Short-Term Clinical and Electromyographic Changes Following Adjunctive Acupuncture in Adults With Persistent Myofascial Temporomandibular Disorder Pain Despite Long-Term Occlusal Splint Use: An Exploratory Single-Arm Pre-Post Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity Assessed With the 11-Point Numeric Rating Scale
研究概览
简要总结
Temporomandibular disorders (TMDs) can cause persistent pain in the jaw muscles and limitations in jaw function. Occlusal splints are commonly used to manage these symptoms, but some patients continue to experience pain despite long-term splint use.
The purpose of this exploratory study was to describe short-term changes after adding acupuncture to ongoing occlusal splint therapy in adults with persistent myofascial TMD pain. The study included 30 adults who had experienced pain in the masseter and/or temporalis muscles for more than 12 months and had used a maxillary full-arch stabilization splint for at least five consecutive years while remaining symptomatic.
All participants continued their occlusal splint therapy and received four 30-minute acupuncture sessions, administered once per week. Assessments were performed before the first acupuncture session and after the fourth session. The assessed outcomes were pain intensity, the amount of pressure required to produce pain in the jaw muscles, maximum mouth opening, and the electrical activity of the masseter and temporalis muscles.
All participants received the same intervention, and there was no control or comparison group. The study was therefore designed to characterize short-term changes within participants rather than to determine whether acupuncture was superior to another treatment or whether it directly caused the observed changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 years or older.
- •Ability to understand the study procedures and provide written informed consent.
- •Diagnosis of myalgia according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I.
- •Persistent or recurrent pain in the masseter and/or temporalis muscles for more than 12 months, including pain during the 30 days before enrollment, with muscular pain confirmed by clinical examination.
- •Use of a maxillary full-arch stabilization splint for at least five consecutive years before enrollment.
- •Persistence of temporomandibular disorder-related muscular pain despite ongoing occlusal splint use.
排除标准
- •History of significant trauma to the temporomandibular joint.
- •Poorly controlled systemic metabolic disease.
- •Active cancer.
- •Pregnancy.
- •Significant neurological disorder.
- •Use of medications affecting neuromuscular function during the 30 days before enrollment.
- •Needle phobia.
- •Inability to comply with the intervention and assessment schedule.
研究组 & 干预措施
Adjunctive Acupuncture With Ongoing Occlusal Splint Therapy
Participants who remained symptomatic despite at least five years of maxillary full-arch stabilization splint use continued their existing splint regimen and received four 30-minute acupuncture sessions administered once per week. Acupuncture was performed bilaterally at LI4, ST5, ST6, ST7, and ST8. Clinical and surface electromyographic outcomes were assessed before the first acupuncture session and after the fourth session.
干预措施: Adjunctive Acupuncture (Procedure)
结局指标
主要结局
Change in Pain Intensity Assessed With the 11-Point Numeric Rating Scale
时间窗: Baseline and week 5.
Participants rated their current orofacial pain intensity using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable). Change was calculated as the post-intervention score minus the baseline score. Negative change values indicate a reduction in pain intensity.
次要结局
- Change in Pressure Pain Threshold of the Masseter and Temporalis Muscles(Baseline and week 5.)
- Change in Maximum Mouth Opening(Baseline and week 5.)
- Change in Surface Electromyographic Root Mean Square Amplitude at Mandibular Rest(Baseline and week 5.)
- Change in Surface Electromyographic Peak Amplitude at Mandibular Rest(Baseline and week 5.)
- Change in Surface Electromyographic Root Mean Square Amplitude During Maximum Intercuspation(Baseline and week 5.)
- Change in Surface Electromyographic Peak Amplitude During Maximum Intercuspation(Baseline and week 5.)