Greater Manchester EUR Policy Statement on: Functional Electrical Stimulation (FES) for Foot Drop GM Ref: GM036 Version: 2.

Transcription

1 Greater Manchester EUR Policy Statement on: Functional Electrical Stimulation (FES) for Foot Drop GM Ref: GM036 Version: 2.1 (6 June 2018)

2 Commissioning Statement Functional Electrical Stimulation (FES) for Foot Drop Policy Exclusions Other forms of electrical stimulation e.g. PENS and TENS for conditions other than foot drop are not covered by this policy. Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect). Policy Inclusion Criteria The patient must be being treated for foot drop which must be of central neurological origin, due to an upper motor neurone lesion i.e. one that occurs in the brain or spinal cord at or above the level of T12. This is normally but not exclusively associated with spasticity. Upper motor neurone lesions resulting in dropped foot occur in conditions such as stroke, multiple sclerosis, incomplete spinal cord injury at T12 or above, cerebral palsy, familial /hereditary spastic paraparisis and Parkinson's disease. In some cases wireless FES devices may be required, if this is the case then the application form should contain all relevant information for checking against the criteria in Appendix 2. Funding Mechanism Wired: Individual prior approval provided the patient meets the above criteria. Requests should be submitted with all relevant supporting evidence, which must be provided with the request. Wireless: Individual prior approval via Clinical Triage provided the patient meets the above criteria. Requests should be submitted with all relevant supporting evidence and information listed from the criteria in Appendix 2, which must be provided with the request. Clinical Exceptionality Clinicians can submit an Individual Funding Request (IFR) outside of this guidance 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. GM FES for Foot Drop Policy v2.1 FINAL Page 2 of 23

3 Contents Commissioning Statement... 2 Policy Statement... 4 Equality & Equity Statement... 4 Governance Arrangements... 4 Aims and Objectives... 4 Rationale behind the policy statement... 5 Treatment / Procedure... 5 Epidemiology and Need... 5 Adherence to NICE Guidance... 6 Audit Requirements... 6 Date of Review... 6 Glossary... 6 References... 7 Governance Approvals... 7 Appendix 1 Evidence Review... 8 Appendix 2 Consideration of applications for wireless devices Appendix 3 Diagnostic and Procedure Codes Appendix 4 Version History GM FES for Foot Drop Policy v2.1 FINAL Page 3 of 23

4 Policy Statement Greater Manchester Shared Services (GMSS) Effective Use of Resources (EUR) Policy Team in conjunction with GM EUR Steering Group have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures 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. 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). Equality & Equity Statement GMSS/CCGs have 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. Aims and Objectives This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by: reducing the variation in access to treatments/procedures. GM FES for Foot Drop Policy v2.1 FINAL Page 4 of 23

5 ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness. reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester. promoting the cost-effective use of healthcare resources. Rationale behind the policy statement Although the evidence base is relatively weak there is evidence to suggest that FES is a cost effective intervention for foot drop of central neurological origin. To ensure that the resource available to fund this intervention is targeted to the group that will gain the most benefit FES is routinely commissioned for this group only. All other uses of FES will be commissioned as part of a local pathway of care where appropriate or as part of a trial as appropriate and subject to local arrangements for trials and studies. Treatment / Procedure FES has a number of applications, not all of which have a sound body of evidence to support their routine use. This policy aims to target the resource available for this intervention to those patients where there is evidence that they will benefit the most from the intervention. Functional Electrical Stimulation (FES) is a treatment using small electrical charges to improve mobility in a number of conditions. There is a reasonable body of evidence and it is recognised as cost effective for foot drop of central neurological and of upper motor neurone origin it is used mostly for foot drop following stroke or in Multiple Sclerosis. Dropped foot Dropped foot occurs when damage to nerve pathways means someone experiences weakness or poor coordination in their leg or ankle which affects the way that they walk. Dropped foot leads to a way of walking that requires more effort and uses more energy. The foot may drag along the ground or the toes hang down when walking, which makes the individual more vulnerable to tripping and falling. People may alter the way that they walk to compensate, commonly lifting their leg higher. In time, this can lead to further problems such as pain in the hips or lower back, a tightening of muscles and poor balance. Devices Several different FES devices are available. Each has a control box, about the size of a pack of cards, which is either worn on the leg or at the waist. The devices apply impulses through electrodes attached to the skin. A version is also available that uses a surgically implanted nerve stimulator. These work by replacing the stimulation normally received from the brain to the muscles controlling the position of the foot resulting in a basic but useful movement. The device is activated by a pressure sensitive switch in the shoe. When the foot is lifted, an impulse is applied causing the foot to tilt to the correct angle. When the foot is placed on the ground again, pressure is reapplied to the switch and the impulse ceases. Epidemiology and Need Foot drop of central neurological origin is most commonly due to Stroke or Multiple Sclerosis (MS). There are approximately 152,000 strokes in the UK every year, foot drop is a common sequelae of strokes. GM FES for Foot Drop Policy v2.1 FINAL Page 5 of 23

