The Effect of Diadynamic Current Combined With Rehabilitation in Patients With Bruxism: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pain Assessment
研究概览
简要总结
This study was designed to investigate the effectiveness of diadynamic current, one of the electrotherapy methods added to rehabilitation in the treatment of bruxism. Individuals over the age of 18 diagnosed with bruxism will be randomly assigned to one of the following groups using the sealed envelope method: rehabilitation program (control group) or rehabilitation program combined with diadynamic current (experimental group). The intervention will consist of an exercise program conducted jointly for the experimental and control groups. Participants will be given a structured exercise program to be performed in person 3 days a week for 6 weeks. In addition to the exercise program, the experimental group will receive diadynamic current treatment at each session. Pain intensity will be assessed using the Visual Analog Scale (VAS), pressure pain threshold with an algometer, muscle strength with a hand-held dynamometer, bite force with a pinch meter, maximal mouth opening with a caliper, and head posture with the craniovertebral angle. Oral habits will be evaluated using the Oral Behavior Checklist, and anxiety levels will be assessed with the State-Trait Anxiety Inventory (STAI).
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
- None
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
- •The study will include patients of both genders who have been clinically diagnosed with bruxism over the age of 18 and who report pain around the jaw (3 or higher on the VAS), and who have provided informed consent.
排除标准
- •Patients who have previously used physical therapy or complementary-alternative medicine methods for similar complaints, those with neurological or psychiatric disorders, those with systemic diseases, those with pacemakers or implantable defibrillators; those with a history of cancer, those with an acute infection in the relevant area, those with a history of trauma to the jaw area, those using muscle relaxants, analgesics, or non-steroidal anti-inflammatory drugs, those who have participated in another study within the last 6 months, and individuals who do not agree to participate in the study will be excluded.
研究组 & 干预措施
Rehabilitation Program
Participants will be given a structured exercise program to be performed in person 3 days a week for 6 weeks.
干预措施: Exercise Program (Other)
Rehabilitation Program with Diadynamic Current
In addition to the rehabilitation program, participants will receive diadynamic current therapy during each session.
干预措施: Diadynamic current therapy applied in conjunction with exercise (Other)
结局指标
主要结局
Pain Assessment
时间窗: Baseline
To determine patients' pain levels, pain intensity at rest and during activity was measured using a Visual Analog Scale (VAS). A 10-centimeter (cm) horizontal line was used on this scale, grading from "0: no pain" to "10: unbearable pain." Patients were asked to rate their current pain within this range.
Pressure Pain Assessment
时间窗: Baseline
The pressure pain threshold around the temporomandibular joint in the masseter and temporalis muscles will be assessed bilaterally using an algometer. The patient will be asked to indicate when the applied pressure first causes pain. The average of the 3 measurements will be recorded on the assessment form in kg/cm².
Muscle Strength Assessment
时间窗: Baseline
Muscle strength during jaw opening, closing, lateral movements to the right and left, and protrusion will be measured using a hand-held dynamometer. While performing these movements, counterforce will be applied in the opposite direction. Muscle strength will be recorded in Newtons (N).
Bite Force
时间窗: Baseline
Individuals' bite forces will be assessed using a pinchmeter. Three bite repetitions will be performed to determine the central bite force between the incisors and the lateral bite force between the right and left lateral posterior arches, and the average will be recorded in kilograms.
Maximum Mouth Opening
时间窗: Baseline
The maximum mouth opening will be measured with a caliper and recorded in centimeters (cm).
Pain Assessment
时间窗: 6 weeks
To determine patients' pain levels, pain intensity at rest and during activity was measured using a Visual Analog Scale (VAS). A 10-centimeter (cm) horizontal line was used on this scale, grading from "0: no pain" to "10: unbearable pain." Patients were asked to rate their current pain within this range.
Pressure Pain Assessment
时间窗: 6 weeks
The pressure pain threshold around the temporomandibular joint in the masseter and temporalis muscles will be assessed bilaterally using an algometer. The patient will be asked to indicate when the applied pressure first causes pain. The average of the 3 measurements will be recorded on the assessment form in kg/cm².
Muscle Strength Assessment
时间窗: 6 weeks
Muscle strength during jaw opening, closing, lateral movements to the right and left, and protrusion will be measured using a hand-held dynamometer. While performing these movements, counterforce will be applied in the opposite direction. Muscle strength will be recorded in Newtons (N).
Bite Force
时间窗: 6 weeks
Individuals' bite forces will be assessed using a pinchmeter. Three bite repetitions will be performed to determine the central bite force between the incisors and the lateral bite force between the right and left lateral posterior arches, and the average will be recorded in kilograms.
Maximum Mouth Opening
时间窗: 6 weeks
The maximum mouth opening will be measured with a caliper and recorded in centimeters (cm).
次要结局
- Head Posture(Baseline)
- Determining the Oral Habits(Baseline)
- Determining the Anxiety Level(Baseline)
- Determining the Sleep Quality(Baseline)
- Head Posture(6 weeks)
- Determining the Oral Habits(6 weeks)
- Determining the Anxiety Level(6 weeks)
- Determining the Sleep Quality(6 weeks)
研究者
BÜŞRA CANDİRİ
assistant professor
Inonu University