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Spinal Cord Stimulation

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

    There are many factors critical to the success of spinal cord stimulation. One of the most important is 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
    • 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)
    • Not all patients prefer paresthesia over pain

    Screening Test

    Measurement tools are used to evaluate if the screening test 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 test 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 test relieve the patient's pain? How much was therapy coverage affected when patient changed positions?
    • Functional improvement – To what degree did the screening test improve the patient's ability to participate in typical activities?
    • Sleep – Did the patient’s sleep improve during the screening test?
    • Medication – Did the need for systemic analgesics decrease during the screening test?
    • Satisfaction – Is the patient comfortable with the sensation of paresthesia?

    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 test effectiveness

    A spinal cord neurostimulation system implant is not recommended when:

    • Infection is present
    • Screening test 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 Test

    A screening test provides the opportunity to assess the effectiveness of spinal cord stimulation for chronic pain without making a long-term commitment. The screening test lasts 3 to 7 days and uses an external trialing system. Components of the system include test, percutaneous, or surgical 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.

    Screening Test Procedure

    To prepare for the screening test, 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 Surgical Lead Implantation Guide or the Percutaneous Lead Implantation Guide for detailed information and procedures for the spinal cord stimulation screening test using surgical or percutaneous leads, respectively.

    Role of Patient During the Screening Test

    During the screening test, 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 test, 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 test, 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 Test Results

    Measurement tools are used to evaluate if the screening test 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 test 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 test relieve the patient's pain? How much was therapy coverage affected when patient changed positions?
    • Functional improvement – To what degree did the screening test improve the patient's ability to participate in typical activities?
    • Sleep – Did the patient’s sleep improve during the screening test?
    • Medication – Did the need for systemic analgesics decrease during the screening test?
    • Satisfaction – Is the patient comfortable with the sensation of paresthesia?

    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 test effectiveness

    A spinal cord neurostimulation system implant is not recommended when:

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

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