6 A study of the UKGP database estimated that 126,669 people were living with MS in the UK in 2010 (203.4 per 100,000 population) and that 6,003 new cases were diagnosed that year (9.64 per /year). There is an increasing population living longer with MS, which has important implications for resource allocation for MS in the UK 2. Adherence to NICE Guidance This policy adheres to the guidance in NICE IPG278: Functional electrical stimulation for drop foot of central neurological origin. Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request. Date of Review Five years from the date of the last review, unless new evidence or technology is available sooner. The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review. Glossary Term Central neurological Cerebral Palsy Familial hereditary spastic paraparisis IPG Multiple Sclerosis NICE Parkinson's disease. Sequelae Stroke T12 or above Meaning Pertaining to the part of the nervous system consisting of the brain and spinal cord. A condition marked by impaired muscle coordination (spastic paralysis) and/or other disabilities, typically caused by damage to the brain before or at birth. A group of inherited disorders that cause weakness and stiffness of the leg muscles, which gradually gets worse over time. Interventional Procedure Guidance A progressive disease involving damage to the sheaths of nerve cells in the brain and spinal cord, whose symptoms may include numbness, impairment of speech and of muscular coordination, blurred vision, and severe fatigue. National Institute for Health and Care Excellence A progressive disease of the nervous system marked by tremor, muscular rigidity, and slow, imprecise movement, chiefly affecting middle-aged and elderly people. It is associated with degeneration of the basal ganglia of the brain and a deficiency of the neurotransmitter dopamine. A condition which is the consequence of a previous disease or injury. A stroke is the sudden death of brain cells in a localized area due to inadequate bloodflow. Thoracic vertebrae 12 or above. GM FES for Foot Drop Policy v2.1 FINAL Page 6 of 23

7 Upper motor neurone 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 1. Greater Manchester Effective Use of Resources Operational Policy 2. Incidence and prevalence of multiple sclerosis in the UK : a descriptive study in the General Practice Research Database, I.S. MacKenzie et al, J Neurol Neurosurg Psychiatry doi: /jnnp Governance Approvals Name Date Approved Greater Manchester Effective Use of Resources Steering Group 08/07/2015 Greater Manchester Chief Finance Officers / Greater Manchester Directors of Commissioning 28/04/2016 Greater Manchester Association Governing Group 03/05/2016 Bury Clinical Commissioning Group 27/05/2016 Bolton Clinical Commissioning Group 01/06/2016 Heywood, Middleton & Rochdale Clinical Commissioning Group 15/07/2016 Central Manchester Clinical Commissioning Group 02/07/2016 North Manchester Clinical Commissioning Group 07/07/2016 Oldham Clinical Commissioning Group 03/05/2016 Salford Clinical Commissioning Group 03/05/2016 South Manchester Clinical Commissioning Group 03/07/2016 Stockport Clinical Commissioning Group 03/05/2016 Tameside & Glossop Clinical Commissioning Group 22/06/2016 Trafford Clinical Commissioning Group 17/05/2016 Wigan Borough Clinical Commissioning Group 01/06/2016 GM FES for Foot Drop Policy v2.1 FINAL Page 7 of 23

8 Appendix 1 Evidence Review Functional Electrical Stimulation (FES) for Foot Drop GM036 Search Strategy The following databases are routinely searched: NICE Clinical Guidance and full website search; NHS Evidence and NICE CKS; SIGN; Cochrane; York; BMJ Clinical Evidence; and the relevant Royal College websites. A Medline / Open Athens search is undertaken where indicated and a general google search for key terms may also be undertaken. The results from these and any other sources are included in the table below. If nothing is found on a particular website it will not appear in the table below: Database NICE NHS Evidence and NICE CKS SIGN Cochrane Result IPG 278: Functional electrical stimulation for drop foot of central neurological origin CRD (York) reviews cited below SIGN 119: Management of patients with stroke: identification and management of dysphagia cited reviews already listed so not cited here Nil additional York (CRD) Surface-applied functional electrical stimulation for orthotic and therapeutic treatment of drop-foot after stroke: a systematic review, Roche A, o Laighin G, Coote S The long-term cost-effectiveness of the use of Functional Electrical Stimulation for the correction of dropped foot due to upper motor neuron lesion, Taylor P, Humphreys L, Swain I Health and fitness benefits of functional electrical stimulation-evoked leg exercise for spinal cord-injured individuals: a position review, Hamzaid NA, Davis GM Functional electrical stimulation in the treatment of patients with chronic heart failure: a meta-analysis of randomized controlled trials, Sbruzzi G, Ribeiro RA, Schaan BD, Signori LU, Silva AM, Irigoyen MC, Plentz RD General Search (Google) Medline / Open Athens Other Multiple self-help and provider websites not cited here Not done as multiple reviews including NICE available NWCSU and Stockport CCG rapid appraisals: NWCSU Evidence Review: Functional electrical stimulation bicycle for patients with spinal cord injury, Date: November 2014 NWCSU Evidence Review: Functional electrical stimulation for the treatment of cauda equine pain, Date: June 2014 NWCSU Evidence Review: Functional electrical stimulation (FES) for the upper limb, Date: 21 October 2014 Stockport CCG Evidence Review: Functional electrical stimulation (FES) for the treatment of arm muscle paralysis, Date: February 2013 GM FES for Foot Drop Policy v2.1 FINAL Page 8 of 23

