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临床试验/NCT02810015
NCT02810015Unknown2 期

Treatment of Temporo-Myofascial Disorder of Muscular Origin Using Botulinum Toxin: A Prospective Study

University of Manitoba0 个研究点目标入组 40 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
40
主要终点
Pain (Visual Analog Scale)

研究概览

简要总结

Temporomandibular disorders (TMD) are a group of conditions involving the temporomandibular joint (TMJ), masticatory muscles and associated structures. This broad complex of functional disorders often affects the face and jaws causing chronic pain, earaches, headaches, migraines, neck pain, and dysfunction in many people. Patients that do not find benefit with conservative management require surgical intervention. Recently, the use of botulinum toxin has proven effective and has the potential to bridge the gap between conservative therapy and surgical management resulting in less patients requiring invasive surgery. Objective: We aim to treat TMD of muscular origin using Botulinum toxin injections in the trigger points. Methods: Patients, whose pain originates from trigger points, will be enrolled in this prospective trial. This study will evaluate subjective and objective responses to treatment with botulinum toxin. The pair of masticatory muscles, masseter and temporalis, will be injected with 30 units and 20 units of botulinum toxin, respectively. Subjective outcomes such as pain and orofacial function on a visual analog scale as well as objective outcomes such as maximal interincisal mouth opening, tenderness to palpation to the temporalis and masseter muscles, maximal bite force measured by electromyogram and the reduction in muscle bulk due to muscle disuse atrophy will be assessed. Expected Results: We expect trigger points in these patients to disappear and the associated muscles to become partially paralyzed and relaxed. Consequently, we expect that the TMJ loading will be reduced and that the patient's overall functional ability will increase. We also expect that muscular hypertrophy volume from hyperactivity will decrease due to disuse atrophy and impact their cosmetic image positively. Overall, we hope these changes will result in a reduction in pain and headaches which will consequently improve the participant's diet, nutrition, psychological well being and quality of life.

详细描述

Introduction Temporomandibular disorders (TMD) are a group of conditions involving the temporomandibular joint (TMJ), masticatory muscles and associated structures. This broad complex of functional disorders often affects the face and jaws causing chronic pain, earaches, headaches, migraines, neck pain, and dysfunction in many people 1,2,3,4,5,6. Conservative treatment for TMD is similar to that of other musculoskeletal conditions. Pharmacologic therapy includes the use of anti-inflammatory medications, muscle relaxants, or opioid analgesics7,8,9,10. Physical treatments comprise of dental splints, directed physiotherapy, moist heat therapy, soft diet, massage and acupuncture11,12,13,14,15,16,17,18,19,20,21,22,23,24,25. At the extreme end of the spectrum, surgical management includes arthrocentesis, arthroscopy and open joint procedures26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44. Some patients can find relief with a combination of these previously mentioned interventions; however, none of these have been proven to be consistently effective. Open joint procedures are not reversible while anti-inflammatory medications and narcotics can have undesirable side effects on the gastrointestinal and central nervous system, respectively. Furthermore, many patients suffering from severe chronic pain do not feel relief with even the strongest narcotic analgesics45,46.

TMD has a complex etiology consisting of components from internal derangement of the joint, arthralgia and/or a component of myofascial pain and muscle hyperactivity1,2,3,4. A treatment that has high specificity and low side effects directed solely at the muscular aspect, which presents with signs and symptoms of trigger points, clenching, and bruxism, could produce another avenue of intervention with significant potential. Recently, the use of botulinum toxin has proven effective and has the potential to be such an agent for treatment with patients suffering from TMD and other orofacial pain conditions47,48,49,50,51,52,53,54,55.

Botulinum toxins are exotoxins derived from Clostridium botulinum, a gram-positive, anaerobic, spore-forming organism. There are 8 different subtypes; type A (BTX-A) has been used in recent studies for the treatment of motor disorders such as cervical dystonia or the hyperactive muscular component of TMD53,54,55. The specific method of action of botulinum toxin is on peripheral synapses. In the synaptic cleft, the botulinum toxin is brought into the presynaptic cell by endocytosis. It acts by blocking the calcium induced release of acetylcholine by selective proteolysis of synaptomal-associated proteins (SNAP)47,48,4,50,51,52,53,54,55. Inhibition of acytelcholine thus causes an inhibition of muscular hyperactivity.

Botulinum toxin has a number of indications approved by the Food and Drug Administration such as the therapeutic treatment for cervical dystonia, cosmetic use such as glabellar lines and wide spectrum of off-label uses such as extracervical spasticities, cerebral palsy, post stroke spasticity, neurologic, dermatologic, and gastrointestinal disorders56. Off-label use of a licensed drug or biologic product occurs with a wide range of products57,58,59.

Objective of the Study We aim to treat TMD of muscular origin using Botulinum toxin injections in the trigger points.

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

入选标准

  • Participant's with trigger points in their masticatory muscles including, but not limited to: masseter and temporalis either bilateral or unilateral and secondly
  • have tried conservative management for at least 3 months and have shown to be refractory to these interventions.

排除标准

  • participant's that do not satisfy the inclusion criteria
  • currently are breastfeeding or pregnant
  • participant's whose TMD is not muscular in origin
  • inability to speak or understand English
  • the inability to provide meaningful informed consent due to physical, cognitive or psychiatric disability
  • a previous known allergy to Botulinum toxin
  • multiple sclerosis
  • pre-existing neuromuscular disorders
  • Lambert-Eaton syndrome
  • chronic centrally mediated neuralgic pain patients.

研究组 & 干预措施

Botulinum Toxin A

Experimental

BTX-A will be reconstituted as directed by the manufacturer. 2.5 mL of diluent (0.9% Saline) per 100 U vial will be used to reconstitute the solution while swirling. This creates a solution with a concentration of 4 U/0.1 mL. Patients will be seated and all usual precautions of sterility and skin preparation will be completed (i.e. alcohol wipes) Injections will be administered unilateral and/or bilaterally in accordance with the topography of the corresponding muscles (temporalis and masseter) into areas of maximal tenderness and pain. Plastic single use insulin syringes with 30 gauge needles will be used to inject 30 U intramuscularly into each masseter, divided evenly into 5 sites and 20 U will be injected into each temporalis, divided evenly over 5 sites. Injections will be completed by the principal investigator and supervisors who will be trained in botulinum toxin injections.

干预措施: Botulinum Toxin Type A (Drug)

结局指标

主要结局

Pain (Visual Analog Scale)

时间窗: 3 months

Subjective pain scores will be assessed on a visual analog scale (VAS) where 0 is no pain and 10 is the worst facial or jaw pain they've ever experience. Subjective functional assessments will also be assessed with VAS where 0 means no limitation and 10 indicates severe limitation with scales for chewing, drinking, exercising, eating hard food, eating soft food, smiling or laughing, cleaning their teeth, yawning, swallowing and talking.

Range of Motion

时间窗: 3 months

Range of motion will be assessed with a Boley gauge between the same upper and lower incisor each time

Palpation tenderness

时间窗: 3 months

Pain to pressure will be ranked from 0 to 5, with 0 indicating no pain and 5 representing extreme debilitating pain. Addition of each score will give a composite score of the overall facial tenderness out of a maximal score of 24 (2 areas X 6 scores X bilaterally).

次要结局

  • Facial Width(3 months)

研究者

申办方类型
Other
责任方
Sponsor

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