We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is not yet open for participant recruitment.
Verified June 2016 by University of Manitoba
Sponsor:
ClinicalTrials.gov Identifier:
NCT02810015
First Posted: June 22, 2016
Last Update Posted: June 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Manitoba
  Purpose
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.

Condition Intervention Phase
Temporo-Myofascial Disorder Drug: Botulinum Toxin Type A Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Temporo-Myofascial Disorder of Muscular Origin Using Botulinum Toxin: A Prospective Study

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Pain (Visual Analog Scale) [ Time Frame: 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 [ Time Frame: 3 months ]
    Range of motion will be assessed with a Boley gauge between the same upper and lower incisor each time

  • Palpation tenderness [ Time Frame: 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).


Secondary Outcome Measures:
  • Facial Width [ Time Frame: 3 months ]
    A point inferior to each ear lobule bilaterally will be marked as well as a point on the menton will be chosen and recorded. The distance unilaterally from one lobule to menton will be measured for left and right sides and a total distance will also be calculated to assess facial width.


Estimated Enrollment: 40
Study Start Date: July 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum Toxin A
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.
Drug: Botulinum Toxin Type A
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810015


Contacts
Contact: Victor Le, DMD 2049143018 victor.le101@gmail.com
Contact: Adnan Shah, DMD 204-963-1962 adnan.shah@umanitoba.ca

Sponsors and Collaborators
University of Manitoba
Investigators
Study Director: Reda Elgazzar, DMD University of Manitoba
  More Information

Publications:
Kaplan AS, Assael LA. Temporomandibular disorders: diagnosis and treatment. Philadelphia (PA): W.B. Saunders Company; 1991. p. 522-5.
Travell JG, Simons DG. Myofascial pain and dysfunction: the trigger point manual. Baltimore (MD):Williams & Wilkins; 1983.
Adler RC, Adachi NY. Physical medicine in the management of myofascial pain and dysfunction: medical management of temporomandibular disorders. Oral Maxillofac Surg Clin North Am 1995;7(1):99-106.
Gangarosa LP, Mahan PE. Pharmacologic management of TMJ-MPDS. Ear Nose Throat J 1982;61:670.
Syrop S. Pharmacologic management of myofascial pain and dysfunction.Oral Maxillofac Surg Clin North Am 1995;7:87-97.
Karlis V, Andreopoulos N, Kinney L, Glickman R. Effectiveness of supervised calibrated exercise therapy on jaw mobility and temporomandibular dysfunction. J Oral Maxillofac Surg 1994;52(8 Suppl 2):147.
Okeson JP. Occlusal appliance therapy. In: Duncan LL, editor. Management of temporomandibular disorders and occlusion. 4th ed. Philadelphia (PA): Mosby Publishing; 1998. p. 474-502.
Bronstein SL, Thomas M. Arthroscopy of the temporomandibular joint. Philadelphia (PA):W.B. Saunders Co.; 1991. p. 320.
Umstadt HE (2002) Botulinum toxin in craniomaxillofacial surgery. Mund Kiefer GesichtsChir 6: 236-240

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02810015     History of Changes
Other Study ID Numbers: B2016:027
First Submitted: June 20, 2016
First Posted: June 22, 2016
Last Update Posted: June 22, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Disease
Pathologic Processes
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents