Adding Core Stabilization Training to Orofacial Manuel Therapy in Individuals With Temporomandibular Joint Disc Displacement With Reduction: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Pain severity: VAS
研究概览
简要总结
This study aims to compare the effectiveness of three different treatment approaches in individuals with DDwR symptoms. It is hypothesized that adding core stabilization training (CST) to orofacial manual therapy (OMT) will enhance treatment outcomes. Patients will be treated for 10 sessions once a week, for a total of 10 weeks. Evaluation was planned to be done twice, at the beginning and end of the treatment.
详细描述
This study aims to compare the effectiveness of three different treatment approaches in individuals with DDwR symptoms. It is hypothesized that adding core stabilization training (CST) to orofacial manual therapy (OMT) will enhance treatment outcomes. The patients to be included in the study will be randomly divided into three groups and it is planned to include 15 people in each group. Home exercises and patient education will be provided to all patients.
- Group 1 (CST group): Orofacial manual therapy + core stabilization training (CST) + home exercise and patient education
- Group 2 (OMT group): Orofacial manual therapy (OMT) + home exercise and patient education
- Group 3 (Control group): Home exercise and patient education.
Pain intensity, pressure pain threshold, joint range of motion, posture, flexibility, stabilization of core muscles, functionality and sleep quality will be evaluated by using Numeric Pain Scale (NPS), digital algometer, ruler, Palpation Meter (PALM), bubble inclinometer, tape measure, Finger-to-floor distance (EPZM) and sit-reach test, pressure biofeedback unit, "Helkimo Index", "Pittsburgh Sleep Quality Index (PUKI)" respectively. Patients will be treated for 10 sessions once a week, for a total of 10 weeks. Evaluation was planned to be done twice, at the beginning and end of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants did not know which treatment group they were in.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteered to participate,
- •Aged between 18-60 years old,
- •Having the diagnosis of Temporomandibular Disorders (TMD) - Reduction Disc Displacement (DDwR)
排除标准
- •Having a malignant condition, trauma and surgery of the cranial and cervical region,
- •Not being cooperative,
- •Regular use of analgesic and anti-inflammatory drugs,
- •Having dentofacial anomalies,
- •Having active arthritis,
- •Having lumbal pathology,
- •Having metabolic diseases,
- •Having connective tissue, rheumatological and hematological disorders,
- •Having a diagnosed psychiatric illness,
- •Receiving TMD-related physical therapy less than 6 months ago
结局指标
主要结局
Pain severity: VAS
时间窗: Change from Baseline pain severity at 10 weeks.
The severity of pain in the orofacial region was evaluated using a Numeric Pain Scale (NPS). The patients were instructed to mark the level of pain felt during rest, clenching and maximum mouth opening on a 10-cm line ranging from 0 (no pain) to 10 (intolerable pain).
Pain Threshold: Digital algometer
时间窗: Change from Baseline pain threshold at 10 weeks.
The algometer is a reliable instrument for measuring the sensitivity of the masticatory muscles. The measurement will be made at 8 points. A force (Newton in force) of 1 kg (weight in kilogram) per square centimeter (surface area in centimeter square) is applied to the patient for 3 seconds, and this is continued until the patient feels pain (weight and surface area will be combined to report Newton in kg/ cm2). The physiotherapist will passively support the individual's head with the other hand. This process will be repeated three times and the average value will be calculated.
Range of Motion
时间窗: Change from Baseline range of motion at 10 weeks.
Mouth opening, protrusion and right and left lateral deviation will be measured starting from 0 using a 15 cm ruler. Repeated measuring reduces the standard error of measurement, hence repeated measurements were also included in our study (three times) with the largest recorded range taken.
Facial asymmetry
时间窗: Change from Baseline facial asymmetry at 10 weeks.
For facial asymmetry evaluation, the distance between the anterior notch of the chin and the mandible line will be measured with a tape measure.
Degree of pelvic tilt
时间窗: Change from Baseline degree of pelvic tilt at 10 weeks.
Palpation Meter (PALM), (Salt Lake City, United Kingdom, USA) will be used for pelvic tilt evaluation. The Palpation Meter has an angle inclinometer and two 360-swivel arms, one of arms will be placed in the Spina iliaca Anterior Superior (SIAS) and the other in the Spina iliaca Posterior Superior (SIPS). In this position, the angle indicated by the inclinometer will be recorded as the pelvic tilt angle.
Degree of lordosis
时间窗: Change from Baseline degree of lordosis at 10 weeks.
Bubble inclinometer (White Plains, New York 10602 USA) will be used for lumbar lordosis evaluation. The degree of lordosis will be determined by measuring the spinous processes of the T12-L1 and S2-3 vertebrae with a bubble inclinometer and adding the degrees found.
Range of Motion
时间窗: Change from Baseline range of motion at 10 weeks.
Mouth opening, protrusion and right and left lateral deviation will be measured starting from 0 using a 15 cm ruler. Repeated measuring reduces the standard error of measurement, hence repeated measurements were also included in our study (three times) with the largest recorded range taken.
Facial asymmetry
时间窗: Change from Baseline facial asymmetry at 10 weeks.
For facial asymmetry evaluation, the distance between the anterior notch of the chin and the mandible line will be measured with a tape measure.
Degree of pelvic tilt
时间窗: Change from Baseline degree of pelvic tilt at 10 weeks.
Palpation Meter (PALM), (Salt Lake City, United Kingdom, USA) will be used for pelvic tilt evaluation. The Palpation Meter has an angle inclinometer and two 360-swivel arms, one of arms will be placed in the Spina iliaca Anterior Superior (SIAS) and the other in the Spina iliaca Posterior Superior (SIPS). In this position, the angle indicated by the inclinometer will be recorded as the pelvic tilt angle.
Degree of lordosis
时间窗: Change from Baseline degree of lordosis at 10 weeks.
Bubble inclinometer (White Plains, New York 10602 USA) will be used for lumbar lordosis evaluation. The degree of lordosis will be determined by measuring the spinous processes of the T12-L1 and S2-3 vertebrae with a bubble inclinometer and adding the degrees found.
Pain severity: VAS
时间窗: Change from Baseline pain severity at 10 weeks.
The severity of pain in the orofacial region was evaluated using a Numeric Pain Scale (NPS). The patients were instructed to mark the level of pain felt during rest, clenching and maximum mouth opening on a 10-cm line ranging from 0 (no pain) to 10 (intolerable pain).
Pain Threshold: Digital algometer
时间窗: Change from Baseline pain threshold at 10 weeks.
The algometer is a reliable instrument for measuring the sensitivity of the masticatory muscles. The measurement will be made at 8 points. A force (Newton in force) of 1 kg (weight in kilogram) per square centimeter (surface area in centimeter square) is applied to the patient for 3 seconds, and this is continued until the patient feels pain (weight and surface area will be combined to report Newton in kg/ cm2). The physiotherapist will passively support the individual's head with the other hand. This process will be repeated three times and the average value will be calculated.
次要结局
- Performance of stabilizer muscles(Change from Baseline lumbopelvic stabilization at 10 weeks.)
- Flexibility of lumbal extensor muscles(Change from Baseline Finger-to-floor distance (EPZM) at 10 weeks.)
- Flexibility of hamstring muscles(Change from Baseline sit-reach test at 10 weeks.)
- Functionality(Change from Baseline Helkimo Index at 10 weeks.)
- Sleep(Change from Baseline Pittsburgh Sleep Quality Index (PUKI) at 10 weeks.)