9 Summary of the evidence There is limited evidence for the cost effectiveness of FES for foot drop of central neurological origin that suggests it is a cost effective way of managing this condition. NICE also recommends further study. 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: NICE IPG NICE IPG 278: Functional electrical stimulation for drop foot of central neurological origin, Issued: January 2009 Guidance a. Current evidence on the safety and efficacy (in terms of improving gait) of functional electrical stimulation (FES) for drop foot of central neurological origin appears adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. b. Patient selection for implantable FES for drop foot of central neurological origin should involve a multidisciplinary team specialising in rehabilitation. 2. LEVEL 1: CRD REVIEW Surface-applied functional electrical stimulation for orthotic and therapeutic treatment of drop-foot after stroke: a systematic review Roche A, o Laighin G, Coote S CRD summary: The review concluded that functional electrical stimulation can have a positive orthotic effect in patients who were in the chronic stage of stroke recovery. In light of the possibility of relevant studies being missed and the moderate or high risk of bias in nearly all included studies, the reliability of the authors' conclusions remains uncertain. Authors' objectives: To evaluate the evidence for orthotic and therapeutic effects of surface functional electrical stimulation for the correction of drop-foot after stroke. Searching: MEDLINE, EMBASE, CINAHL, AMED, Science Direct and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for studies in English published between 1990 and June Search terms were reported. Reference lists of retrieved articles were searched. Study selection: Studies of functional electrical stimulation for correction of drop-foot after adult stroke were eligible for inclusion. Studies that solely used implantable electrodes were excluded, as were studies that did not stimulate the lower limb/common peroneal nerve or tibialis anterior muscle. Most populations were (at least partly) chronic cerebrovascular accident patients. Modes and durations of treatment varied. Comparator group treatments, where they existed, varied and included physiotherapy, botulinum toxin injections, electromechanical gait trainer and different applications of functional electrical stimulation. Several studies used functional electrical stimulation with a cointervention. Studies assessed more than 30 different outcomes; the most common was a measure of walking. GM FES for Foot Drop Policy v2.1 FINAL Page 9 of 23

10 Two reviewers independently selected studies for inclusion. Disagreements were resolved by consensus. Assessment of study quality: Studies were quality assessed according to the presence of bias in relation to the following criteria (from Guidelines for Cochrane Reviewers): selection of participants; performance of care providers; detection of outcomes; and participant attrition. Studies were given an overall risk of bias (low risk when all criteria were met, moderate risk when one or more criteria were partly met or high risk when one or more criteria were not met). The authors did not state how many reviewers performed the quality assessment. Data extraction: The authors did not state how many reviewers performed the data extraction. Methods of synthesis: A narrative synthesis was performed, grouped by study design or type of intervention. Results of the review: Thirty studies were included in the review (n=1,159). Studies incorporated a range of study designs. Sample sizes ranged from one to 291 patients (25 studies had a sample size of fewer than 50 patients). Eleven studies had a high risk of bias, five were moderate-high, 12 were moderate and one was low. Four before-and-after studies reported some orthotic effect using differing stimulators and two studies reported a therapeutic effect. Three studies (two of which had control groups) suggested that functional electrical stimulation may have been better than conventional therapy alone and that a combination of both interventions was more effective than either. No definitive conclusions could be drawn regarding the four studies of functional electrical stimulation with physiotherapy versus physiotherapy alone. Two small studies suggested that botulinum toxin injections followed by three days of functional electrical stimulation may have been more effective than botulinum toxin injections alone. Four studies of functional electrical stimulation and an electromechanical gait trainer with partial body weight support suggested combined therapy may be more effective than over-ground training in both the early and chronic stages of rehabilitation. Authors' conclusions: Functional electrical stimulation can have a positive orthotic effect, particularly for gait speed and physiological cost index, in patients who were in the chronic stage of stroke recovery (although evidence for a therapeutic effect was less conclusive). CRD commentary: The review addressed a clear question and was supported by broad inclusion criteria. Although several electronic databases were searched, the restriction to searching only for published studies in English from 1990 onwards (for purposes of practicality) meant that some relevant studies may have been missed. Suitable methods were employed to reduce risks of reviewer error and bias when selecting studies for inclusion; the authors did not report on whether such methods were used for the processes of data extraction and study quality assessment. Sufficient study details were provided, although the presence of statistical significance was inconsistently reported between studies. The narrative synthesis was somewhat difficult to follow and interpret as a very broad range of study designs and outcomes were reported. Study quality was assessed and used in interpreting the results of the review. Considering that most studies were small, that all studies except one had a moderate or high risk of bias and that some relevant studies may have been missed during the searches, the reliability of the authors' conclusions remains uncertain. 3. LEVEL N/A: COST EFFECTIVENESS REVIEW The long-term cost-effectiveness of the use of Functional Electrical Stimulation for the correction of dropped foot due to upper motor neuron lesion Taylor P, Humphreys L, Swain I CRD Summary: The objective was to assess the long-term cost-effectiveness of functional electrical stimulation (FES) for the correction of dropped foot due to damage to the upper motor neurone. The authors concluded that FES was cost effective. The validity of the data was unclear, due to limitations in the study methods and a lack of detail in the reporting. The results are uncertain and should be considered with these limitations in mind. GM FES for Foot Drop Policy v2.1 FINAL Page 10 of 23

