Greater Manchester EUR Policy Statement. Title/Topic: Trophic Electrical Stimulation (TES) for Facial Palsy Reference: GM005 Date: May 2016

Transcription

1 Greater Manchester EUR Policy Statement Title/Topic: Trophic Electrical Stimulation (TES) for Facial Palsy Reference: GM005 Date: May 2016

2 VERSION CONTROL Version Date Details Page number /12/2014 Initial draft N/A /01/2015 Amendments made after GM EUR Steering Group on 21/01/2015: Section 4 Criteria for Commissioning: Bullet point under mandatory criteria added difficulty with facial expressions sufficient to interfere with non-verbal communication Section 9 Mechanism for Funding: funding mechanism amended to prior approval for assessment and subsequent treatment plan via clinical triage or relevant IFR Panel /7/2015 Changes requested by the GM EUR Steering Group on the 8 th July 2015:- Section 4 Mandatory Criteria 4 &10 Clarity added around what treatment should have been tried in the 6 months prior to requesting an assessment for chronic idiopathic facial palsy. Clarity added around what evidence should be provided in support of requests for cases of nerve damage. Section 9 Funding Mechanism - reworded for clarity to read:- 4 & 12 Funding for the initial assessment will be via prior approval from the North West Commissioning Support Unit IFR Team. Requests for an assessment will be approved or declined at screening in line with the mandatory criteria by the EUR team. On receipt of the assessment report from the provider (or if the initial application includes an assessment report) cases can be approved or declined by clinical triage in line with the mandatory criteria. Any requests requiring further discussion will be sent onto CCG Panels for consideration. Any requests for an extension of funding will be reviewed by triage but must be accompanied by a detailed progress report that includes the expected outcome from the extended treatment. Any requests requiring further discussion will be sent onto CCG Panels for consideration. For all other cases if they are felt to be exceptional, funding may be made requested on an individual patient basis from the North West Commissioning Support Unit IFR Team. Subject to the above changes being made the GM EUR Steering Group agreed the policy could go through the governance process. GM TES for Facial Palsy Policy v1.2 FINAL Page 2 of 17

3 1.1 20/01/ /03/2016 Following GM EUR Steering Group on 20/01/2016 the wording for date of review changed to read as follows:- One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group. (Unless stated this will be every 2 years). Policy updated to Greater Manchester Shared Services template and references to North West Commissioning Support Unit changed to Greater Manchester Shared Services. 4 & 13 N/A /07/2016 GM EUR Steering Group agreed the following change for clarity to the policy:- 4 & 9 Under Mandatory Criteria following words add after AND in all cases there must be demonstrable functional problems associated with the palsy GM TES for Facial Palsy Policy v1.2 FINAL Page 3 of 17

4 POLICY STATEMENT Title/Topic: Trophic Electrical Stimulation (TES) for Facial Palsy Issue Date: May 2016 Commissioning Recommendation: Mandatory Criteria Trophic electrical stimulation (TES) is commissioned for: OR Chronic idiopathic facial palsy (Bell s palsy) which has not responded to treatment in 6 months or for cases of recurrent idiopathic facial palsy (Bell s palsy) Cases of nerve damage where the specialist managing the case has provided evidence in support of referral for trophic electrical stimulation AND in all cases there must be demonstrable functional problems associated with the palsy, including but not restricted to: o difficulty closing the eye o difficulty articulating speech o difficulty in eating and drinking o difficulty with facial expressions sufficient to interfere with nonverbal communication See Section 4: Criteria for Commissioning Date of Review: One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group (Unless stated this will be every 2 years) Prepared By: Greater Manchester Shared Services Effective Use of Resources Policy Team Approved By Date Approved Funding Mechanism Greater Manchester Effective Use of Resources Steering Group 08/07/2015 GM EUR Steering Group recommended funding mechanism: Funding for the initial assessment will be via prior approval from the Greater Manchester Shared Services IFR Team. Requests for an assessment will be approved or declined at screening in line with the mandatory criteria by the EUR team. GM TES for Facial Palsy Policy v1.2 FINAL Page 4 of 17

