Study on Imaging Characteristics and Predictive Radiology of Brain Network Regulation by Acupuncture in Patients with Painful Temporomandibular Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Temporomandibular disorder (TMD) is a common musculoskeletal pain condition affecting the jaw, and acupuncture is often used for treatment, though its neurological mechanisms are unclear. This study investigates the neural mechanisms of acupuncture in TMD using functional MRI (fMRI), structural MRI (sMRI), and diffusion tensor imaging (DTI), alongside machine learning to predict treatment outcomes. This study aims to enhance understanding of acupuncture's effects on TMD and improve personalized treatment approaches.
详细描述
A randomized, single-blind, sham-controlled trial will enroll 48 patients, divided into acupuncture and sham acupuncture groups. The study will consist of a 1-week baseline, 4-week treatment, and 8-week follow-up period, with 30-minute sessions three times a week for 12 sessions. Primary outcomes include changes in Visual Analog Scale (VAS) scores at week 4, with secondary outcomes including VAS changes at week 8, jaw function, and scores on pain, sleep, and mental health scales. Multimodal MRI scans will assess brain changes at baseline, post-treatment, and follow-up. Our research is a randomized controlled trial (RCT) combining sMRI, fMRI, and DTI to explore the efficacy of acupuncture in TMD treatment, using multi-modal imaging to provide a comprehensive biological profile of TMD patients. Our study aims to (1) analyze brain structural and functional network changes post-acupuncture, explore the relationship between central imaging and clinical symptom changes, and (2) predict individual treatment outcomes for TMD.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having a history of pain-related TMD for at least three months;
- •Aged between 18 and 70 years;
- •Voluntary participation in the trial with signed informed consent.
排除标准
- •Having received occlusal splint, injection therapy, acupuncture, biofeedback, transcutaneous nerve stimulation, or TMD-specific medication (e.g., corticosteroids, benzodiazepines, sedative hypnotics, muscle relaxants, opioids, antidepressants, or anticonvulsants) for managing facial pain within one month before the screening period;
- •Having suffered from pain of dental origin, trauma, sinus pathology, neuropathic origin, inflammatory systemic diseases and cancer;
- •Having a history of rheumatoid arthritis;
- •Presence of mental illness or substance abuse;
- •Pregnant, lactating, or planning to become pregnant;
- •Participants with common contra-indications for MRI such as claustrophobia or metal implants.
研究组 & 干预措施
acupuncture
Patients in the acupuncture group will receive treatment at specified acupoints, performed by acupuncturists with at least five years of experience. The acupoints include bilateral Hegu (LI4), Yanglingquan (GB34), and affected-side Jiache (ST6), Xiaguan (ST7), and Tinggong (SI19).
干预措施: Acupuncture (Other)
sham acupuncture
Patients in the sham group will receive noninvasive acupuncture at the same acupoints as the acupuncture group. Sham needles, which resemble real needles but are blunt and slide within their handles, will be applied using the Park Sham device, secured to the skin with a self-adhesive pad. The procedure of manipulation is the same as for acupuncture, but without Deqi.
干预措施: Sham treatment (Other)
结局指标
主要结局
Visual Analog Scale
时间窗: From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16)
The VAS is a self-administered instrument, ranging from 0 (no pain at all) to 10 (worst imaginable pain).
次要结局
- Magnetic Resonance Imaging(From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16))
- Effective response rate(From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16))
- Jaw Opening and Movement(From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16))
- Graded Chronic Pain Scale(From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16))
- Jaw Function Limitation Scale-20(From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16))
- Depression Anxiety and Stress Scale-21(From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16))
- Pittsburgh Sleep Quality Index(From baseline (week 0) to the end of treatment (week 4) and the end of follow-up period (week 16))
- Pressure Pain Threshold(From baseline (week 0) to the end of treatment (week 4))
研究者
Li bin
Professor
Beijing Hospital of Traditional Chinese Medicine