Face Pain
Conditions
Keywords
Bruxism, Myofascial pain, EMG, Ultrasound, Masticatory myofascial face pain from bruxism and clenching
Brief summary
Botulinum toxin-A (BTX-A) prevents the release of acetylcholine in presynaptic terminals of the neuromuscular junction. It has been proposed to be effective in spastic conditions of the head and neck including oromandibular dystonias, bruxism, and muscular hypertrophy (1,2,3,4). However, only one randomized, double-blinded, placebo controlled trial has been completed involving 20 patients demonstrating both objective and subjective improvement in the BTX-A treated group over those treated with saline at one week, one month, and six months (5). Currently, in most orofacial pain practices, when the diagnosis of masticatory myofascial pain in the head region is made, patients are treated with a standard myofascial protocol. This protocol involves stretching, application of moist heat, spray and stretch, and lidocaine trigger point injections into the masticatory muscles. This is considered the standard of care among most orofacial pain practioners. There have been no randomized, double-blinded, head-to-head trials comparing BTX-A injections to lidocaine injections in the treatment of masticatory myofacial pain. Moreover, in all studies, muscles were targeted using surface landmarks with no confirmatory tests to guarantee the medication was administered to the intended muscle. In previous studies, the medial and lateral pterygoid muscles, important masticatory muscles that is often hyperactive in masticatory myofacial pain was not injected due to lack of palpable surface landmarks. Ultrasound and electromyography (EMG) guidance will help us locate these muscles. The purpose of this study is to objectively measure functional improvement in patients with masticatory myofascial pain injected with lidocaine versus BTX-A. A pilot study enrolling 20 patients is proposed. 20 patients will be randomized to receive either BTX-A or lidocaine injections into the bilateral temporalis, masseter, and medial and lateral pterygoid. Objective and subjective clinical parameters will be measured. These include pain at rest and with chewing, maximum non-assisted and assisted mouth opening, protrusive and laterotrusive jaw movements, subjective efficacy of treatment, and side-effects of treatment. Patients will be assessed at baseline, one week, one month, and three months after the procedure.
Interventions
DRUGlidocaine
1cc 1%
DRUGchemodenervation
botulinum toxin
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects are to have identifiable painful myofascial trigger points in the masseter, temporalis, and medial and lateral pterygoid muscles. * Subjects will be examined by the principle investigators to determine if the individual is a suitable candidate for the study, based on active trigger points and willingness to participate in the study
Exclusion criteria
* Pregnant woman will be excluded from participation as potential risk is noted in product label indications. Individuals over the age of 65 will be excluded per product label indications that reflect lack of data in individuals over age 65.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score | 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score | 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. |
| Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold | baseline, 4 months | 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). |
| Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening | baseline, 4 months | maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine lidocaine injection group
lidocaine: 1cc 1% | 7 |
| Botulinum chemodenervation: botulinum toxin | 10 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Lidocaine | Botulinum | Total |
|---|---|---|---|
| Age, Continuous | 57.14 years | 44.7 years | 49.82 years |
| Gender Female | 6 Participants | 8 Participants | 14 Participants |
| Gender Male | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 7 participants | 10 participants | 17 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 7 | 2 / 10 |
| serious Total, serious adverse events | 0 / 7 | 0 / 10 |
Outcome results
Primary
Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score
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
Population: participants who completed the 4-month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine | Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score | 5 participants |
| Botulinum | Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score | 7 participants |
Secondary
Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening
maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion)
Time frame: baseline, 4 months
Population: Participants completing the 4-month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine | Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening | 2 participants |
| Botulinum | Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening | 0 participants |
Secondary
Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine | Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score | 5 participants |
| Botulinum | Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score | 6 participants |
Secondary
Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold
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
Population: Participants completing the 4-month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine | Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold | 3 participants |
| Botulinum | Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold | 4 participants |