5 On receipt of the assessment report from the provider (or if the initial application includes an assessment report) cases can be approved or declined by clinical triage in line with the mandatory criteria. Any requests requiring further discussion will be sent onto CCG Panels for consideration. Any requests for an extension of funding will be reviewed by triage but must be accompanied by a detailed progress report that includes the expected outcome from the extended treatment. Any requests requiring further discussion will be sent onto CCG Panels for consideration. For all other cases if they are felt to be exceptional, funding may be made requested on an individual patient basis from the Greater Manchester Shared Services IFR Team. Greater Manchester Chief Finance Officers/Greater Manchester Heads of Commissioning Greater Manchester Association Governing Group 28/04/2016 N/A 03/05/2016 N/A Bolton Clinical Commissioning Group 27/05/2016 Recommended funding mechanism above Bury Clinical Commissioning Group 01/06/2016 Recommended funding mechanism above Heywood, Middleton & Rochdale Clinical Commissioning Group Central Manchester Clinical Commissioning Group North Manchester Clinical Commissioning Group 15/07/2016 Recommended funding mechanism above 02/07/2016 Recommended funding mechanism above 07/07/2016 Recommended funding mechanism above Oldham Clinical Commissioning Group 03/05/2016 Recommended funding mechanism above Salford Clinical Commissioning Group 03/05/2016 Recommended funding mechanism above South Manchester Clinical Commissioning Group 03/07/2016 Recommended funding mechanism above Stockport Clinical Commissioning Group 03/05/2016 Recommended funding mechanism above Tameside & Glossop Clinical Commissioning Group 22/06/2016 Recommended funding mechanism above Trafford Clinical Commissioning Group 17/05/2016 Recommended funding mechanism above Wigan Borough Clinical Commissioning Group 01/06/2016 Recommended funding mechanism above GM TES for Facial Palsy Policy v1.2 FINAL Page 5 of 17

6 CONTENTS Policy Statement... 7 Equality & Equity Statement... 7 Governance Arrangements Introduction Definition Aims and Objectives Criteria for Commissioning Description of Epidemiology and Need Evidence Summary Rationale behind the Policy Statement Adherence to NICE Guidance Mechanism for Funding Audit Requirements Documents which have informed this Policy Links to other Policies Date of Review Glossary References Appendix 1 Evidence Review GM TES for Facial Palsy Policy v1.2 FINAL Page 6 of 17

7 Policy Statement Greater Manchester Shared Services (GMSS) has developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission trophic electrical stimulation for facial palsy in accordance with the criteria outlined in this document. In creating this policy GMSS has reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester. Equality & Equity Statement GMSS/CCG has a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act GMSS/CCG is committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, GMSS/CCG will have due regard to the different needs of protected characteristic groups, in line with the Equality Act This document is compliant with the NHS Constitution and the Human Rights Act This applies to all activities for which they are responsible, including policy development, review and implementation. In developing policy the GMSS Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group. The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their starting point is considered to be further back than any other group. This will be reflected in GMSS evidencing taking due regard for fair access to healthcare information, services and premises. An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact policyfeedback.gmscu@nhs.net. Governance Arrangements Greater Manchester EUR policy statements will be ratified by the Greater Manchester Association Governing Group (AGG) prior to formal ratification through CCG Governing Bodies. Further details of the governance arrangements can be found in the Greater Manchester EUR Operational Policy. 1. Introduction This commissioning policy has been produced in order to provide and ensure equity, consistency and clarity in the commissioning of trophic electrical stimulation for facial palsy by Clinical Commissioning Groups in Greater Manchester. When this policy is reviewed all available additional data on outcomes will be included in the review and the policy updated accordingly. Trophic electrical stimulation is a treatment aimed at restoring the function of the muscles of the face through mimicking the stimulation provided from the normal nerve functioning. The majority of facial palsies that are idiopathic or infective will resolve spontaneously usually within 3 months. GM TES for Facial Palsy Policy v1.2 FINAL Page 7 of 17

