Original Investigation
Subjective and Objective Outcome Measures in the Treatment of Facial Nerve Synkinesis With OnabotulinumtoxinA (Botox) Steven M. Couch, M.D.*, Rao V. Chundury, M.D., M.B.A.‡, and John B. Holds, M.D., F.A.C.S.†‡§ * Department of Ophthalmology and Visual Sciences, Washington University, St. Louis; †Ophthalmic Plastic and Cosmetic Surgery, Inc., Des Peres; ‡Departments of Ophthalmology, and §Otolaryngology/Head and Neck Surgery, Saint Louis University, St. Louis, Missouri, U.S.A.
Purpose: To evaluate the Sunnybrook Facial Grading System (SFGS) and Facial Clinimetric Evaluation Scale (FaCE Scale) instrument outcome measures pre- and 30-day posttreatment of facial nerve synkinesis with botulinum toxin with attempts to correlate the 2 scales. Methods: An IRB approved retrospective review of 22 patients with facial nerve synkinesis where the surgeon completed the SFGS and the patient completed the FaCE prior to receiving onabotulinumtoxinA therapy, the SFGS, and FaCE scales were completed again 1 month later. Results: Of the 22 patients, 9 complete datasets were analyzed. Mean patient age was 59.8; 8 (89%) women and 1 (11%) men. Overall SFGS composite score decreased from 57.6 ± 20.9 to 45.2 ± 13.5, (p = 0.001). SFGS subdomain synkinesis significantly improved (p < 0.001), while voluntary movement significantly decreased (p = 0.002). A difference in the resting symmetry was not statistically significant (p = 0.08). The FaCE scale composite score significantly improved from 40.9 ± 9.5 to 47.6 ± 11.9, (p = 0.03). FaCE subdomains facial comfort (p = 0.005) and social function (p = 0.009) significantly improved, while oral function, eye comfort, facial movement, and lacrimal control did not. The ∆ pre/post-SFGS composite score did not correlate with the ∆ pre/post-FaCE composite score (rs= −0.318). Subdomain analysis demonstrated significant negative correlation between ∆ pre/post-SFGS synkinesis score and ∆ pre/post-FaCE eye comfort score (rs = −0.826, p < 0.01). Conclusions: Significant improvement was seen in objectively reported synkinesis following botulinum toxin therapy. An improvement was noted in the overall subjective facial nerve functioning following therapy along with improvement in social functioning and facial comfort. A meaningful negative correlation was noted when comparing the SFGS “synkinesis” subdomain with the FaCE scale subdomain “eye comfort”, implying improvement in eye comfort with control of synkinesis. (Ophthal Plast Reconstr Surg 2014;30:246–250)
Accepted for publication November 12, 2013. Supported by Heed Ophthalmological Research Foundation. Dr. Holds serves as a consultant for Merz Pharmaceuticals and Allergan Pharmaceuticals. The authors have no financial or conflicts of interest to disclose. Address correspondence and reprint requests to Steven M. Couch, M.D., Department of Ophthalmology and Visual Sciences, Washington University, 660 South Euclid Ave., Campus Box 8096, St. Louis, MO 63110. E-mail: [email protected] DOI: 10.1097/IOP.0000000000000086
246
F
acial nerve synkinesis refers to an involuntary facial contraction precipitated by a voluntary facial muscle movement and can be one of the most distressing consequences of facial paralysis.1 Thirty percent of patients who experience idiopathic facial palsy regain only partial function and do not fully recover, with synkinesis being one of the more troubling sequelae.2 Three mechanisms are thought are to be responsible for facial nerve synkinesis: aberrant regeneration of facial nerve fibers, and peripheral ephaptic transmission of impulses between axons and synaptic reorganization within the facial nerve nucleus.3 The incidence of postparalysis synkinesis varies but has been reported from 9.1% to 55% in different studies.4–6 Oculo-oral synkinesis is the most commonly occurring synkinetic movement; however, any combination of synkinesis can develop.7 In this situation a winking eyelid with chewing or a unilateral grimace with blinking is seen. These aberrant neuromuscular alterations lead to many physiologic conditions and social problems that are often associated with embarrassment, diminished self-esteem, and poor quality of life.8 The treatment for facial nerve synkinesis initially included surgical options such as selective neurolysis or myectomy.1 Currently, the most common therapeutic modalities for the treatment of facial nerve synkinesis include 1) intramuscular botulinum toxin injections for selective chemodenervation and 2) facial neuromuscular training.1 Onabotulinum toxin A (BOTOX, Allergan, Irvine, CA, U.S.A.) is a Food and Drug Administration approved drug for hemifacial spasms and is commonly used for the treatment of spasms secondary to facial nerve synkinesis. The ability to objectively grade facial nerve function in facial nerve synkinesis is valuable in communicating and documenting the results of any treatment. The Sunnybrook Facial Grading System (SFGS) was first introduced in 1994 by Ross et al.9 (Appendix A). Studies have reported that the SFGS is superior to other scales in sensitivity, comprehensiveness, ease of use, and interobserver reliability.10 Kanerva et al.11 evaluated the repeatability (intrarater reliability) and agreement (interrater reliability) of SFGS and found that SFGS was as good in repeatability as the House-Brackmann Facial Grading system (HBFG) while demonstrating superior agreement between examiners. It has been noted that patients’ overall perceptions of their facial movements were not incorporated in commonly used facial grading systems.12 In 2001, Kahn et al.12 developed and validated a new patient-graded instrument for facial nerve paralysis called the Facial Clinimetric Evaluation Scale (FaCE). The FaCE scale (Appendix B) demonstrated high test–retest reliability and significant correlation with HBFG scores.12 Ophthal Plast Reconstr Surg, Vol. 30, No. 3, 2014
Ophthal Plast Reconstr Surg, Vol. 30, No. 3, 2014
This study evaluates the SFGS and FaCE outcome measures pre- and 30-day posttreatment of facial nerve synkinesis with onabotulinumtoxinA and attempts to correlate the 2 scales.
METHODS This study is an IRB approved retrospective review of records of 22 facial nerve synkinesis patients examined and treated at Ophthalmic Plastic and Cosmetic, Inc., St. Louis, MO, U.S.A., from May 1, 2010, to May 3, 2012. Medical records of all facial nerve synkinesis patients in the authors’ database were carefully reviewed. Treatment protocol of facial nerve synkinesis at Ophthalmic Plastic and Cosmetic, Inc., starting May 1, 2010, involves pre- and post-SFGS and FaCE survey instruments with any patient being treated using onabotulinumtoxinA injections. At 1-month follow up (posttreatment), the clinician completes the SFGS and the patient is asked to mail in a posttreatment FaCE questionnaire. The demographic data, including sex, age, side of onset, number of treatments, and total treatment units, were documented. FaCE composite scores and subdomains were calculated including facial movement (items 1–3), facial comfort (items 4, 6, and 13), oral function (items 11 and 12), eye comfort (items 5 and 7), lacrimal control (item 8), social function (items 9, 10, 14, and 15), and total score (sum of all 15 items). SFGS and FaCE score data are expressed as mean ± SD. SFGS and FaCE composite and subdomain scores were compared, and attempts were made for correlation. The pre- and posttreatment scores were analyzed for differences using paired student t tests, with statistical significance set at p < 0.05. Correlations were determined using Spearman correlation, with coefficients of ≥ 0.40 or ≤−0.40 (p
Subjective and Objective Outcome Measures in the Treatment of Facial Nerve Synkinesis With OnabotulinumtoxinA (Botox) Steven M. Couch, M.D.*, Rao V. Chundury, M.D., M.B.A.‡, and John B. Holds, M.D., F.A.C.S.†‡§ * Department of Ophthalmology and Visual Sciences, Washington University, St. Louis; †Ophthalmic Plastic and Cosmetic Surgery, Inc., Des Peres; ‡Departments of Ophthalmology, and §Otolaryngology/Head and Neck Surgery, Saint Louis University, St. Louis, Missouri, U.S.A.
Purpose: To evaluate the Sunnybrook Facial Grading System (SFGS) and Facial Clinimetric Evaluation Scale (FaCE Scale) instrument outcome measures pre- and 30-day posttreatment of facial nerve synkinesis with botulinum toxin with attempts to correlate the 2 scales. Methods: An IRB approved retrospective review of 22 patients with facial nerve synkinesis where the surgeon completed the SFGS and the patient completed the FaCE prior to receiving onabotulinumtoxinA therapy, the SFGS, and FaCE scales were completed again 1 month later. Results: Of the 22 patients, 9 complete datasets were analyzed. Mean patient age was 59.8; 8 (89%) women and 1 (11%) men. Overall SFGS composite score decreased from 57.6 ± 20.9 to 45.2 ± 13.5, (p = 0.001). SFGS subdomain synkinesis significantly improved (p < 0.001), while voluntary movement significantly decreased (p = 0.002). A difference in the resting symmetry was not statistically significant (p = 0.08). The FaCE scale composite score significantly improved from 40.9 ± 9.5 to 47.6 ± 11.9, (p = 0.03). FaCE subdomains facial comfort (p = 0.005) and social function (p = 0.009) significantly improved, while oral function, eye comfort, facial movement, and lacrimal control did not. The ∆ pre/post-SFGS composite score did not correlate with the ∆ pre/post-FaCE composite score (rs= −0.318). Subdomain analysis demonstrated significant negative correlation between ∆ pre/post-SFGS synkinesis score and ∆ pre/post-FaCE eye comfort score (rs = −0.826, p < 0.01). Conclusions: Significant improvement was seen in objectively reported synkinesis following botulinum toxin therapy. An improvement was noted in the overall subjective facial nerve functioning following therapy along with improvement in social functioning and facial comfort. A meaningful negative correlation was noted when comparing the SFGS “synkinesis” subdomain with the FaCE scale subdomain “eye comfort”, implying improvement in eye comfort with control of synkinesis. (Ophthal Plast Reconstr Surg 2014;30:246–250)
Accepted for publication November 12, 2013. Supported by Heed Ophthalmological Research Foundation. Dr. Holds serves as a consultant for Merz Pharmaceuticals and Allergan Pharmaceuticals. The authors have no financial or conflicts of interest to disclose. Address correspondence and reprint requests to Steven M. Couch, M.D., Department of Ophthalmology and Visual Sciences, Washington University, 660 South Euclid Ave., Campus Box 8096, St. Louis, MO 63110. E-mail: [email protected] DOI: 10.1097/IOP.0000000000000086
246
F
acial nerve synkinesis refers to an involuntary facial contraction precipitated by a voluntary facial muscle movement and can be one of the most distressing consequences of facial paralysis.1 Thirty percent of patients who experience idiopathic facial palsy regain only partial function and do not fully recover, with synkinesis being one of the more troubling sequelae.2 Three mechanisms are thought are to be responsible for facial nerve synkinesis: aberrant regeneration of facial nerve fibers, and peripheral ephaptic transmission of impulses between axons and synaptic reorganization within the facial nerve nucleus.3 The incidence of postparalysis synkinesis varies but has been reported from 9.1% to 55% in different studies.4–6 Oculo-oral synkinesis is the most commonly occurring synkinetic movement; however, any combination of synkinesis can develop.7 In this situation a winking eyelid with chewing or a unilateral grimace with blinking is seen. These aberrant neuromuscular alterations lead to many physiologic conditions and social problems that are often associated with embarrassment, diminished self-esteem, and poor quality of life.8 The treatment for facial nerve synkinesis initially included surgical options such as selective neurolysis or myectomy.1 Currently, the most common therapeutic modalities for the treatment of facial nerve synkinesis include 1) intramuscular botulinum toxin injections for selective chemodenervation and 2) facial neuromuscular training.1 Onabotulinum toxin A (BOTOX, Allergan, Irvine, CA, U.S.A.) is a Food and Drug Administration approved drug for hemifacial spasms and is commonly used for the treatment of spasms secondary to facial nerve synkinesis. The ability to objectively grade facial nerve function in facial nerve synkinesis is valuable in communicating and documenting the results of any treatment. The Sunnybrook Facial Grading System (SFGS) was first introduced in 1994 by Ross et al.9 (Appendix A). Studies have reported that the SFGS is superior to other scales in sensitivity, comprehensiveness, ease of use, and interobserver reliability.10 Kanerva et al.11 evaluated the repeatability (intrarater reliability) and agreement (interrater reliability) of SFGS and found that SFGS was as good in repeatability as the House-Brackmann Facial Grading system (HBFG) while demonstrating superior agreement between examiners. It has been noted that patients’ overall perceptions of their facial movements were not incorporated in commonly used facial grading systems.12 In 2001, Kahn et al.12 developed and validated a new patient-graded instrument for facial nerve paralysis called the Facial Clinimetric Evaluation Scale (FaCE). The FaCE scale (Appendix B) demonstrated high test–retest reliability and significant correlation with HBFG scores.12 Ophthal Plast Reconstr Surg, Vol. 30, No. 3, 2014
Ophthal Plast Reconstr Surg, Vol. 30, No. 3, 2014
This study evaluates the SFGS and FaCE outcome measures pre- and 30-day posttreatment of facial nerve synkinesis with onabotulinumtoxinA and attempts to correlate the 2 scales.
METHODS This study is an IRB approved retrospective review of records of 22 facial nerve synkinesis patients examined and treated at Ophthalmic Plastic and Cosmetic, Inc., St. Louis, MO, U.S.A., from May 1, 2010, to May 3, 2012. Medical records of all facial nerve synkinesis patients in the authors’ database were carefully reviewed. Treatment protocol of facial nerve synkinesis at Ophthalmic Plastic and Cosmetic, Inc., starting May 1, 2010, involves pre- and post-SFGS and FaCE survey instruments with any patient being treated using onabotulinumtoxinA injections. At 1-month follow up (posttreatment), the clinician completes the SFGS and the patient is asked to mail in a posttreatment FaCE questionnaire. The demographic data, including sex, age, side of onset, number of treatments, and total treatment units, were documented. FaCE composite scores and subdomains were calculated including facial movement (items 1–3), facial comfort (items 4, 6, and 13), oral function (items 11 and 12), eye comfort (items 5 and 7), lacrimal control (item 8), social function (items 9, 10, 14, and 15), and total score (sum of all 15 items). SFGS and FaCE score data are expressed as mean ± SD. SFGS and FaCE composite and subdomain scores were compared, and attempts were made for correlation. The pre- and posttreatment scores were analyzed for differences using paired student t tests, with statistical significance set at p < 0.05. Correlations were determined using Spearman correlation, with coefficients of ≥ 0.40 or ≤−0.40 (p
