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Efficacy of Botulinum Toxin Versus Lidocaine in Treating Masticatory Myofascial Face Pain Using Ultrasound and EMG Guided Techniques

This study has been terminated.
(Lack of eligible patients willing and able to participate)
Sponsor:
Information provided by (Responsible Party):
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00992108
First received: October 8, 2009
Last updated: November 2, 2016
Last verified: November 2016
Results First Received: August 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Face Pain
Interventions: Drug: lidocaine
Drug: chemodenervation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lidocaine

lidocaine injection group

lidocaine: 1cc 1%

Botulinum chemodenervation: botulinum toxin

Participant Flow:   Overall Study
    Lidocaine   Botulinum
STARTED   7   10 
COMPLETED   7   9 
NOT COMPLETED   0   1 
Lost to Follow-up                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Lidocaine

lidocaine injection group

lidocaine: 1cc 1%

Botulinum chemodenervation: botulinum toxin
Total Total of all reporting groups

Baseline Measures
   Lidocaine   Botulinum   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   10   17 
Age 
[Units: Years]
Mean (Full Range)
 57.14 
 (38 to 76) 
 44.7 
 (24 to 65) 
 49.82 
 (24 to 76) 
Gender 
[Units: Participants]
Count of Participants
     
Female      6  85.7%      8  80.0%      14  82.4% 
Male      1  14.3%      2  20.0%      3  17.6% 
Region of Enrollment 
[Units: Participants]
     
United States   7   10   17 


  Outcome Measures
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1.  Primary:   Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score   [ Time Frame: 4 months ]

2.  Secondary:   Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score   [ Time Frame: 6 weeks ]

3.  Secondary:   Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold   [ Time Frame: baseline, 4 months ]

4.  Secondary:   Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening   [ Time Frame: baseline, 4 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Marisa Chang, MD
Organization: UCLA Neurology
phone: 310-794-1870
e-mail: marisachang@mednet.ucla.edu



Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00992108     History of Changes
Other Study ID Numbers: 8295968
Study First Received: October 8, 2009
Results First Received: August 29, 2016
Last Updated: November 2, 2016