Bell Palsy
Conditions
Keywords
Facial Paralysis, Bell Palsy, Electrical Stimulation
Brief summary
A feasibility pilot study to exam the necessary methodology for conducting a larger clinical trial for Bell's Palsy patients with a poor prognosis and the use of electrical stimulation.
Detailed description
Here we describe a protocol for a prospective, randomized, double-blinded study to evaluate the effects of monophasic pulsed current ES on patients with Bell's palsy and factors predicting poor recovery, with a 6 month follow up. Motor level stimulation with a pulse duration of 100 μsec and a frequency of 35 pulses per second were chosen from focus group with physical therapist to treat facial paralysis and are consistent with clinical trials showing motor benefit after capel tunnel surgery.
Interventions
DEVICEElectrical stimulation device (tens unit)
An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigator and outcome assessors are blinded to the intervention. The physical therapist that teaches the research subjects how to perform the interventions are not blinded and patients are told they are assigned to either sensory or subsensory protocols.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New diagnosis of bell's palsy (diagnosed in the last 30 days) * IF younger than 60 years of age must have complete paralysis on one side of face or both * IF older than 60 years of age paralysis must be present but CAN be incomplete.
Exclusion criteria
* Paralysis associated with any of the fallowing: cancer, tumor, surgery, stroke, or trauma. * Younger than 60 years old with INCOMPLETE paralysis. * Non English speakers * Pacemaker or deep brain stimulator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions | 3 months | To evaluate for complete recovery, standardized photos of patients at rest, and during movement, will be evaluated by three treatment-blinded otolaryngologists. Total number of patients fully recovered over number of participants will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ) | Baseline, 3 months and 6 months | Quality of life is in part measured in this study using the patient reported Synkinesis Assessment Questionnaire (SAQ). The instrument consisting of 10 items asks participants how difficult certain facial activities are. Based on the average score for each domain the test gives a score between 20 (no synkinesis) to 100 (severe synkinesis, all the time). |
| Patient Reported Global Quality of Life Specific to Facial Paralysis | Baseline, 3 months and 6 months | Measured by the validated quality of life patient reported questionnaire Facial Clinimetric Evaluation (FaCE) Scale with a scale from 0 (normal) to 100 (severe dysfunction). The scale encompasses facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function. |
| Objective Measurements of Brow Elevation | Baseline and in 3 months | Measuring brow elevation using the MEEI FACE-gram program reported as the millimeters in decreased elevation in comparison to the unaffected side |
| Eye Closure | Baseline and 3 months | Measuring in millimeters of the eyelids remaining open during maximal eye closure using the MEEI FACE-gram program |
| House Brackmann Scale | Baseline, and 3 months | Determined by three blinded otolaryngologist reviewing facial photos of patients with smile and eye closure. Reported as an average of the three scores. The scales ranges from 1 (normal) to 6 (most severe dysfunction) |
| Facial Symmetry at Rest | Baseline and 3 months | Measured by facial asymmetry index (FAI) at rest in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals no difference between sides and perfect symmetry. The closer a number is to 0, the higher the symmetry is. Ranges have not been published for this scale. FAI does not have a maximum score. |
| Facial Symmetry During Smile | Baseline and 3 months | Measured by facial asymmetry index (FAI) during smile in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals perfect symmetry and no difference in sides. The closer a number is to 0, the greater the symmetry. Ranges have not been published for this scale. FAI does not have a maximum score. |
| Patient Tolerability | 3 months | Measured by a visual analog scale (VAS) which ranged from 0 to 10 where 0 stands for completely comfortable and 10 to very uncomfortable. A questionnaire designed by research team using a Likert's scale was created to measure patient tolerability. |
| Self Reported Subject Adherence | 3 months | Percentage of subjected who reported full adherence, partial adherence and non-adherence confirmed by comparing to the daily diary of use. |
| Smile Excursion | Baseline and 3 months | Measuring oral commissure exclusion using the MEEI FACE-gram program reported as the change in millimeters in the distance between the midline of the lower lip and the oral commissure in comparison between rest and smile |
Countries
United States
Participant flow
Pre-assignment details
Blocks were designed to account for predictors of recovery. There were four allocation blocks: 1) \>60 age with complete paralysis, 2) \> 60 age with incomplete paralysis, 3) \<60 age with complete paralysis and \< 15 days duration, or 4) \<60 age with complete paralysis and \>15 days duration. The block size was 2 and the allocation was 1:1. All patients were randomly allocated to high-volt arm
Participants by arm
| Arm | Count |
|---|---|
| High-volt Electrical Stimulation Plan to use a monophasic waveform having 100µmsec pulse duration, at 35 Hz using tolerated voltage to generate a contraction a total of 20 minutes.
