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

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ClinicalTrials.gov Identifier: NCT00992108
Recruitment Status : Terminated (Lack of eligible patients willing and able to participate)
First Posted : October 9, 2009
Results First Posted : December 29, 2016
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Face Pain
Interventions Drug: lidocaine
Drug: chemodenervation
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lidocaine Botulinum
Hide Arm/Group Description

lidocaine injection group

lidocaine: 1cc 1%

chemodenervation: botulinum toxin
Period Title: Overall Study
Started 7 10
Completed 7 9
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Lidocaine Botulinum Total
Hide Arm/Group Description

lidocaine injection group

lidocaine: 1cc 1%

chemodenervation: botulinum toxin Total of all reporting groups
Overall Number of Baseline Participants 7 10 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 10 participants 17 participants
57.14
(38 to 76)
44.7
(24 to 65)
49.82
(24 to 76)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
Female
6
  85.7%
8
  80.0%
14
  82.4%
Male
1
  14.3%
2
  20.0%
3
  17.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 10 participants 17 participants
7 10 17
1.Primary Outcome
Title Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score
Hide Description The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = "no limitation" and 10 = "severe limitation."
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
participants who completed the 4-month follow-up
Arm/Group Title Lidocaine Botulinum
Hide Arm/Group Description:

lidocaine injection group

lidocaine: 1cc 1%

chemodenervation: botulinum toxin
Overall Number of Participants Analyzed 7 9
Measure Type: Number
Unit of Measure: participants
5 7
2.Secondary Outcome
Title Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score
Hide Description The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = "no limitation" and 10 = "severe limitation."
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Botulinum
Hide Arm/Group Description:

lidocaine injection group

lidocaine: 1cc 1%

chemodenervation: botulinum toxin
Overall Number of Participants Analyzed 7 10
Measure Type: Number
Unit of Measure: participants
5 6
3.Secondary Outcome
Title Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold
Hide Description measurements were obtained by placing examiner’s index finger of the examiner on the area of the trigger point (hyperirritable areas on skeletal muscle with palpable taut bands of muscle fibers) and exerting pressure until there was whitening of the nail bed. Pressure pain levels were rated subjectively by the participant and coded numerically as mild (1), moderate (2) to severe (3).
Time Frame baseline, 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing the 4-month follow-up
Arm/Group Title Lidocaine Botulinum
Hide Arm/Group Description:

lidocaine injection group

lidocaine: 1cc 1%

chemodenervation: botulinum toxin
Overall Number of Participants Analyzed 7 9
Measure Type: Number
Unit of Measure: participants
3 4
4.Secondary Outcome
Title Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening
Hide Description maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion)
Time Frame baseline, 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing the 4-month follow-up
Arm/Group Title Lidocaine Botulinum
Hide Arm/Group Description:

lidocaine injection group

lidocaine: 1cc 1%

chemodenervation: botulinum toxin
Overall Number of Participants Analyzed 7 9
Measure Type: Number
Unit of Measure: participants
2 0
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lidocaine Botulinum
Hide Arm/Group Description

lidocaine injection group

lidocaine: 1cc 1%

chemodenervation: botulinum toxin
All-Cause Mortality
Lidocaine Botulinum
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lidocaine Botulinum
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lidocaine Botulinum
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      2/10 (20.00%)    
General disorders     
Headache   1/7 (14.29%)  1 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders     
facial muscle weakness   0/7 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
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
Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00992108     History of Changes
Other Study ID Numbers: 8295968
First Submitted: October 8, 2009
First Posted: October 9, 2009
Results First Submitted: August 29, 2016
Results First Posted: December 29, 2016
Last Update Posted: December 29, 2016