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Spinal Cord Stimulation

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • Patient Selection

    Criteria

    The overall goal for patient selection for spinal cord stimulation is to choose those patients most likely to experience therapeutic success while reducing the likelihood of risks, complications, and adverse events. A careful assessment by a multidisciplinary team, and discussion of the patient’s expectations and goals, will help identify appropriate candidates for spinal cord stimulation.

    Spinal cord stimulation may be used to address chronic neuropathic pain – pain resulting from damage to, or dysfunction of, the peripheral or central nervous system.

    Spinal cord stimulation is used to treat chronic pain associated with the following conditions:

    • Radiculopathy secondary to FBS or herniated disk
    • Postlaminectomy pain
    • Epidural fibrosis
    • Degenerative disc disease
    • Causalgia
    • Failed back surgery syndrome
    • Complex regional pain syndrome
    • Arachoiditis

    Many patients have mixed pain for which either neurostimulation or intrathecal drug delivery may be applied. As a result, if a patient does not respond well to neurostimulation, he or she may be a candidate for intrathecal drug delivery.


    Criteria for Spinal Cord Stimulation

    Spinal cord stimulation may benefit certain patients who meet the following criteria:

    • Chronic, intractable pain for more than 6 months
    • Objective evidence of pathology concordant with pain complaint
    • Lack of adequate relief from more conventional treatments
    • Initial or further surgical intervention not indicated
    • No contraindications to therapy or surgery
    • Patient can properly operate system
    • Patient understands therapy risks
    • Therapy and function goals have been established
    • Satisfactory results from screening test
    • Patient is not pregnant
    • No untreated drug habituation
    • Clearance and completion of psychological evaluation
    • 18 years of age or older
       

    Patient Assessment

    Appropriate patient selection is critical for success of the spinal cord stimulation therapy and increased patient satisfaction. The patient selection phase for spinal cord stimulation involves assessment of a patient’s clinical conditions and psychosocial situation by multidisciplinary team members.

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    Tips for Success with Spinal Cord Stimulation: Patient Selection

    (2:50, 17 MB)

    Ralph Rashbaum, MD, talks about patient selection as the most important prescription for success with neurostimulation therapy.


    Key Steps in Patient Selection for Spinal Cord Stimulation

    The key steps involved with patient selection for spinal cord stimulation are:

    • Pain interview
    • Psychological evaluation
    • Patient and caregiver education of therapy
    • Screening test

    Pain Interview

    Managing a patient’s pain entails a complete evaluation of the pain and the patient’s medications. The value of a multidisciplinary approach to assess chronic pain cannot be overstated.

    During the pain interview:

    • Obtain patient history and conduct physical examination
    • For referral patients, confirm accuracy of pain information in patient file
    • Determine the patient’s pain type, pattern, and duration
    • Establish how the patient's pain changes with shifts in position
    • Gather information about how the pain is affecting the patient’s quality of life
    • Establish spinal cord stimulation therapy goals

     

    Psychological Evaluation

    A psychological evaluation using validated assessment tools such as the MMPI, is used to explore contributing factors of the pain.

    The evaluation:

    • Helps reveal complex factors that contribute to pain
    • Helps select the right treatment for managing the pain and related symptoms (e.g., fatigue, depression)
    • May increase the probability of a successful outcome by providing treatments that may resolve psychological risk factors
    • Helps assess patient response during spinal cord stimulation screening test
    • Identifies and treats psychological co-morbidities prior to therapy
    • Evaluates patient willingness, understanding, and competency to actively participate in their spinal cord stimulation therapy
    • Establishes a baseline against which to measure improvement

    Patient and Caregiver Education of Therapy

    Patient and caregiver education is critical to managing patient expectations and the long-term success of spinal cord stimulation. Education begins at the initial assessment and continues throughout all phases of spinal cord stimulation. Equally important to the clinical selection of the patient, is the time to allow the patient to make an educated decision concerning his or her therapy. 

    Discussion about spinal cord stimulation can help the patient to:

    • Reduce anxiety about the procedures
    • Participate effectively during the spinal cord neurostimulation screening test
    • Understand and observe self-care responsibilities necessary for therapy success
    • Understand safety and risk information necessary for informed consent

    It is important that the patient understands:

    • Goal of spinal cord stimulation is to manage rather than eliminate pain
    • Of patients who benefit from spinal cord stimulation, some have reported a reduction in their pain of 50% or more1
    • For some patients, a lower reduction in pain is considered successful because certain activities are able to be resumed
    • They may require adjuvant medical treatment (e.g., medication)
    • Their role in adjusting stimulation to address changes in pain with shifts in body position

     

    Screening Trial

    Measurement tools are used to evaluate if the screening trial outcome was successful and if the patient is a candidate for an implanted spinal cord stimulation system. Measurement tools include:

    • Diary – patient entries showing pain level scores
    • Parameter settings – data gathered by the external trialing system (external power source and implanted lead) including amplitude, pulse width, and rate
    • Medication changes – the need for systemic analgesics
    • Positional assessment – effect on therapy coverage as patients change positions

    Results of the screening trial should be assessed against goals established before the test by the patient, the patient's family and caregivers, and the pain management team:

    • Pain relief – To what degree did the screening trial relieve the patient's pain? How much was therapy coverage affected when patient changed positions?
    • Functional improvement – To what degree did the screening trial improve the patient's ability to participate in typical activities?
    • Sleep – Did the patient's sleep improve during the screening trial?
    • Medication – Did the need for systemic analgesics decrease during the screening trial?
    • Satisfaction – Is the patient comfortable with the level of pain relief and preferred sensation?