8 This policy has been developed to target this resource at those cases where there is residual weakness after the normal period when resolution would be expected or where there is traumatic damage to the nerve e.g. from surgery to remove a tumour of the face. It is targeted at those patients where there are functional issues including inability to effectively close their eyes, difficulty speaking and difficulty eating. 2. Definition Facial Palsy / Paralysis Facial palsy refers to weakness of the facial muscles, resulting from temporary or permanent damage to the facial nerve. When a facial nerve is either non-functioning or missing, the muscles in the face do not receive the necessary signals in order to function properly. This results in paralysis of the affected part of the face, which can affect movement of the eye(s) and/or the mouth, as well as other areas. There are different degrees of facial paralysis: sometimes only the lower half of the face is affected, sometimes one whole side of the face is affected and in some cases both sides of the face are affected. The face sags and is drawn across to the opposite side on smiling. Voluntary eye closure may not be possible and can produce damage to the conjunctiva and cornea. In partial paralysis, the lower face is generally more affected. In severe cases, there is often demonstrable loss of taste over the front of the tongue and intolerance to high-pitched or loud noises. It may cause mild dysarthria and difficulty with eating. The most common system used for describing the degree of paralysis is the House-Brackmann scale, where 1 is normal power and 6 is total paralysis. It is important to identify whether the patient has an upper motor neurone (UMN) or lower motor neurone (LMN) lesion, to assist in identifying the cause. Trophic Electrical Stimulation Electrical stimulation has been widely used over the years and is known to help certain nerve muscle problems. Initial stimulation techniques focused on making the muscle move with the electrical impulses hoping that this would promote recovery (Faradism), with new advances in technology it is now possible to embark on a more specific conditioning of the system involved. Electrical stimulation is a treatment offered for a number of nerve muscle related problems such as Bell's Palsy and other forms of facial paralysis. Trophic Electrical Stimulation (TES) can be applied to muscles to promote the uptake of fresh blood supply. By providing the right nutrition, growth occurs. The treatment provides a way of warming up the muscle, targeting the deep red base layers, the first to deteriorate where a nerve supply has been disrupted. Unlike beauty machines TES rebuilds the deeper muscle fibres promoting long lasting results. 3. Aims and Objectives Aim This policy document aims to specify the conditions under which trophic electrical stimulation for facial palsy be routinely commissioned by Clinical Commissioning Groups in Greater Manchester. Objectives To reduce the variation in access to trophic electrical stimulation for facial palsy. To ensure that trophic electrical stimulation for facial palsy is commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness. GM TES for Facial Palsy Policy v1.2 FINAL Page 8 of 17

9 To reduce unacceptable variation in the commissioning of trophic electrical stimulation for facial palsy across Greater Manchester. To promote the cost-effective use of healthcare resources. 4. Criteria for Commissioning Mandatory Criteria OR Chronic idiopathic facial palsy (Bell s palsy) which has not responded to treatment in 6 months with steroids (usually prednisolone); eye care measures and possible referral to physiotherapy (this would be optional rather than mandatory) or for cases of recurrent idiopathic facial palsy (Bell s palsy). Cases of nerve damage where the specialist managing the case has provided evidence in support of referral for trophic electrical stimulation (evidence should include the cause of the nerve damage; treatment tried to date and outcomes for each one tried; functional issues associated with the damage; expected outcomes from TES) AND in all cases there must be demonstrable functional problems associated with the palsy, including but not restricted to: o difficulty closing the eye o difficulty articulating speech o difficulty in eating and drinking o difficulty with facial expressions sufficient to interfere with non-verbal communication Policy Exclusions Clinicians can submit an Individual Funding Request (IFR) if they feel there is a good case for exceptionality. Exceptionality means a person to which the general rule is not applicable. Greater Manchester sets out the following guidance in terms of determining exceptionality; however the over-riding question which the IFR process must answer is whether each patient applying for exceptional funding has demonstrated that his/her circumstances are exceptional. A patient may be able to demonstrate exceptionality by showing that s/he is: Significantly different to the general population of patients with the condition in question. and as a result of that difference They are likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition. 5. Description of Epidemiology and Need Full recovery occurs in about 80% of the cases, 15% experience some kind of permanent nerve damage and 5% remain with severe sequelae. The incidence of Facial Palsy is around 30 per 100,000 1 the commonest condition being Bell s palsy. Bell's Palsy 1 Source = Patient.co.uk GM TES for Facial Palsy Policy v1.2 FINAL Page 9 of 17

