Selective dorsal rhizotomy for spasticity in cerebral palsy (interventional procedure consultation document)

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NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Selective dorsal rhizotomy for spasticity in cerebral palsy

Selective dorsal rhizotomy is a surgical procedure aimed to ease muscle rigidity and improve mobility in patients with cerebral palsy. The operation involves cutting some of the nerves in the spine that are responsible for muscle rigidity.

The National Institute for Health and Clinical Excellence is examining insertion of pleuro-amniotic shunt to drain fetal pleural effusion and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about SDR for spasticity in cerebral palsy.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

comments on the preliminary recommendations
the identification of factual inaccuracies
additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 27 June 2006
Target date for publication of guidance: September 2006

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

1	Provisional recommendations

1.1	Current evidence on the safety of selective dorsal rhizotomy (SDR) for spasticity in cerebral palsy appears adequate; however, there is evidence of only limited efficacy. Therefore, the procedure should not be used without special arrangements for consent and for audit or research.

1.2	Clinicians wishing to undertake SDR for spasticity in cerebral palsy should take the following actions. Inform the clinical governance leads in their Trusts. Ensure that patients or their parents/carers understand the potential complications associated with this procedure, and also that the procedure is irreversible. Clinicians should also provide patients with clear written information. In addition, use of the Institute's Information for the public is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). Audit and review clinical outcomes of all patients having SDR for spasticity in cerebral palsy.
1.3	Patient selection should be carried out in the context of a multidisciplinary team with specialist expertise in various treatment options for spasticity in patients with cerebral palsy. This should normally include a physiotherapist, a paediatrician, an orthopaedic surgeon and a neurosurgeon.
1.4	Further evidence on the efficacy outcomes of the procedure will be useful. The Institute may review the procedure upon publication of further evidence.

2	The procedure

*2.1*	*Indications*

2.1.1	Cerebral palsy can result from various disease processes that affect the brain, either during gestation or in early childhood. About 75% of patients with cerebral palsy have lower-limb spasticity (increased muscle tone and rigidity). Cerebral palsy may also be associated with movement or balance abnormalities and speech or visual difficulties.
2.1.2	Current conservative treatment options include oral medication, orthotic devices and physiotherapy. Corrective orthopaedic procedures, such as a tenotomy, may be appropriate for some patients. Electrical stimulation, continuous intrathecal baclofen infusion and intramuscular injection of botulinum toxin are other treatment options.



*2.2*	*Outline of the procedure*

2.2.1	The nerve centres in the brain that normally control muscle tone (tension) can be affected by cerebral palsy and in these patients muscle tone depends greatly on a sensory-motor reflex arc between muscles and spinal cord nerves. In this reflex arc, sensory nerves bring information from a muscle to the spinal cord, and spinal cord motor nerves send information back to the muscle, causing it to contract (that is, a spastic reflex). The aim of SDR is to down-regulate this spastic reflex by reducing its sensory input.
2.2.2	SDR is a surgical procedure on the lower spine, carried out under general anaesthesia. The operation takes about 5 hours. An incision is made along the lower back and a laminectomy is made in one or more vertebrae to uncover and then test the small nerve rootlets that make up the spinal sensory nerves. Usually three to five rootlets are identified and those that are found to have abnormal electromyographic responses intra-operatively are selectively cut. All motor nerve rootlets are preserved so that leg movement is not affected.
2.2.3	Patients require intensive physiotherapy for 3-12 months after the procedure; patients who were previously able to walk have to learn to walk again.



*2.3*	*Efficacy*

2.3.1	A meta-analysis of three randomised controlled trials comparing physiotherapy and SDR with physiotherapy alone found that, compared with physiotherapy alone, gross motor function improved by an additional 4% with physiotherapy and SDR (8% and 4% improvements, respectively; p = 0.008). The follow-up period in the primary studies was 9-12 months.

2.3.2	In a non-randomised controlled trial of 61 patients undergoing SDR, injection of botulinum toxin type A or rehabilitation therapy, walking speed scores at 20 months' follow-up were not significantly different from baseline in any of the three groups. However, patients treated by SDR showed a transient but significant decrease in walking velocity at 3 months compared with baseline.
2.3.3	In a non-randomised controlled study, the measure of gross motor performance of 18 children undergoing SDR was found to have increased at 2 years' follow-up (from 54.6 to 63.4 points). This was not significantly different from the improvement among children having corrective orthopaedic surgery (54.1 to 60.7 points) (p = 0.751).
2.3.4	Case series of children with cerebral palsy who received SDR reported that median muscle spasticity scores (Ashworth scale) in abductor muscles decreased from 2 at baseline to 0 at 12 months' post-procedural follow-up among both walkers (p = 0.007) and non-locomotors (defined as non-crawlers and non-walkers) (p = 0.001), and from 2.9 to 0.4 points in a mixed cohort of children with spasticity at 4 years. In another case series, 81% (169/208) of children with cerebral palsy who underwent SDR showed improvements in ambulatory function at 12 months' follow-up. For more details, refer to the sources of evidence (see appendix).
2.3.5	A number of Specialist Advisors commented that there is some controversy about the role of SDR in relation to other management options for spasticity in cerebral palsy. They also commented that a reduction in spasticity does not always result in improved motor function.


*2.4*	*Safety*

2.4.1	A case series of 250 children undergoing SDR (follow-up for at least 2 years in 49 children) reported that 58% (145/250) experienced severe postoperative pain and 40% (100/250) complained of dysaesthesia.
2.4.2	Common bowel and bladder complications reported were constipation in 20% (49/250) of patients, and urinary retention in between 5% (13/250) and 10% (20/208) of patients. Other less common but more serious complications reported were intraoperative bronchospasm in 5% (13/250) of patients, and postoperative aspiration pneumonia in 1% (2/208 and 3/250 in two different studies).
2.4.3	Radiologically observed scoliosis was found in 6% (12/208) of children followed up for up to 4.2 years, although this was not considered to be functionally important. In one case series, periods of increased spasticity during times of increased stress, months or years after surgery, were reported in 40% (100/250) of patients who had undergone SDR. For more details, refer to the sources of evidence (see appendix).
2.4.4	The Specialist Advisors noted that adverse events included bladder and bowel disturbances, limb weakness, joint subluxation, progressive scoliosis or kyphosis, and sensory disturbance. They also noted that theoretical adverse events included paralysis, dividing the wrong nerve rootlets, hypotonicity, weight gain and death.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
June 2006

Appendix:

Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

Interventional procedure overview of selective dorsal rhizotomy for spasticity in cerebral palsy, February 2006

Available from: www.nice.org.uk/ip318overview

This page was last updated: 30 March 2010