11 Type of economic evaluation: Cost-effectiveness analysis, cost-utility analysis Study objective: The objective was to assess the long-term cost-effectiveness of functional electrical stimulation (FES) for the correction of dropped foot due to damage to the upper motor neurone. Interventions: FES was applied to the common peroneal nerve, producing dorsiflexion and eversion, timed to the swing phase of gait, using a heal switch. The comparator was no such stimulation. Location/setting: UK/secondary care. METHODS Analytical approach: A retrospective review of medical records was conducted to assess the long-term costs and benefits of FES. Follow-up assessments were conducted for as long as the device was used (mean 4.9 years). The perspective was not stated. Effectiveness data: The key effectiveness outcome was the change in 10 metre walking speed. This was from the retrospective review of the records of 126 patients who were referred for treatment by a general practitioner or medical consultant. Patients began treatment in 1999 and were suffering from stroke, multiple sclerosis, spinal cord injury, cerebral palsy, or unspecified conditions. Four comparisons were used: the initial orthotic effect (with FES, end versus start of first day); the total orthotic effect (with FES, follow-up versus start); the training effect (without FES, follow-up versus start); and continuing orthotic effect (with versus without FES, at follow-up). Walking speed was measured at six, 18 and 42 weeks, and then every six or 12 months for as long as the device was used. The clinical utility of the change in walking speed was measured as the number of patients who changed functional walking category in the first 16.5 months of treatment (last point at which data were available for all patients). Monetary benefit and utility valuations: An estimate of the utility gain associated with FES per year was derived from an economic report produced by the UK's Purchasing and Supply Agency, in The gain was calculated by translating the proportion of FES users crossing key walking speed thresholds to changes in the Health Utilities Index (HUI3). This calculation took account of the number of FES users with reduced utility due to skin reaction to the electrodes. Measure of benefit: The health benefit was measured by increased walking speed and quality-adjusted life-years (QALYs). Cost data: The costs were calculated using hospital tariffs, for each clinic assessment. These included all device, consumables and clinical costs. They were reported in 2012 UK. Analysis of uncertainty: The variation in estimates was presented as standard deviations and 95% confidence intervals. Results: The effects were only reported for stroke and multiple sclerosis patients, as there were insufficient data for the other patients. Continuing orthotic effect: at the end of the observation period, stroke patients walked 0.08 metres per second (m/s) faster with FES than without it (p<0.001); multiple sclerosis patients walked 0.06m/s faster (p=0.001). Training effect: without FES, stroke patients walked 0.11m/s faster than at the start (p<0.001); multiple sclerosis patients walked 0.05m/s slower. Total orthotic effect: with FES at any time point compared with no FES at the start, stroke patients increased their walking speed by 0.18m/s (p<0.001), and multiple sclerosis patients increased speed by 0.02m/s (p<0.001). Over 16.5 months, 42 patients (38%) improved their functional walking category using FES. The total mean cost per patient was 3,130 (SD 1,830) for stroke patients, and 3,095 (SD 1,490) for all patients. The mean QALY gain was 0.041, which was assumed to be the same for all patients. The mean cost per QALY was 15,268 for stroke patients, and 15,406 for all patients. Authors' conclusions: The authors concluded that FES was cost-effective. CRD COMMENTARY Interventions: The intervention was clearly stated. A limited description was given, with details reported in another publication. It was unclear if no stimulation was the standard practice; and if other treatments should have been considered. Appropriate comparators are crucial in determining cost-effectiveness. GM FES for Foot Drop Policy v2.1 FINAL Page 11 of 23