The stimulation will have 10 seconds on time, 30 seconds off time and 2 second ramp up and down. Electrical stimulation will be produced with the Orthostim 3 device (VQ Ortho Care). The cathode will be placed on the ipsilateral muscle to stimulate and the anode over the ipsilateral mastoid region.
Four facial muscles will be stimulated: 1)frontalis, 2) orbicularis oculi, 3) zygomaticus major, and 4) orbicularis oris.
The voltage is turned up by the participant until he or she can see twitches or as high as tolerated. Ten contractions in each muscle group will be performed or 5 minutes per muscle if no contraction is achieved | 4 |
| Subsensory Electrical Stimulation Plan to use the same device and settings to provide placebo treatment by delivering minimal electricity. The settings will be the same as the intervention except the voltage will be subsensory. ie. below the minimum at which patients feels any effect of the current.
The voltage is turned down two clicks from the voltage at which the participant can first notice any electricity or at the minimal setting. | 0 |
| Total | 4 |
Baseline characteristics
| Characteristic | Total | High-volt Electrical Stimulation |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — |
| Region of Enrollment United States | 4 Participants | 4 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 0 |
| other Total, other adverse events | 3 / 4 | 0 / 0 |
| serious Total, serious adverse events | 0 / 4 | 0 / 0 |
Outcome results
Primary
Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions
To evaluate for complete recovery, standardized photos of patients at rest, and during movement, will be evaluated by three treatment-blinded otolaryngologists. Total number of patients fully recovered over number of participants will be reported.
Time frame: 3 months
Population: Randomization led to no Subsensory participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-volt Electrical Stimulation | Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions | 3 Participants |
Secondary
Eye Closure
Measuring in millimeters of the eyelids remaining open during maximal eye closure using the MEEI FACE-gram program
Time frame: Baseline and 3 months
Population: No subjects were allocated to the subsensory arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-volt Electrical Stimulation | Eye Closure | Baseline | 2.5 millimeters | Standard Deviation 3.1 |
| High-volt Electrical Stimulation | Eye Closure | 3 months | 0.5 millimeters | Standard Deviation 0.6 |
Secondary
Facial Symmetry at Rest
Measured by facial asymmetry index (FAI) at rest in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals no difference between sides and perfect symmetry. The closer a number is to 0, the higher the symmetry is. Ranges have not been published for this scale. FAI does not have a maximum score.
Time frame: Baseline and 3 months
Population: No subjects were allocated to the subsensory arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-volt Electrical Stimulation | Facial Symmetry at Rest | Baseline | 0.25 score on a scale | Standard Deviation 0.2 |
| High-volt Electrical Stimulation | Facial Symmetry at Rest | 3 months | 0.02 score on a scale | Standard Deviation 0 |
Secondary
Facial Symmetry During Smile
Measured by facial asymmetry index (FAI) during smile in photos which is calculated as the difference in the distance from the lateral canthus to the oral commissure between the affected and unaffected side. In the scale 0 equals perfect symmetry and no difference in sides. The closer a number is to 0, the greater the symmetry. Ranges have not been published for this scale. FAI does not have a maximum score.
