Bedfordshire and Hertfordshire Priorities Forum guidance
Subject: Use of Functional Electrical Stimulation
Number: 59
Date of decision: December 2010
Date of review: December 2014
Guidance
Overall recommendation
Functional Electrical Stimulation for neurological conditions will not be routinely
funded due to a lack of evidence of clinical and cost effectiveness.
Current practice/relevant comparators
Treatment options include physiotherapy or an ankle-foot orthosis to align the lower leg and
control the motion of the ankle and foot, providing stability and improving gait. Medical therapy
includes oral administration of muscle relaxant drugs or botulinum toxin type A injections.
Surgery (usually reserved for refractory cases) includes selective tendon release of muscles.
Natural history of the disease/ prognosis, survival
FES has been proposed for a number of neurological disorders in upper limbs and lower
limbs, as set out below. These are, in general, long-term conditions with a disease course
specific to the underlying condition.
Explanation of drug/technology

FES is a means of producing contractions in muscles, paralysed due to central nervous
system lesions, by means of electrical stimulation. Applications are found in stroke, spinal
cord injury, head injury, cerebral palsy, multiple sclerosis and other neurological
conditions, whether congenital or acquired. The electrical stimulation is applied either by
skin surface electrodes or by implanted electrodes.
Motor dysfunction in the upper and/or lower limbs is a common complication of a number
of neurological disorders. In the upper limb, it can lead to painful subluxation of the
shoulder and problems with shoulder, elbow, wrist and hand movement. In the lower limb,
drop-foot resulting from peroneal nerve damage causes abnormal gait, reduced walking
speed and increased risk of falls.
Epidemiology
There is no good estimate of the numbers affected in Derbyshire County, but it could be up to
5,000 new patients per year.
Evidence of clinical and cost effectiveness

There has been a number of trials into the effectiveness of electrical stimulation in limb
dysfunction and several recent systematic reviews. All published clinical studies have
substantial methodological weaknesses. Positive outcomes have been shown for shoulder
pain/subluxation, range of movement and motor function in the upper limb and for walking
speed in the lower limb. However, these outcomes were not consistent across all studies
and were limited by problems with study design. The significance of some outcomes
measured, e.g. walking speed, and their impact on quality of daily life are unclear.

Most published evaluations of FES have shown positive results although benefits were
often not observed at longer-term follow-up. However, the identified trials are generally
small and of low methodological quality. Studies lack descriptions of randomisation
methods, blinding and intention-to-treat analyses. They also vary in the patient groups
studied and the exact nature of the intervention. Although suggestive at least of short-term
benefit, the evidence to date is insufficient to comment reliably on the effectiveness of
FES for people with motor dysfunction.

There is a lack of studies comparing electrical stimulation with other rehabilitation
modalities including various forms of physiotherapy, orthoses and interventions to reduce
spasticity. The place of electrical stimulation in pathways for rehabilitation is therefore
unclear. It is not currently possible to identify any sub-groups of patients who would derive
particular benefit from electrical stimulation compared to other interventions.

FES is not mentioned in The National Service Framework for Long-Term Conditions.

NICE IPG 278 states that “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.
1.2 Patient selection for implantable FES for drop foot of central neurological
origin should involve a multidisciplinary team specialising in rehabilitation.
1.3 Further publication on the efficacy of FES would be useful, specifically
including patient-reported outcomes, such as quality of life and activities of daily
living, and these outcomes should be examined in different ethnic and
socioeconomic groups.”
The NICE Clinical Guidelines on the management of Multiple Sclerosis refer to FES only
in the context of the management of urinary incontinence.
Evidence of cost effectiveness
There are currently no studies that examine the cost effectiveness of FES.
References
1. The National Service Framework for Long-Term Conditions.
2. NICE IPG 278: Functional electrical stimulation for drop foot of central neurological origin
3. NICE Clinical Guidelines on the management of Multiple Sclerosis
4. Review articles: Minimizing fatigue for functional electrical stimulation of muscle. Clinical
Rehabilitation, Vol. 3, No. 4, 333-340 (1989)
5. Functional electrical stimulation for limb motor dysfunction following stroke. Thomas Dent.
STEER 2001; Vol 1: No.16
6. Clinical Policy Bulletin: Functional Electrical Stimulation and Neuromuscular Electrical
Stimulation. AETNA
7. South Central Priorities Committees (Buckinghamshire/Milton Keynes PCTs) Policy
Statement 75: Electrical Stimulation (including Functional Electrical Stimulation) for Upper
and Lower Limb Dysfunction: May 2008
Acknowledgements: Adopted from NHS Derbyshire County
The Human Rights Act has been considered in the development of this guidance