The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive 100 units of reconstituted botulinum toxin A. 37.5 units will be injected into each masseter muscle and 12.5 units into each temporalis muscle. A written post-operative instruction sheet will be provided to all patients.

The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive unpreserved 0.9% sodium chloride. A written post-operative instruction sheet will be provided to all patients.

Pain, Head

Pain Syndrome

Temporomandibular Disorder

Myofascial Pain Syndrome

Myofascial Pain

37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle

Botulinum toxin type A

0.9% Sodium Chloride Injection

University of Illinois at Chicago

Weill Cornell Medical College - NewYork-Presbyterian Hospital

Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles

Comparison of Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles in the Management of Myofascial Pain Disorder: A Randomized Clinical Trial

Visual Analog Scale ranging from "no pain" to "pain as bad as it could possibly be"

A series of yes or no questions to determine what activities a patient's jaw problem prevents or limits them from doing. A high score of 7 indicates severe jaw limitation, a low score of 0 indicates no jaw limitation.

Mouth opening measurements in mm both when patient is in pain and not in pain. This measurement is taken from the maxillary central incisor to mandibular central incisor.

Short Form 36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are utilized for routine monitoring and assessment of care outcomes in adult patients. A high score of 100 on this survey indicates the patient is self-reporting a high quality-of-life, a low score of 0 indicates a low quality-of-life.

Weill Medical College of Cornell University

New York Presbyterian Hospital

Allergan

Study participants will be randomly allocated to one of two treatment arms (injection of botulinum versus placebo). Blocked randomization will be performed at each of the participating sites. They will be stratified based on study site.

Randomization will be carried out by the biostatistics team at Weill Cornell. This will provide assurance that there will be equal patient allocation to both study arms, at each participating site, in the event that the target sample size is not reached. The list will be maintained by the investigational pharmacy. A designated research assistant will be identified at each site to prepare the interventional medication (botulinum versus normal saline). The identity of the agent injected will be unknown to the surgeon as the agent will be drawn up by an assistant in a masked syringe immediately prior to each procedure and labeled with the patient's identifier. Only one assistant at each site will know the identity of the agents during the trial.

dystonia/кариес

Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles

Measurement of Risperidone and 9-Hydroxyrisperidone in Plasma and Saliva

Най-пълната база данни за лечебни билки, подкрепена от науката