12 Effectiveness/benefits: The effectiveness measures were from a before-and-after study; an observational design with known risks of bias. No attempts to deal with any bias were reported. The authors considered improvements over time without FES (the training effect), but they suggested that the outcomes without FES were expected to improve as a result of using FES in general (a spill lover effect). So this result would not reflect the change in outcomes for a patient who never received the intervention. The effectiveness outcomes are uncertain. Limited details of the methods used to derive the utility were reported; the validity of the values used is unclear. The same utility gain was used for all patients, regardless of the cause of dropped foot. Costs: The cost estimates were clearly reported and appear to have been appropriate. The costs seem to represent a health service provider (UK NHS) perspective, but this was not explicitly reported. No discounting was applied to the cost or benefit outcomes. Assuming that the costs and benefits were only accrued whilst using the device, and it was used for less than two years, discounting was not necessary. For long-term use, discounting would be relevant. Analysis and results: The results of the analysis were clearly reported. Interpreting the cost per QALY results as cost-effectiveness ratios assumes that there was no cost and no benefit associated with the comparator. This is unlikely to reflect standard practice, where alternative interventions accrue costs and benefits, which would alter the cost-effectiveness results. No analysis of parameter uncertainty was conducted, so it was unclear how sensitive the results were to uncertainties in the cost and benefit estimates. Concluding remarks: The validity of the data was unclear, due to limitations in the study methods and a lack of detail in the reporting. The results are uncertain and should be considered with these imitations in mind. 4. LEVEL 1: CRD REVIEW Health and fitness benefits of functional electrical stimulation-evoked leg exercise for spinal cord-injured individuals: a position review Hamzaid NA, Davis GM CRD summary: This review concluded that across a variety of outcome domains functional electrical stimulation-evoked leg exercise promoted certain health and fitness benefits for people with spinal cord injury. Poor reporting of the review process, inclusion of small studies of unknown quality and the possibility of language and publication biases suggests that these conclusions should be treated with caution. Authors' objectives: To investigate whether functional electrical stimulation (FES)-evoked leg exercise promoted health and fitness benefits in people with spinal cord injury. Searching: MEDLINE, MEDLINE Daily Update, PREMEDLINE, OLDMEDLINE, SPORTDiscus, Web of Science (dates spanned 1830 to 31st July 2008) and The Cochrane Library and Cochrane Database of Systematic Reviews were searched. Search terms were reported. FES-specific annual international conference archives with known peer-review criteria were searched for published studies. Any language was included, provided an English abstract that described clear categorical outcomes was available. Study selection: Studies of FES or functional neuromuscular stimulation (FNS) exercise of lower limbs of neurologically disabled people that evaluated health and fitness outcomes were eligible for inclusion. The term exercise referred mainly to predominantly lower limb physical training activities. Movements that may have involved concurrent upper extremity exercise were not excluded. Studies conducted on functional applications of FES (use of FES for daily activities without exercise training for health and fitness only) or technological developments (control approaches, analyses of FES stimulation parameters and controller performance, simulation and modelling studies or research into the technological domain without intention of describing possible physiological benefits) were included if secondary health and fitness were described. Randomised and non-randomised trials and other controlled studies were eligible for inclusion. Included studies were of a variety of FES interventions. The most common involved FES cycling and some included arm cranking. Duration of included studies appeared to vary from one day to 11 months. Lesion level of patients varied between studies. GM FES for Foot Drop Policy v2.1 FINAL Page 12 of 23

13 It appeared that more than one reviewer performed study selection. Assessment of study quality: No formal validity assessment was described, but some aspects of study quality were described (whether the study was controlled, randomisation and how patients were allocated to treatment). The authors did not state how many reviewers assessed study validity. Data extraction: Outcomes that related to skeletal muscle morphology and biochemistry, cardiovascular and haemodynamic responses, metabolic responses and aerobic fitness changes, bone mineral density and stiffness, functional changes of exercise capacity and psychosocial outlook were extracted. The authors did not state how many reviewers extracted data. Methods of synthesis: The studies were pooled in a narrative synthesis grouped by domains of skeletal muscle morphology and biochemistry. Results of the review: Thirty-two studies (reported in 33 papers) were included in the review (n= 644; range four to 90 patients). One study was a randomised controlled trial (RCT) (n=26) and 31 were randomised or controlled studies (n=618). Positive changes to skeletal muscle morphology and biochemistry in adherents to FES training were reported in one RCT and five randomised or controlled studies. Seven out of nine randomised or controlled studies reported increased aerobic fitness or positive metabolic responses with FES-induced exercise training. Seven randomised or controlled studies showed positive changes in indicators of functional exercise capacity with FES-induced training. One controlled study reported positive effects of FES-induced exercise on depression levels. Changes to heart rate and blood pressure responses were inconsistent during FES-evoked muscle contractions in six controlled or randomised studies. One out of five controlled or randomised studies reported positive effects of FES on bone mineral density; the other studies were equivocal. Authors' conclusions: Available data suggested that FES-evoked leg exercise promoted certain health and fitness benefits for people with spinal cord injury across a variety of outcome domains. CRD commentary: The research question was supported by inclusion criteria for participants, intervention and outcomes; there were none for study design, which may have led to subjective decisions when selecting studies for inclusion. The authors did not report attempts to identify unpublished studies and inclusion was restricted to papers with English abstracts, so publication and language biases could not be ruled out. The review process was not described, so any steps taken to reduce the possibility of reviewer error and bias were unknown. Few aspects of study quality were assessed and so reliability of primary studies was unknown. Participant numbers in included studies were low. Study designs were unclear and few participant details were reported. Narrative synthesis appeared appropriate considering heterogeneity in study designs, interventions and outcomes. Poor reporting of the review process, inclusion of small studies of unknown quality and the possibility of language and publication biases suggests that the authors' conclusions should be treated with caution. 5. LEVEL 1: CRD REVIEW Functional electrical stimulation in the treatment of patients with chronic heart failure: a meta-analysis of randomized controlled trials Sbruzzi G, Ribeiro RA, Schaan BD, Signori LU, Silva AM, Irigoyen MC, Plentz RD CRD summary: This review concluded that functional electrical stimulation may be an alternative therapy for people with chronic heart failure who were unable to perform conventional aerobic exercise. Data came from small studies of low methodological quality. Further research was needed. Given the available data and as they included a need for further research, the conclusions are suitably conservative. Authors' objectives: To assess the effects of functional electrical stimulation in people with chronic heart failure. Searching: MEDLINE, LILACS, PEDro and The Cochrane Library were searched from inception to January Search terms were reported. No language restrictions were applied. GM FES for Foot Drop Policy v2.1 FINAL Page 13 of 23