10 The lifetime prevalence of Bell s palsy is between 6.4 to 20 per 1,000. The incidence increases with age, the overall annual incidence of Bell s palsy is: 0.2 to 0.5 per 1,000 population. The annual incidence increases over time from 0.1 per 1,000 at age 20 to 0.6 per 1,000 at age 80. It is equally common in men and women but may have a slight female predominance. It commonly affects the right side (63%) and has a recurrence rate of 7%. Its incidence increases in patients with diabetes and in pregnancy, especially in the 3rd trimester. The overall prognosis is better in younger patients with no previous history of Bell s palsy where treatment is commenced in the first 3 days and when the following disease features are present: Incomplete paralysis Early improvement Slow progression Normal: o Salivary flow o Taste o Hearing Electrodiagnostic tests normal (Nerve excitability ; Electrogustometry) Improvement begins between 10 days and 2 months. The following residual signs may be present to a varying degree: Synkinesis in approximately 50% of cases this may be reduced by corticosteroid treatment Residual facial weakness: 30% Contracture: 20% Crocodile tears: 6% Blepharospasm: May occur years after paralysis 6. Evidence Summary There is limited evidence available for this intervention. This is not unusual as it is a form of physical therapy and as such evidence to level expected of medical or surgical interventions is not always available. There is some low level evidence of the effectiveness of physiotherapy with or without electrical stimulation in the form of case series and individual case studies this is not cited here as local experience of using this type of service provides a number of individual case studies of this intervention and there for additional case studies add little if any additional information. The limited evidence available suggests that this intervention may have a place in chronic or recurrent idiopathic facial palsy (Bell s Palsy) and in traumatic injury to the nerves of the face (usually as a side effect of facial surgery). Full details of the Evidence Review are contained with Appendix Rationale behind the Policy Statement Whilst there is evidence, the evidence available is low grade (case studies and case series) but is supportive of the treatment this is not unusual in the physical therapies. Local experience of the use of the service suggests that in selected patients this is an effective intervention. To ensure the best use of resources the mandatory criteria have been set to identify individuals likely to gain the most benefit from GM TES for Facial Palsy Policy v1.2 FINAL Page 10 of 17

11 this intervention. All individuals meeting the criteria will be referred for an assessment of the potential outcome and that assessment will be reviewed by the relevant IFR panel for individual potential benefit. 8. Adherence to NICE Guidance NICE have not currently issued guidance on this treatment. 9. Mechanism for Funding Clinical Commissioning Group Bolton Bury Heywood, Middleton & Rochdale Manchester Central Manchester North Manchester South Oldham Salford Stockport Tameside & Glossop Trafford Wigan Funding Mechanism Funding for the initial assessment will be via prior approval from the Greater Manchester Shared Services IFR Team. Requests for an assessment will be approved or declined at screening in line with the mandatory criteria by the EUR team. On receipt of the assessment report from the provider (or if the initial application includes an assessment report) cases can be approved or declined by clinical triage in line with the mandatory criteria. Any requests requiring further discussion will be sent onto CCG Panels for consideration. Any requests for an extension of funding will be reviewed by triage but must be accompanied by a detailed progress report that includes the expected outcome from the extended treatment. Any requests requiring further discussion will be sent onto CCG Panels for consideration. For all other cases if they are felt to be exceptional, funding may be made requested on an individual patient basis from the Greater Manchester Shared Services IFR Team. 10. Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request. 11. Documents which have informed this Policy Greater Manchester EUR Operational Policy 12. Links to other Policies This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR). 13. Date of Review One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group (unless stated this will be every 2 years). 14. Glossary GM TES for Facial Palsy Policy v1.2 FINAL Page 11 of 17

