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临床试验/NCT03848169
NCT03848169Unknown不适用

Pulsed Radiofrequency As A Treatment For Mastecatory Muscle Pain In Temporomandibular Disorder Patients

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Change in static and dynamic TMD pain

研究概览

简要总结

PRF of the masticatory muscles (masseter, temporalis, medial and lateral pterygoid muscle) can improve pain intensity and functional recovery of the jaw in patients with extra-articular TMD.

详细描述

The temporomandibular joint is formed by the mandibular condyle inserting into the mandibular fossa of the temporal bone. Muscles of mastication are primarily responsible for the movement of this joint. Its functionality may be affected by different disorders that are characterized by craniofacial pain involving the joint, masticatory muscles, or muscle innervations of the head and neck. These are known as temporomandibular disorders (TMD). It affects 10% to 15% of adults, but only 5% seek treatment. The incidence of TMD peaks from 20 to 50 years of age and are more common in female population.

TMD is categorized as intra-articular (within the joint) or extra-articular (involving the surrounding musculature). Musculoskeletal conditions (myofascial pain disorder) are the most frequent cause of TMD, accounting for at least 50% of cases. Thus, musculoskeletal conditions associated with TMD include spasm and/or tenderness to palpation of the masseter, temporalis, and/or pterygoid muscles.

Etiology of TMD is multifactorial. Factors consistently associated with TMD include other pain conditions, fibromyalgia, autoimmune disorders, sleep apnea and psychiatric illness. According to the literature, there is 1.8-fold increase in myofascial pain in people with anxiety.

It is important to mention that patients with TMD present with an increase risk to develop chronic and intense headaches. The relationship between chronic TMD and various headaches could be due to similarity in the pathophysiology of both diseases.4-6 Studies suggest, that the trigeminal nucleus contribute to central sensitization associated to interference in descending modulation, and could produce the amplification of pain in this region.

Treatment for TMD is complicated and requires specific knowledge and exercises to strengthen some groups of muscles and stretch others, occlusal splint therapy, massage, trigger point injections, and pharmacotherapy. Although the management seems difficult, most of the patients experience successful improvement once a proper protocol has been established. Muscle relaxants (baclofen, tizanidin, cyclobenzaprine), nonsteroidal anti-inflammatory drugs (NSAIDS), opioids, anticonvulsants (e.g., gabapentin), ketamine, tricyclic antidepressants (e.g., amitriptyline) and benzodiazepines, have also been used clinically for TMD management, but there is no evidence that supports or refutes the effectiveness of these medications. In some cases where patients present with severe acute pain, or chronic pain secondary to serious TMD, inflammation, or degeneration, minimally invasive and invasive procedures should be considered.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Thirty consecutive patients, male and female, between 18 and 80 years old, with extra-articular TMD as diagnosed by a specialist of the Maxillofacial team based on Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) for Clinical and Research Applications, with chronic pain related to TMD (for more than three months according to IASP definition), and who have plateaued with conventional treatment in the past three months, will be prospectively recruited at the Maxillofacial Surgery Clinic

排除标准

  • • Patients younger than 18 years old.
  • ASA physical status >3,
  • Contraindication for local anesthetics or RF.
  • Immunosuppression or high risk of infection.
  • Coagulation impairment.
  • Patients with psychiatric illness.
  • Patients with cognitive impairment.
  • Patients currently taking opioids.
  • Patients that had botulinum toxin or steroid injections in the head or neck area in the past three months.
  • Patient with pacemaker.
  • Patient with prosthetic joint replacement, or placement of any metallic surgical device in or around the area of treatment.
  • Infection of the TMJ.
  • Muscular dystrophy.
  • Pathology or impaired masticatory muscles.
  • Pregnancy.
  • Autoimmune diseases.
  • Arthralgia or intra-articular joint dysfunction.
  • Patients with allergy to Cefazolin.

研究组 & 干预措施

Experimental group

Experimental

Ultrasound guidance will be used with a high- frequency linear transducer.After the joint has been identified, the researcher will ask the patient to hold mouth in a neutral position. Masseter, temporalis, medial and lateral pterygoid muscles will be then identified, and with a sterile marker the operator will determine the best point of entry for each muscle injection. Lidocaine 1% will be injected for the skin, always under ultrasound vision. RF needle (18 G, 50 mm of length and active tip of 3 mm) will be inserted into each one of the muscles mentioned previously. Then, through the RF needle, 0.5 ml of normal saline will be injected (to decrease the impedance of the tissues), the electrode will be inserted, and extra-articular PRF will be performed during 4 minutes at 42 degrees Celsius for each muscle. At the end of each muscle treatment, 1 ml of local anesthetic (lidocaine 1%) will be injected through the RF needle, and the needle will be removed.

干预措施: Radiofrequency (Other)

Control Group

Sham Comparator

Ultrasound guidance will be used with a high- frequency linear transducer. After the joint has been identified, the researcher will ask the patient to hold his or her mouth in a neutral position. Masseter, temporalis and lateral pterigoid muscles will be then identified, and with a sterile marker the operator will determine the best point of entry for each muscle injection (mainly over the most common sites of trigger points for the masticatory muscles). Lidocaine 1% will be injected for the skin, always under ultrasound vision. RF needle (18 G, 50 mm of length and active tip of 3 mm) will be inserted into each one of the muscles mentioned previously. Then, through the RF needle, an electrode will not be inserted, but a simulation for PRF will be done during 4 minutes for each muscle (sham). At the end of each muscle puncture, 1 ml of local anesthetic (lidocaine 1%) will be injected through the needle, and the needle will be removed.

干预措施: Radiofrequency (Other)

结局指标

主要结局

Change in static and dynamic TMD pain

时间窗: 30 minutes, 4 and 12 weeks post procedure

using Numerical Rating Scale (NRS) at the end of the procedure (NRS post-procedure), and in the follow-up at 4 weeks and 12 weeks post-procedure.

次要结局

  • Change in lateral jaw excursion(30 minutes, 4 and 12 weeks post procedure)
  • Pain medications use(30 minutes, 4 and 12 weeks post procedure)
  • change in maximal mouth opening(30 minutes, 4 and 12 weeks post procedure)
  • Change in jaw protrusion(30 minutes, 4 and 12 weeks post procedure)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

JF Asenjo

Professor

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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