    In case of marginal outcome, determine if:

    • Patient's pain type is unresponsive to spinal cord stimulation
    • Patient had unrealistic expectations
    • Other issues outweighed the benefit of spinal cord stimulation
    • Spouse or caregiver has input on screening trial effectiveness

    A spinal cord neurostimulation system implant is not recommended when:

    • Infection is present
    • Screening trial goals were not met
    • Patient cannot properly operate the screening system

     

    References
    1. Kumar K, Taylor RS, Jacques L et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain 2007;132:179-188.

    Screening Trial

    A screening trial provides the opportunity to assess the effectiveness of spinal cord stimulation for chronic pain without making a long-term commitment. The screening trial lasts 3 to 7 days and uses an external trialing system. Components of the system include test or percutaneous leads; the Multi-Lead Trialing Cable; and an external trialing neurostimulator. The external neurostimulator and the implantable neurostimulator produce comparable symptom suppression when set to the same parameters.

    A helpful tool for identifying the need for programming adjustments is the positional assessment form. Patients can track how therapy coverage is affected when changing body position.

    SelectStim Screening Trial

    The SelectStimSM Screening Trial allows patients to experience a full range of programming options available with Medtronic spinal cord stimulation. Patients can try multiple stimulation options with high density (HD) and low density (LD) settings to determine which settings help relieve their pain. The trial results from this full range of settings help predict the right dose of pain relief.

    At least two groups should be programmed for the screening trial: one with HD settings, and one with LD settings. Additional HD settings and LD settings are optional.

    Use the resources below to educate patients about changing from one group to another and help them record their response to the different groups throughout the screening trial. Tracked results will inform the most effective stimulation option when the SCS system is implanted.

    Patient Worksheet for the SelectStim Screening Trial
    Give this to patients who are undergoing the SelectStim Screening Trial. It allows them to write comments about each group to compare and contrast their responses to multiple settings throughout the trial. The worksheet also includes instructions for using the MyStim® programmer during the SelectStim Screening Trial.

    Screening Trial Guide and Patient Diary
    Give this to patients to help them understand how to use the trial neurostimulation system, record goals for the trial, track pain before the trial, and record activities and pain levels during the trial.

    Clinician SelectStim Screening Trial Worksheet
    Use this editable PDF to record LD and HD parameter settings for patients undergoing the SelectStim Screening Trial.

    Screening Trial Procedure

    To prepare for the screening trial, 1 or more leads are placed into the epidural space. The clinician programs the portable external neurostimulator to generate the electrical pulses that produce the desired stimulation.

    Refer to the Percutaneous Lead Implantation Guide for detailed information and procedures for the spinal cord stimulation screening trial using percutaneous leads.

    Role of Patient During the Screening Trial

    During the screening trial, the patient uses the spinal cord neurostimulation trial system while completing daily activities. In some cases, the patient can use a patient control device to change some stimulation settings within physician-programmed limits.

    Throughout the screening trial, the external neurostimulator collects patient-use data. In addition, the patient records activities, stimulation settings, and degree of pain relief in a diary. After the screening trial, the results are evaluated to determine if the patient is a candidate for the second stage, a spinal cord stimulation system implant.

    Evaluation of Screening Trial Results

    Measurement tools are used to evaluate if the screening trial outcome was successful and if the patient is a candidate for an implanted spinal cord stimulation system. Measurement tools include:

    • Diary – patient entries showing pain level scores
    • Parameter settings – data gathered by the external trialing system (external power source and implanted lead) including amplitude, pulse width, and rate
    • Medication changes – the need for systemic analgesics
    • Positional assessment – effect on therapy coverage as patients change positions

    Results of the screening trial should be assessed against goals established before the test by the patient, the patient's family and caregivers, and the pain management team:

    • Pain relief – To what degree did the screening trial relieve the patient's pain? How much was therapy coverage affected when patient changed positions?
    • Functional improvement – To what degree did the screening trial improve the patient's ability to participate in typical activities?
    • Sleep – Did the patient's sleep improve during the screening trial?
    • Medication – Did the need for systemic analgesics decrease during the screening trial?
    • Satisfaction – Is the patient comfortable with the level of pain relief and preferred sensation?

    In case of marginal outcome, determine if:

    • Patient's pain type is unresponsive to spinal cord stimulation
    • Patient had unrealistic expectations
    • Other issues outweighed the benefit of spinal cord stimulation
    • Spouse or caregiver has input on screening trial effectiveness

    A spinal cord neurostimulation system implant is not recommended when:

    • Infection is present
    • Screening trial goals were not met
    • Patient cannot properly operate the screening system

     

    United States