12 Term Blepharospasm Contracture Corticosteroid Crocodile tears Electrodiagnostic tests Electrogustometry Faradism Idiopathic Infective Lower motor neurone (LMN) lesion Nerve excitability Residual facial weakness Sequelae Synkinesis Upper motor neurone (UMN) Meaning Involuntary tight closure of the eyelids. A condition of shortening and hardening of muscles, tendons, or other tissue, often leading to deformity. Any of a group of steroid hormones produced in the adrenal cortex or made synthetically. There are two kinds: glucocorticoids and mineralocorticoids. They have various metabolic functions and some are used to treat inflammation. Production of tears not related to emotional triggers. Involving or obtained by the recording of responses to electrical stimulation for purposes of diagnosing a pathological condition. The testing of the sense of taste by application of mild electrical stimuli to the tongue. A method of passive exercise which can be applied locally to stimulate nerves and muscles. Relating to or denoting any disease or condition which arises spontaneously or for which the cause is unknown. Pertaining to or characterized by the presence of pathogens. Neurons located in either the anterior grey column, anterior nerve roots (spinal lower motor neurons) or the cranial nerve nuclei of the brainstem and cranial nerves with motor function. The readiness of a nerve cell to respond to a stimulus. The remaining weakness of movement of the face following treatment. A condition which is the consequence of a previous disease or injury. Involuntary muscular movements accompanying voluntary movements. For example, voluntary smiling will induce an involuntary contraction of the eye muscles causing the eye to squint when the subject smiles. Neurons that originate either in the motor region of the cerebral cortex or in the brain stem and carry motor information down to the lower motor neurons (motor stimuli are those that result in movement). References N/A GM TES for Facial Palsy Policy v1.2 FINAL Page 12 of 17

13 Appendix 1 Evidence Review Trophic Electrical Stimulation (TES) for Facial Palsy GM005 Search Strategy Database NICE Result Nil found NHS Evidence and NICE CKS Cochrane review (see citation below) NICE CKS guidance on treating Bell s palsy with corticosteroid (not cited here) Best Bets webpage: Electrical stimulation and Bells' Palsy SIGN Cochrane York BMJ Clinical Evidence BMJ Best Practice General Search (Google) Nil found Physical therapy for Bell s palsy (idiopathic facial paralysis) Teixeira LJ, Valbuza JS, PradoGF. Cochrane Database of Systematic Reviews 2011, Issue 12. Art. No.: CD Nil found Nil found Care pathway for Bell s palsy (not cited here) Websites offering specific services and general information on trophic stimulation (not cited here) Medline / Open Athens Comprehensive facial rehabilitation improves function in people with facial paralysis: a 5-year experience at the Massachusetts Eye and Ear Infirmary Lindsay, Robin W. Robinson, Mara. Hadlock, Tessa A. Physical Therapy. 90(3):391-7, 2010 Mar. Some case studies citing use of electrical stimulation (not cited here) Most papers related to Bell s palsy and acupuncture plus/minus corticosteroid therapy (none cited here) Other Royal College websites Nil found Summary of the evidence There is limited evidence available for this intervention. This is not unusual as it is a form of physical therapy and as such evidence to level expected of medical or surgical interventions is not always available. There is some low level evidence of the effectiveness of physiotherapy with or without electrical stimulation in the form of case series and individual case studies this is not cited here as local experience of using this type of service provides a number of individual case studies of this intervention and there for additional case studies add little if any additional information GM TES for Facial Palsy Policy v1.2 FINAL Page 13 of 17

