Dry Needling and Spinal Manipulation or Interocclusal Appliance (Splint), NSAIDs and Joint Mobs for Temporomandibular Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
The purpose of this research is to compare two different approaches for treating patients with temporomandibular dysfunction (TMD): Dry needling and spinal manipulation or Interocclusal Appliance (Splint), NSAIDs and Temporomandibular Joint Mobilization . Clinicians commonly use all of these techniques to treat TMD. This study is attempting to find out if one treatment strategy is more effective than the other.
详细描述
Patients with stress temporomandibular dysfunction will be randomized to receive 1-2 treatment sessions per week for up to 4 weeks ( up to 8 sessions total) of either: (1) dry needling and spinal manipulation or (2) Interocclusal appliance (splint), NSAIDs, temporomandibular joint mobilization.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 18 years old
- •Patient referred to physical therapy from a physician or dentist with a diagnosis of temporomandibular dysfunction that is consistent with the Revised TMD Group 1 Muscle Disorders Diagnostic Algorithm. (Dworkin et al.1992; Look et al., 2010]. According to Blanco-Hungria et al. (2015), this category represents 88.7% of patients with TMD.
- •History of symptoms related to TMD for at least 3 months
- •Intensity of pain related to TMD at least 30mm out 100 per Visual Analogue scale (La Touche et al, 2009; Gonzalez-Ingesias et al., 2013)
- •Patient presents with the following: (Gonzalez Perez et al., 2015)
- •Strong pain in the anterior part of the lower belly of the LPM on palpation
- •Deep-seated pain in the TMJ and/or region of the maxillary sinus (referred pain)
- •Significant motor dysfunction (e.g. limited jaw opening, painful protrusion of the chin against resistance, mandibular lateralization to the opposite side upon opening).
排除标准
- •Report of red flags to manual physical therapy to include: severe hypertension, infection, ankylosing spondylitis, neoplasm, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic, ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
- •Signs or symptoms of disc displacement, arthrosis or arthritis of the temporomandibular joint according to category II and III of the Research Diagnostic Criteria for Temporomandibular Disorders
- •History of traumatic injury such as a fracture or whiplash
- •Concomitant diagnosis of any primary headache (i.e. tension type headache or Migraine) except cervicogenic headaches
- •History of surgery related to TMD
- •Diagnosis of fibromyalgia
- •Systemic disease such as RA, lupus erythematosus or psoriatic arthritis
- •Presence of neurological disorder such as trigeminal neuralgia
- •History of PT, acupuncture or splint treatment within 3 months of the study
- •History of taking prescription NSAIDs within 3 months of the study
- •History of regularly taking non-prescription NSAIDs (i.e. more than intermittent) within 3 months of the study
- •Known sensitivity to acetylsalicylic acid, with impaired coagulation or with ulcer, kidney or liver problems.
- •Cadiac pacemaker, metal allergy or severe needle phobia
- •Serious cardiovascular, cerebral disease, psychiatric disorder or cognitive Impairment
研究组 & 干预措施
Dry Needling and Spinal Manipulation
干预措施: Dry Needling (Other)
Dry Needling and Spinal Manipulation
干预措施: Spinal manipulation (Other)
Interocclusal Appliance, NSAIDs and TMJ Mobs
干预措施: Interocclusal Appliance (Other)
Interocclusal Appliance, NSAIDs and TMJ Mobs
干预措施: NSAIDs (Drug)
Interocclusal Appliance, NSAIDs and TMJ Mobs
干预措施: TMJ Mobs (Other)
结局指标
主要结局
Visual Analogue Scale
时间窗: baseline, 2 weeks, 6 weeks, 3 months
Change in average jaw pain intensity rated by the patient over last 24 hours and last 7 days (VAS: 0-100mm) between baseline and the following time points: 2 weeks, 6 weeks and 3 months. Even though patients will be treated 1-2 treatments per week for 4 weeks (up to 8 treatments total), the visual analogue score after 2 weeks of treatment, at 6 weeks (2 weeks post treatment) and at 3 months (2 months post treatment) will be compared to baseline (pre-treatment). Scores closer to 0 represent less pain.
次要结局
- Global Rating of Perceived Change(2 weeks, 6 weeks, 3 months)
- Active Pain Free Mouth Opening(baseline, 2 weeks, 6 weeks, 3 months)
研究者
James Dunning, DPT, MSc, FAAOMPT
Principal Investigator
Alabama Physical Therapy & Acupuncture