Ranscutaneous Electrical Nerve Stimulation As An Adjunct To Standard Conservative Therapy For Early Pain Control In Temporomandibular Disorders: A Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain at rest assessed by Visual Analog Scale (VAS)
研究概览
简要总结
To evaluate whether adding conventional transcutaneous electrical nerve stimulation (TENS) to a standard conservative regimen (patient education, pharmacotherapy, and a home exercise programme) provides additional short- and medium-term benefit for pain, mandibular function, and quality of life in patients with temporomandibular disorders (TMD).
详细描述
This was a single-centre, two-arm parallel controlled clinical trial. 48 adults with TMD diagnosed by the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) were enrolled and allocated to a TENS group or a control group. Both groups received identical patient education, a two-week course of dexketoprofen (50 mg/day) plus thiocolchicoside (16 mg/day), and a home exercise programme. The TENS group additionally received conventional TENS (100 Hz, 200 µs, sensory-level, 30 min/session, 5 sessions/week for 2 weeks). Assessments were performed at baseline, after treatment (week 2), and at 3 months (week 12).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years.
- •Patients diagnosed with temporomandibular disorders (TMD) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I.
- •Patients who agreed to participate and signed the informed consent form.
排除标准
- •Facial pain attributable to another condition (sinusitis, migraine, tension-type headache, trigeminal neuralgia).
- •TMJ involvement secondary to an inflammatory systemic disease.
- •TMJ subluxation.
- •Degenerative cervical disease restricting neck movement.
- •Any contraindication to TENS.
结局指标
主要结局
Pain at rest assessed by Visual Analog Scale (VAS)
时间窗: Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up)
Pain intensity at rest will be evaluated using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores represent worse outcome/greater pain intensity.
次要结局
- Pain during jaw function assessed by Visual Analog Scale (VAS)(Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up))
- Temporomandibular joint dysfunction assessed by the Modified Helkimo Clinical Dysfunction Index(Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up))
- Mandibular range of motion measured in millimeters using a digital caliper(Baseline, week 2 (immediately post-treatment), and week 12 (3 months follow-up))
研究者
Nilay Sahin
Assistant Professor
Balikesir University