Trial Outcomes & Findings for Efficacy of Botulinum Toxin Versus Lidocaine in Treating Masticatory Myofascial Face Pain Using Ultrasound and EMG Guided Techniques (NCT NCT00992108)

Results Overview

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."

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

4 months

Results posted on

2016-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	Lidocaine lidocaine injection group lidocaine: 1cc 1%	Botulinum chemodenervation: botulinum toxin
Overall Study STARTED	7	10
Overall Study COMPLETED	7	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Lidocaine lidocaine injection group lidocaine: 1cc 1%	Botulinum chemodenervation: botulinum toxin
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine n=7 Participants lidocaine injection group lidocaine: 1cc 1%	Botulinum n=10 Participants chemodenervation: botulinum toxin	Total n=17 Participants Total of all reporting groups
Age, Continuous	57.14 years n=5 Participants	44.7 years n=7 Participants	49.82 years n=5 Participants
Gender Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	10 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Population: participants who completed the 4-month follow-up

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."

Outcome measures

Outcome measures
Measure	Lidocaine n=7 Participants lidocaine injection group lidocaine: 1cc 1%	Botulinum n=9 Participants chemodenervation: botulinum toxin
Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score	5 participants	7 participants

SECONDARY outcome

Timeframe: 6 weeks

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."

Outcome measures

Outcome measures
Measure	Lidocaine n=7 Participants lidocaine injection group lidocaine: 1cc 1%	Botulinum n=10 Participants chemodenervation: botulinum toxin
Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score	5 participants	6 participants

SECONDARY outcome

Timeframe: baseline, 4 months

Population: Participants completing the 4-month follow-up

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).

Outcome measures

Outcome measures
Measure	Lidocaine n=7 Participants lidocaine injection group lidocaine: 1cc 1%	Botulinum n=9 Participants chemodenervation: botulinum toxin
Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold	3 participants	4 participants

SECONDARY outcome

Timeframe: baseline, 4 months

Population: Participants completing the 4-month follow-up

maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion)

Outcome measures

Outcome measures
Measure	Lidocaine n=7 Participants lidocaine injection group lidocaine: 1cc 1%	Botulinum n=9 Participants chemodenervation: botulinum toxin
Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening	2 participants	0 participants

Adverse Events

Lidocaine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Botulinum

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lidocaine n=7 participants at risk lidocaine injection group lidocaine: 1cc 1%	Botulinum n=10 participants at risk chemodenervation: botulinum toxin
General disorders Headache	14.3% 1/7 • Number of events 1 • 4 months	10.0% 1/10 • Number of events 1 • 4 months
Musculoskeletal and connective tissue disorders facial muscle weakness	0.00% 0/7 • 4 months	10.0% 1/10 • Number of events 1 • 4 months

Additional Information

Marisa Chang, MD

UCLA Neurology

Phone: 310-794-1870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place