14 The limited evidence available suggest that this intervention may have a place in chronic or recurrent idiopathic facial palsy (Bell s Palsy) and in traumatic injury to the nerves of the face (usually as a side effect of facial surgery). The evidence Levels of evidence Level 1 Level 2 Level 3 Level 4 Level 5 Meta-analyses, systematic reviews of randomised controlled trials Randomised controlled trials Case-control or cohort studies Non-analytic studies e.g. case reports, case series Expert opinion 1. LEVEL 1: SYSTEMATIC REVIEW Physical therapy for Bell s palsy (idiopathic facial paralysis) Teixeira LJ, Valbuza JS, PradoGF. Cochrane Database of Systematic Reviews 2011, Issue 12. Art. No.: CD Background: Bell s palsy (idiopathic facial paralysis) is commonly treated by various physical therapy strategies and devices, but there are many questions about their efficacy. Objectives: To evaluate physical therapies for Bell s palsy (idiopathic facial palsy). Search methods: We searched the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2011), MEDLINE (January 1966 to February 2011), EMBASE (January 1946 to February 2011), LILACS (January1982 to February 2011), PEDro (from 1929 to February 2011), and CINAHL (January 1982 to February 2011).We included searches in clinical trials register databases until February Selection criteria: We selected randomised or quasi-randomised controlled trials involving any physical therapy. We included participants of any age with a diagnosis of Bell s palsy and all degrees of severity. The outcome measures were: incomplete recovery six months after randomisation, motor synkinesis, crocodile tears or facial spasm six months after onset, incomplete recovery after one year and adverse effects attributable to the intervention. Data collection and analysis: Two authors independently scrutinised titles and abstracts identified from the search results. Two authors independently carried out risk of bias assessments, which took into account secure methods of randomisation, allocation concealment, observer blinding, patient blinding, incomplete outcome data, selective outcome reporting and other bias. Two authors independently extracted data using a specially constructed data extraction form. We undertook separate subgroup analyses of participants with more and less severe disability Main results: For this update to the original review, the search identified 65 potentially relevant articles. Twelve studies met the inclusion criteria (872participants). Four trials studied the efficacy of electrical stimulation (313 participants), three trials studied exercises (199 participants), and five studies compared or combined some form of physical therapy with acupuncture (360 participants). For most outcomes we were unable to perform meta-analysis because the interventions and outcomes were not comparable. For the primary outcome of incomplete recovery after six months, electrostimulation produced no benefit over placebo (moderate quality evidence from one study with 86 participants). Low quality comparisons of electrostimulation with prednisolone (an active treatment) (149 participants), or the addition of electrostimulation to hot packs, massage and facial exercises (22 participants), reported no significant GM TES for Facial Palsy Policy v1.2 FINAL Page 14 of 17

15 differences. Similarly a meta-analysis from two studies, one of three months and the other of six months duration (142participants) found no statistically significant difference in synkinesis, a complication of Bell s palsy, between participants receiving electrostimulation and controls. A single low quality study (56 participants), which reported at three months, found worse functional recovery with electrostimulation (mean difference (MD) points (scale of 0 to 100) 95% confidence interval (CI) 1.26 to 22.74). Two trials of facial exercises, both at high risk of bias, found no difference in incomplete recovery at six months when exercises were compared to waiting list controls or conventional therapy. There is evidence from a single small study (34 participants) of moderate quality that exercises are beneficial on measures of facial disability to people with chronic facial palsy when compared with controls (MD points (scale of 0 to 100), 95% CI 8.76 to 32.04) and from another single low quality study with 145 people with acute cases treated for three months, in which significantly fewer participants developed facial motor synkinesis after exercise (risk ratio % CI 0.08 to 0.69). The same study showed statistically significant reduction in time for complete recovery, mainly in more severe cases (47 participants, MD weeks, 95% CI to -1.05) but this was not a prespecified outcome in this meta analysis. Acupuncture studies did not provide useful data as all were short and at high risk of bias. None of the studies included adverse events as an outcome. Authors conclusions: There is no high quality evidence to support significant benefit or harm from any physical therapy for idiopathic facial paralysis. There is low quality evidence that tailored facial exercises can help to improve facial function, mainly for people with moderate paralysis and chronic cases. There is low quality evidence that facial exercise reduces sequelae in acute cases. The suggested effects of tailored facial exercises need to be confirmed with good quality randomised controlled trials. 2. LEVEL 3: RETROSPECTIVE REVIEW Comprehensive facial rehabilitation improves function in people with facial paralysis: a 5- year experience at the Massachusetts Eye and Ear Infirmary Lindsay, Robin W. Robinson, Mara. Hadlock, Tessa A. Physical Therapy. 90(3):391-7, 2010 Mar. Background: The Facial Grading Scale (FGS) is a quantitative instrument used to evaluate facial function after facial nerve injury. However, quantitative improvements in function after facial rehabilitation in people with chronic facial paralysis have not been shown. Objective: The objectives of this study were to use the FGS in a large series of consecutive subjects with facial paralysis to quantitatively evaluate improvements in facial function after facial nerve rehabilitation and to describe the management of chronic facial paralysis Design: The study was a retrospective review Methods: A total of 303 individuals with facial paralysis were evaluated by 1 physical therapist at a tertiary care facial nerve center during a 5-year period. Facial rehabilitation included education, neuromuscular training, massage, meditation-relaxation, and an individualized home program. After 2 months of home exercises, the participants were re-evaluated, and the home program was tailored as necessary. All participants were evaluated with the FGS before the initiation of facial rehabilitation, and 160 participants were re-evaluated after receiving treatment. All participants underwent the initial evaluation at least 4 months after the onset of facial paralysis; for 49 participants, the evaluation took place more than 3 years after onset. Results: Statistically significant increases in FGS scores were seen after treatment (P<.001, t test). The average initial score was 56 (SD=21, range=13-98), and the average score after treatment was 70 (SD=18, range=25-100) GM TES for Facial Palsy Policy v1.2 FINAL Page 15 of 17