Time frame: Baseline and 3 months
Population: no subjects were allocated to the subsensory arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-volt Electrical Stimulation | Facial Symmetry During Smile | Baseline | 0.4 score on a scale | Standard Deviation 0.6 |
| High-volt Electrical Stimulation | Facial Symmetry During Smile | 3 months | 0.2 score on a scale | Standard Deviation 0.19 |
Secondary
House Brackmann Scale
Determined by three blinded otolaryngologist reviewing facial photos of patients with smile and eye closure. Reported as an average of the three scores. The scales ranges from 1 (normal) to 6 (most severe dysfunction)
Time frame: Baseline, and 3 months
Population: No subjects underwent subsensory electrical stimulation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-volt Electrical Stimulation | House Brackmann Scale | 3 months | 2 score on a scale | Standard Deviation 1.15 |
| High-volt Electrical Stimulation | House Brackmann Scale | Baseline | 5.5 score on a scale | Standard Deviation 1 |
Secondary
Objective Measurements of Brow Elevation
Measuring brow elevation using the MEEI FACE-gram program reported as the millimeters in decreased elevation in comparison to the unaffected side
Time frame: Baseline and in 3 months
Population: No subjects were allocated to the subsensory arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-volt Electrical Stimulation | Objective Measurements of Brow Elevation | Baseline | 7.75 millimeters | Standard Deviation 2.2 |
| High-volt Electrical Stimulation | Objective Measurements of Brow Elevation | 3 months | 4.5 millimeters | Standard Deviation 5.2 |
Secondary
Patient Reported Global Quality of Life Specific to Facial Paralysis
Measured by the validated quality of life patient reported questionnaire Facial Clinimetric Evaluation (FaCE) Scale with a scale from 0 (normal) to 100 (severe dysfunction). The scale encompasses facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function.
Time frame: Baseline, 3 months and 6 months
Population: No subjects were recruited for the subsensory arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-volt Electrical Stimulation | Patient Reported Global Quality of Life Specific to Facial Paralysis | Baseline | 37.5 score on a scale | Standard Deviation 3.4 |
| High-volt Electrical Stimulation | Patient Reported Global Quality of Life Specific to Facial Paralysis | 3 months | 51.25 score on a scale | Standard Deviation 12.03 |
| High-volt Electrical Stimulation | Patient Reported Global Quality of Life Specific to Facial Paralysis | 6 months | 51 score on a scale | Standard Deviation 15 |
Secondary
Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ)
Quality of life is in part measured in this study using the patient reported Synkinesis Assessment Questionnaire (SAQ). The instrument consisting of 10 items asks participants how difficult certain facial activities are. Based on the average score for each domain the test gives a score between 20 (no synkinesis) to 100 (severe synkinesis, all the time).
Time frame: Baseline, 3 months and 6 months
Population: No research subjects participated in the subsensory electrical stimulation arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-volt Electrical Stimulation | Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ) | 3 month outcome | 27.5 score on a scale | Standard Deviation 5.25 |
| High-volt Electrical Stimulation | Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ) | 6 month outcome | 38.7 score on a scale | Standard Deviation 23.5 |
| High-volt Electrical Stimulation | Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ) | Baseline | 31 score on a scale | Standard Deviation 7.7 |
Secondary
Patient Tolerability
Measured by a visual analog scale (VAS) which ranged from 0 to 10 where 0 stands for completely comfortable and 10 to very uncomfortable. A questionnaire designed by research team using a Likert's scale was created to measure patient tolerability.
Time frame: 3 months
Population: No subjected were recruited for the subsensory arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-volt Electrical Stimulation | Patient Tolerability | 2.7 score on a scale | Standard Deviation 2.3 |
Secondary
Self Reported Subject Adherence
Percentage of subjected who reported full adherence, partial adherence and non-adherence confirmed by comparing to the daily diary of use.
Time frame: 3 months
Population: no subjects were recruited to the subsensory electrical stimulation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-volt Electrical Stimulation | Self Reported Subject Adherence | Non adherence | 0 Participants |
| High-volt Electrical Stimulation | Self Reported Subject Adherence | Full adherence | 4 Participants |
| High-volt Electrical Stimulation | Self Reported Subject Adherence | Partial adherence | 0 Participants |
Secondary
Smile Excursion
Measuring oral commissure exclusion using the MEEI FACE-gram program reported as the change in millimeters in the distance between the midline of the lower lip and the oral commissure in comparison between rest and smile
Time frame: Baseline and 3 months
Population: No subjects were allocated to the subsensory arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-volt Electrical Stimulation | Smile Excursion | Baseline | -1 millimeters | Standard Deviation 1.15 |
| High-volt Electrical Stimulation | Smile Excursion | 3 months | 4.5 millimeters | Standard Deviation 3.5 |