline-2
时间窗: Baseline pre-intervention at 7 days
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Myotonometry change-2
时间窗: Change from "myotonometry baseline-2" inmediately post-intervention
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Myotonometry change-3
时间窗: Change from "myotonometry baseline-2" and "myotonometry change-2" at 1 month
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
次要结局
- Cervical Range of Motion (CROM) Baseline-1(Baseline pre-intervention)
- Cervical Range of Motion (CROM) Change-1(Change from "CROM Baseline-1" immediately post-intervention)
- Cervical Range of Motion (CROM) Baseline-2(Baseline pre-intervention at 7 days)
- Cervical Range of Motion (CROM) Change-2(Change from "CROM Baseline-2" immediately post-intervention)
- Cervical Range of Motion (CROM) Change-3(Change from "CROM Baseline-2" and "CROM Change-2" at 1 month)
- Perceived Stress Scale (PSS-14) Baseline(Baseline)
- PSS-14 Change(Change from Baseline PSS-14 at 1 month)
- Mandibular Mobility Baseline-1(Baseline pre-intervention)
- Mandibular Mobility Change-1(Change from "Mandibular Mobility Baseline-1" immediately post-intervention)
- Mandibular Mobility Baseline-2(Baseline pre-intervention at 7 days)
- Mandibular Mobility Change-2(Change from "Mandibular Mobility Baseline-2" immediately post-intervention)
- Mandibular Mobility Change-3(Change from "Mandibular Mobility Baseline-2" and "Mandibular Mobility Change-2" at 1 month)
- Pittsburgh Sleep Quality Index (PSQI) Baseline(Baseline)
- PSQI Change(Change from Baseline PSQI at 1 month)
研究者
Lourdes María Fernández Seguín
Assistant Professor. Physiotherapy Department
University of Seville