Neurostimulation of lumbar muscles for refractory non-specific chronic low back pain

Evidence-based recommendations on neurostimulation of lumbar muscles for refractory non-specific chronic low back pain in adults. This involves implanting a pulse generator under the skin of the upper buttock or lower back, which the person can use to manage their pain.

# Recommendations
Evidence on the efficacy and safety of neurostimulation of lumbar muscles for refractory non-specific chronic low back pain is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page.
Clinicians wanting to do neurostimulation of lumbar muscles for refractory non-specific chronic low back pain should:
Inform the clinical governance leads in their healthcare organisation.
Give people (and their families and carers as appropriate) clear written information to support shared decision making, including NICE's information for the public.
Ensure that people (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
Audit and review clinical outcomes of everyone having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion).
Enter details about everyone having neurostimulation of lumbar muscles for refractory non-specific chronic low back pain onto the National Neuromodulation Registry and review local clinical outcomes.
Healthcare organisations should:
Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for everyone having this procedure.
Regularly review data on outcomes and safety for this procedure.
Patient selection should be done by a multidisciplinary team with experience in pain management and neuromodulation stimulation procedures.
Further research should include suitably powered randomised controlled trials comparing the procedure with current best practice with appropriate duration. It should report details of patient selection and long-term outcomes.# The condition, current treatments and procedure

# The condition
Non-specific severe long-term chronic refractory low back pain can present in various ways, including as neuropathic pain (associated with damage to the nervous system) or nociceptive pain (associated with physical damage to joints, muscles and ligaments). In some people, it is associated with dysfunction of the lumbar multifidus (large muscles that support the lower back) and arthrogenic muscle inhibition. This treatment is not intended for neuropathic pain.

# Current treatments
Treatments for low back pain are described in NICE's guideline on low back pain and sciatica in over 16s: assessment and management. Conservative pain management includes pharmacological treatments (such as oral non-steroidal anti-inflammatory drugs, and weak opioids with or without paracetamol) and non-interventional treatments (such as self-management advice and education, exercise, manual therapies, and combined physical and psychological therapy). People with severe chronic low back pain that is refractory to conservative treatments may be offered interventional procedures (such as radiofrequency denervation and epidural injections) or surgery (such as spinal fusion procedures).

# The procedure
The procedure is done under general anaesthesia, or local anaesthesia with sedation. A pulse generator (neurostimulator) is implanted in a pocket created under the skin of the upper buttock or lower back. Under fluoroscopic guidance through a midline approach, 2 stimulating leads are inserted. The distal end of each lead has stimulation electrodes. They are positioned next to the spinal column, near the medial branch of the L2 motor nerve supply (dorsal ramus nerve) to the multifidus muscles, and fixed using flexible tines. The leads are tunnelled internally, then the proximal ends are connected to the pulse generator and the position is checked radiographically.
Approximately 14 days after the implantation procedure, the patient can start to use the device to manage their pain. While lying prone, they use a handheld wireless remote control to deliver stimulation to the nerve supply of the lumbar multifidus muscles, which causes them to contract. This is usually done twice a day for about 30 minutes each time. The pulse generator can be programmed to deliver stimulation between any pair of electrodes on each lead if needed.
The aim of neurostimulation is to help the body regain multifidus neuromuscular control by 'activating' the lumbar muscles and stabilising the spinal column, reducing chronic pain. The procedure is reversible.