14 Study selection: Randomised controlled trials (RCTs) that assessed the effects of functional electrical stimulation (FES) in people with chronic heart failure (New York Heart Association Class II, III or IV) were eligible for inclusion. Studies needed to have a follow-up of at least five weeks. The comparator could be conventional aerobic exercise training or control (same regime as the treatment group, but where the intensity of stimulation did not lead to visible or palpable contractions). Application of FES had to be in the quadriceps femoral muscle. Study objectives had to include assessments of peak oxygen consumption (VO2), six-minute walk test or muscle strength. Studies that failed to provide a reliable definition of chronic heart failure were excluded. Most participants were men. Mean age ranged from 53 years to 63 years. All participants were on optimal medical therapy for heart failure. FES treatment programmes ranged from 30 to 240 minutes daily (five to seven days per week) for 25 days to 10 weeks. Reviewers made an initial selection of studies that could possibly be eligible. Full texts were evaluated by two reviewers independently. Disagreements were resolved by consensus. Assessment of study quality: Quality was assessed independently by two reviewers using items such as concealment of allocation, intention-to-treat analysis, baseline comparability, outcomes assessment blinding and description of losses to follow-up and exclusions. Quality was summarised using PEDro and Jadad scales. Data extraction: Data were extracted to enable calculation of mean changes between baseline and end of treatment, and subsequent mean differences in changes, between treatment and comparison groups. Two reviewers independently extracted data. Authors were contacted for further information. Methods of synthesis: Pooled weighted mean differences (WMD) were calculated using a fixed-effect model. Heterogeneity was assessed using Cochran's Q test and I2 statistic. Where insufficient data were available, narrative results were provided. Sensitivity analyses were undertaken based on quality factors. Analysis was redone using a random-effects model. Results of the review: Seven RCTs (224 participants) were included. Study size ranged from 24 to 46 participants. Five trials (168 participants) used conventional aerobic exercise as comparator and two trials (56 participants) used a control treatment The quality of most studies was poor: on the Jadad scale one scored 3, four scored 2 and two scored 1 (out of a maximum of five); on the PEDro score two studies scored 6, two scored 5, two scored 4 and one scored 2 (out of a maximum of 10). Compared to conventional aerobic exercise, FES was associated with less favourable change in peak VO2 (-0.74mL/kg per minute, 95% CI to -0.10, I2-0%; five trials). There was no difference in muscle strength (two trials). A small increase in six-minute walk test was neither statistically nor clinically significant (I2=41%, five trials). Compared to control treatment, FES was associated with an increase in VO2 (2.78mL/kg per minute, 95% CI 1.44 to 4.13, I2=52%; two trials). Two trials reported that there was a statistically significant change in the six-minute walk test with FES, but not with the control treatments. No data were available for muscle strength. The overall low quality of trials precluded planned sensitivity analyses. Use of random-effects models gave results similar to those in the main analyses (data not presented). PEDro: A scale to measure the quality of reports of randomised controlled trials indexed on PEDro, the Physiotherapy Evidence Database. The Jadad scale assesses the quality of published clinical trials based methods relevant to random assignment, double blinding, and the flow of patients. There are 7 items. The last 2 attract a negative score, which means that the range of possible scores is 0 (bad) to 5 (good): Authors' conclusions: FES may be an alternative to conventional aerobic exercise training for those people who are unable to perform these types of exercise; data came from small studies of low methodological quality and further research is needed. CRD commentary: The aims of this review were clearly stated in terms of the inclusion criteria. The search covered a number of relevant sources. There were no language restrictions, which reduced the GM FES for Foot Drop Policy v2.1 FINAL Page 14 of 23

