Photobiomodulation for the Management of Temporomandibular Disorder Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable
研究概览
简要总结
Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but there is no indication for TMD. Our goal in this study is to conduct a clinical trial of multimodal PBM for TMD pain. Also, we propose to determine if PBM-induced changes in inflammation contribute to PBM's analgesic effects. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Provides a signed and dated informed consent form
- •Is at least 18 years of age (male or female and any race or ethnicity)
- •Meets diagnostic criteria for TMD, ( Masticatory Muscle Disorders, 1A: Myalgia)
- •Has experienced facial pain for at least 3 months
- •At Screening and Baseline Visit (Visit 0), reports an average pain intensity rating over the past week of ≥ 30 on a numerical rating scale (0-100)
排除标准
- •Starting a new daily prescription medication for the management of pain within 30 days prior to treatment session;
- •Use of any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 2 weeks prior to the CATI;
- •Starting occlusal appliance therapy within 30 days prior to CATI; d) history of facial trauma or orofacial surgery within 6 weeks prior to CATI;
- •Active orthodontic treatment;
- •Psychiatric hospitalization within one year prior to screening.
- •Has known hypersensitivity to laser therapy.
- •Currently being treated with chemotherapy or radiation therapy
- •Has been treated with another investigational drug or treatment within 30 days prior to the Screening and Baseline Visit
- •Is pregnant or nursing
- •Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
结局指标
主要结局
Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable
时间窗: Through study completion; an average of 10 weeks
Using a numerical rating scale (NRS) requires the patient to rate their pain on a defined scale 0=no pain and 100=the most intense pain imaginable to rate the average daily pain from Daily Pain \& Symptom Dairy over one week prior to V1 will be compared to the average daily pain one week prior to V8.
次要结局
未报告次要终点