16 Limitations: A limitation of this study was that evaluations were performed by only 1 therapist. Conclusions: For 160 patients with facial paralysis, statistically significant improvements after facial rehabilitation were shown; the improvements appeared to be long lasting with continued treatment. The improvements in the FGS scores indicated that patients can successfully manage symptoms with rehabilitation and underscored the importance of specialized therapy in the management of facial paralysis. 3. LEVEL 4: INITIALLY CITED AS A SYSTEMATIC REVIEW BUT IN ACTUALITY WAS A CRITIC OF A SINGLE PAPER Best Bets webpage: Electrical stimulation and Bells' Palsy Report By: Susan J Buttress - Research Physiotherapist, Search checked by Katrina Herren - Research Fellow, Institution: Manchester Royal Infirmary, Last Modified: 16th September 2002 Three Part Question: In [facial nerve palsy] are [facial exercises better than electrical stimulation] at improving [time to function/facial symmetry]? Clinical Scenario: A 50-year-old presents with Bells' Palsy. You have heard that physiotherapy is an effective treatment but wonder whether facial exercises produce a better outcome than treatment with electrical stimulation. Search Strategy: Medline and CINAHL /02, AMED /02 using the OVID interface. Medline and CINAHL: [{facial nerve palsy.mp OR exp facial paralysis OR exp bells palsy}] AND ["trophic stimulation".mp OR exp physical therapy techniques OR "physiotherapy".mp OR exp electric stimulation OR exp electric stimulation therapy OR "electrical stimulation".mp OR electrotherapy.mp}] LIMIT to human AND English. AMED: {exp peripheral nerve disease} AND {exp electrotherapy}. Search Outcome: Medline and CINAHL: 253 papers were identified, AMED: 17 papers found 11 of which were relevant, but 10 papers were excluded since these described electromyographic feedback (EMG feedback training) which is not a form of electrical stimulation. The remaining paper is shown in the table. Relevant Paper(s) Author, date and country Patient group Study type (level of evidence) Outcomes Key results Study Weaknesses Farragher D et al, patients with a 74 months mean interval between onset and starting treatment. Stimulation v no stimulation Clinical Trial FPRP (Facial Paralysis Recovery Profile) FPRI (Facial Paralysis Recovery Index) FPRI (Facial Paralysis Recovery Index) p< p< p< Not randomised FPRP (Facial Paralysis Recovery Profile) p< Comment(s): No papers were found which involved physiotherapy treatment of Bells' Palsy in the acute setting. The above paper describes significant differences in the outcomes used for patients with longterm facial nerve palsy using electrical stimulation, however this was not a rigorous study. GM TES for Facial Palsy Policy v1.2 FINAL Page 16 of 17

17 Clinical Bottom Line: There is no evidence to suggest that either exercises or electrical stimulation is beneficial to patients with acute Bells' Palsy. Evidence does exist to justify the use of electrical stimulation in patients with long-term Bells' Palsy, although the study could have been more rigorous. References 1. Farragher D, Kidd GL, Tallis R. Eutrophic stimulation for Bells' Palsy. Clinical Rehabilitation 1987:1(4): GM TES for Facial Palsy Policy v1.2 FINAL Page 17 of 17