15 risk of language bias. It was unclear whether non published trials were eligible, and it may be that publication bias affected the review. The methods of study selection, data extraction and quality assessment aimed at reducing reviewer error or bias. The quality of included studies was assessed. The methods of synthesis appeared appropriate. Heterogeneity was assessed, but evident heterogeneity in some outcomes was not investigated. As the authors commented, available data came from small studies of generally low quality. Their conclusions, which include a need for further research, are suitably conservative. 6. LEVEL N/A: RAPID APPRAISAL NWCSU Evidence Review: Functional electrical stimulation bicycle for patients with spinal cord injury Date: November 2014 Full review available on request from: policyfeedback.gmcsu@nhs.net Spinal cord injury - prevalence It is estimated that 40,000 people in the UK are affected by SCI (BMJ Best Practice). The majority of them will have incomplete SCI. Men and younger people are more at risk (with road traffic accidents being a major cause), although falls in older people also constitute a substantial risk. FES bicycle FES applies a current to paralysed muscles to stimulate movement, despite a loss of voluntary muscle control. NWCSU has undertaken previous evidence reviews of FES for upper and lower limbs. The requested FES bicycle (RT300 from Cyclone) stimulates a cycling movement and can be used from a wheelchair; this particular machine also has an upper torso device which can be used for arm cycling (without FES). FES in SCI is primarily seen as a tool to counteract the deleterious effects of SCI.(1) Context Southport and Ormskirk NHS trust is home to the Regional Spinal Injuries Centre. The Centre has one FES bike for inpatients only. On enquiring from the requestor, she is aware that two other patients who have asked for CCG funding, have received funding for FES bikes at home from the Regional Centre (see exchange in the case file). The Cyclone (supplier) website mentions Community Cycling Centres which have FES bikes. The nearest to Greater Manchester seems to be a private physiotherapy clinic in Rotherham. The clinic provides physiotherapist assessments, and persons deemed suitable to exercise on the FES bike can do so for 40/hour. Search question parameters Population = People with spinal cord injuries Intervention = FES cycle Comparator: none required Outcomes: Overall health (including quality of life); any changes in health outcomes; clinical benefit. Search Strategy ("FES" OR "functional electr* stimulation") AND ("bike" OR "cycling" OR "bicycle" OR "cycle" OR "RT300") AND (spinal OR SCI) Excluded Studies on patients with other conditions, including stroke; urinary function as outcome; short-term laboratory-based outcomes (e.g. blood parameters, muscle response during exercise only, i.e. without follow-up); single case reports; studies where it was not clear that FES cycling was involved; dosing studies (i.e. comparing different strengths of FES cycling without a no-fes comparison group). Limitations GM FES for Foot Drop Policy v2.1 FINAL Page 15 of 23

16 This rapid review relies mainly on information from published abstracts. Due to the large number of lowlevel studies identified, not all, but most, are represented in the results tables below. However, other studies reviewed show similar results. Search results Database NICE NHS Evidence SIGN Cochrane Library York CRD BMJ Clinical Evidence BMJ Best Practice Medline / EMBASE / CINAHL / AMED Result Nil found 20 records Nil found 30 records 13 records Not searched Not searched 219 records Summary of the evidence A large number of relevant low-level studies (mostly case series) were identified, but few studies of higher level, with relatively small sample sizes. The main outcomes reported were cardiovascular measures, bone mineral density, muscle strength/volume, and general fitness. Several systematic reviews have been identified, but many of them are not limited to FES cycling, and they too rely on the same limited evidence base. Their conclusions suggest that FES cycling can provide some benefits in terms of (cardiovascular) fitness, bone mineral density, oxygen uptake, and muscle strength, and a potential to reduce secondary complications. Hybrid (i.e. arm and leg) exercise seems to confer greater benefit than leg exercise alone. Conclusions need to be interpreted very cautiously in the light of the quality of underlying evidence. 7. LEVEL N/A: RAPID APPRAISAL NWCSU Evidence Review: Functional electrical stimulation for the treatment of cauda equine pain, Date: June 2014, Full review available on request from: policyfeedback.gmcsu@nhs.net Functional electrical stimulation: A technique that uses electrical currents to activate nerves innervating extremities affected by paralysis resulting from spinal cord injury, head injury, stroke and other neurological disorders. Cauda Equina syndrome (CAS): A serious neurological condition affecting the bundle of nerve roots at the lower end of the spinal cord. It is due to a nerve compression that an acute loss of function of the lumbar plexus occurs which stops the sensation and movement. The syndrome is characterized by dull pain in the lower back and upper buttocks and a lack of feeling in the buttocks, genitalia and thigh, together with the disturbance of bowel and bladder function. Cauda equina syndrome occurs in approximately 2% of cases of herniated lumbar discs. Percutaneous electrical nerve stimulation: An enhanced and newer type of pain management therapy that makes use of very thin needles (much like those in acupuncture) that are inserted in the lower back by the chiropractor. Small, battery-powered TENS units also are available for use at home, work, or other activities. Search Strategy A search was made for FES and pain (and cauda equine) GM FES for Foot Drop Policy v2.1 FINAL Page 16 of 23

17 Database Result NICE Nil for FES and pain but an IPG for PENS was found cited below for info CG88 not cited here as does not cover FES for CAS NHS Evidence SIGN Cochrane York BMJ Clinical Evidence BMJ Best Practice General Search (Google) All papers relating to FES were for foot drop Guidance for foot drop in stroke patients only not cited Electrical stimulation for preventing and treating post-stroke shoulder pain, Price CIM, Pandyan AD, Published Online: 8 October 2008 Nil found Nil found Nil found Papers relating to foot drop and shoulder pain only Medline / Open Athens Open Athens Ovid on line search returned no results Open Athens search of all BMJ journals returned no results Provider and associated website Provider assessment pathway and Odstock medical information booklet neither includes cauda equine syndrome as a condition for the use of FES Summary of the evidence There is no evidence available for the use of FES in pain associated with cauda equine syndrome. Most of the evidence related to its use in foot drop of central neurological origin and in neuropathic shoulder pain post stroke (the evidence for which is limited a review is cited below for information on FES and pain relief but does not directly relate to the requested use of the therapy). PENS (Percutaneous Electrical Nerve Stimulation) has been assessed by NICE for use in pain relief guidance cited below for info but should be used by specialist in pain management. The Salisbury Centre (Odstock medical base) suggest its use in spinal compression above T12 cauda equine syndrome is associated with lumbar disc herniation. This treatment does not appear to be indicated for this condition other forms of electrical stimulation e.g. PENS/TENS may be suitable but this condition is not specifically covered by the NICE IPG for back pain which recommends not using TENS as a therapy for low back pain. 8. LEVEL N/A: RAPID APPRAISAL NWCSU Evidence Review: Functional electrical stimulation (FES) for the upper limb, Date: 21 October 2014, Full review available on request from: policyfeedback.gmcsu@nhs.net What is it? Functional electrical stimulation: A technique that uses electrical impulses to activate nerves innervating extremities affected by paralysis resulting from spinal cord injury, head injury, stroke and other neurological disorders. Electrodes are usually placed on the skin close to the nerve supplying the muscle, and leads connect the electrodes to a stimulator producing the impulses. Search Strategy Search terms used were Functional electrical stimulation OR FES ) AND ( arm OR upper OR shoulder ). For the search of the Medline, Embase, and AMED and CINAHL databases, the publication year was restricted to 2013 onwards, as there is a 2013 review from Stockport PCT available. GM FES for Foot Drop Policy v2.1 FINAL Page 17 of 23

18 Only studies reporting on the effectiveness of FES in upper limb conditions were included. Studies aimed at improving cardiovascular function or bone density were excluded, as were studies of implanted prostheses, and brain-machine interface systems. Database NICE Result No results NHS Evidence SIGN Brain Injury Rehabilitation in Adults Guidelines SIGN Management of Patients with Stroke Guidelines Treating patients with hemiplegic shoulder pain, Snels et al 2002 (Review) LinkFrom=OAI&ID= #.VD17Xo10zrc Electrical stimulation for preventing and treating post-stroke shoulder pain, Price at al 2000 (Cochrane review) SIGN Cochrane York BMJ Clinical Evidence BMJ Best Practice Medline / Embase / AMED / CINAHL Nothing additional to the above Nothing additional to the above Nothing additional to the above No results Not searched Publication year 2013 onwards; applicable results included in results table below. Summary of the evidence There is little additional evidence to the 2013 review by Stockport PCT; nearly all the 2013 and 2014 studies identified in bibliographic databases are on stroke patients (see table). Trials are small, they use varied approaches to FES, or other treatments in combination with FES, and varied outcome parameters. Limited evidence suggests that FES may be effective for some outcomes relating to upper limb function in this patient group. No recent studies of FES to upper limbs of patients with brain injury have been identified. Limitations This is a rapid review, limited to reviewing English-language abstracts of published studies. 9. LEVEL N/A: RAPID APPRAISAL Stockport CCG Evidence Review: Functional electrical stimulation (FES) for the treatment of arm muscle paralysis, Date: February 2013, Full review available on request from: policyfeedback.gmcsu@nhs.net SUMMARY OF THE EVIDENCE Please note that this is not a comprehensive systematic review. Information has been extracted from abstracts only and no critical appraisal of the papers included has been undertaken. FES of the upper limb for the purposes of exercising a patient with a spinal cord injury to improve cardiovascular function or bone density has not been included in this evidence summary. GM FES for Foot Drop Policy v2.1 FINAL Page 18 of 23