1. Spinal Cord Stimulators and Failed Back Syndrome
Mark Stern, MD
Neurosurgeon

2. Topics Part 1: Chronic Pain Conditions
Part 2: Spinal Cord Stimulation (SCS)/ Neurostimulation
Part 3: Prevention and Management of Neurostimulation Complications
Part 4: Intrathecal Drug Delivery (IDD)

3. Types of Neuropathic Pain
Direct nerve root injury: radiculopathy
Battered root syndrome
Perineural fibrosis
Intrafascicular fibrosis
Adhesive arachnoiditis
Peripheral deafferentation
Phantom limb pain
Sympathetic-mediated pain syndrome
Herpetic neuralgia
Diabetic polyneuropathy
Central deafferentation-thalamic stroke
Here are some examples of neuropathic pain.
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg

4. Types of Nociceptive Pain
Mechanical low back pain
Discogenic pain
Joint pain
Facet joint
Sacroiliac joint
Pseudoarthrosis
Osteoporosis
Musculoskeletal trauma
Here are some examples of nociceptive pain.
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg

5. Combined Nociceptive and Neuropathic Pain
Failed Back Surgery Syndrome (FBSS)*
Idiopathic chronic pain syndrome
Cancer pain
*Also referred to as “post-surgical chronic back pain”
Some pain exhibits characteristics of both nociceptive and neuropathic pain.
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg

6. Chronic Pain Conditions
Post-surgical chronic back pain or failed back
Radicular pain syndrome or radiculopathies resulting in pain secondary to failed back or herniated disk
Postlaminectomy pain
Multiple back operations
Unsuccessful disk surgery
Degenerative disk disease, herniated disk pain refractory to conservative and surgical interventions
Peripheral causalgia
Epidural fibrosis
Arachnoiditis or lumbar adhesive arachnoiditis
Complex regional pain syndrome, reflex sympathetic dystrophy or causalgia
[Speak to the slide.]

7. Device therapies are now considered earlier in the treatment continuum
Pain Treatment Ladder
Device therapies are now considered earlier in the treatment continuum
The Stamatos version of the Pain Treatment Ladder proposes focusing on the area causing the pain, rather than treating the whole body.
In contrast to the traditional treatment ladder approach, interventional therapies, corrective surgery, and neurostimulation are placed before long-term opioid therapy.
This allows targeting of medication or therapy to the specific area of pain before a more general pain treatment approach is applied.
Stamatos JM, et al. Live Your Life Pain Free, October Based on the interventional pain management experience of Dr. John Stamatos

8. Part 2: Spinal Cord Stimulation / Neruostimulation

9. Spinal Cord Stimulation: Indication
Patient Selection for Spinal Cord Stimulation
Spinal Cord Stimulation: Indication
To aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
MR ©2016 Medtronic, Inc. All Rights Reserved.
MR Copyright Medtronic, Inc. All Rights Reserved.

10. Choosing Candidates for Spinal Cord Stimulation
Patient Selection for Spinal Cord Stimulation
Choosing Candidates for Spinal Cord Stimulation
Indicated for spinal cord stimulation (SCS) system as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions:
Failed Back Syndrome (FBS) or low back syndrome or failed back
Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk
Postlaminectomy pain
Multiple back operations
Unsuccessful disk surgery
Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions
Peripheral causalgia
Epidural fibrosis
Arachnoiditis or lumbar adhesive arachnoiditis
Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia
MR Copyright Medtronic, Inc. All Rights Reserved.

11. Choosing Candidates for Spinal Cord Stimulation
Patient Selection for Spinal Cord Stimulation
Choosing Candidates for Spinal Cord Stimulation
Chronic, intractable pain1
Objective evidence of pathology2
Lack of adequate relief from conventional treatments3
Initial or further surgical intervention not indicated3
At least 18 years of age2
Patient can properly operate the system2
Patient understands therapy risks2
Satisfactory screening test results2
Patient is not pregnant2
Completion of psychological evaluation3
Chronic, intractable pain
Objective evidence of pathology
Lack of adequate relief from conventional treatments
Initial or further surgical intervention not indicated
At least 18 years of age -
Patient can properly operate the system-
Patient understands therapy risks
Satisfactory screening test results
Patient is not pregnant
Completion of psychological evaluation
Medtronic, Inc. Indications, Implantable Neurostimulation Systems
Medtronic, Inc. Medtronic Pain Therapy: Information for Prescribers
Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7). Published August 7, Available at: Accessed May 19, 2016.
MR Copyright Medtronic, Inc. All Rights Reserved.

12. Failed Back Surgery Syndrome (FBSS)
Patient Selection for Spinal Cord Stimulation
Failed Back Surgery Syndrome (FBSS)
Defined as persistence or development of low back or leg pain following surgery on the lumbosacral spine
Most common indication for neurostimulation therapy for chronic pain in the United States
FBSS occurs in patients who have typically undergone multiple lumbosacral spine operations for conditions such as disk herniation, lumbar stenosis, or spinal instability1,2,3,4
Approximately 300,000 back surgeries are performed in USA/year to treat chronic lumbar pain5
Failure rates as high as 40%5
Success rate decreases significantly with each subsequent back surgery 6
The two most common indications for SCS therapy are Failed Back Surgery Syndrome and Complex Regional Pain Syndrome. As a beginner, these predominant pain conditions should be your primary area of focus.
 Failed Back Surgery Syndrome is defined as the persistence or development of low back or leg pain following surgery on the lumbosacral spine and is the most common indication for neurostimulation therapy for chronic pain in the United States.
Failed Back Surgery Syndrome occurs in patients who have typically undergone multiple lumbosacral spine operations for conditions such as disk herniation, lumbar stenosis, or spinal instability. Approximately 300,000 back surgeries are performed in the United States each year to treat chronic lumbar pain. Failure rates are as high as 40% and the success rate decreases significantly with each subsequent back surgery.
Patients with Failed back Surgery Syndrome have failed to obtain long-term pain relief, even after treatment with a variety of therapies, including oral medications, nerve blocks, corticosteroid injections, physical therapy, chiropractic care, fixation surgeries and repeated surgeries. If these treatments are unsuccessful, neurostimulation may be an excellent alternative option.
MR Copyright Medtronic, Inc. All Rights Reserved.

13. Complex Regional Pain Syndrome (CRPS)
Patient Selection for Spinal Cord Stimulation
Complex Regional Pain Syndrome (CRPS)
Second most common use of neurostimulation therapy for chronic pain in the United States is for the symptomatic management of complex regional pain syndrome (CRPS)
CRPS is a neuropathic pain syndrome precipitated most commonly by minor limb trauma1,2,4
Continuous, severe pain, disproportionate to the inciting event, occurs in the limb and may be accompanied by allodynia, hyperalgesia, skin color changes, edema, joint stiffness, and bone demineralization1,2,3,4
Type I (reflex sympathetic dystrophy)
Minor injuries or fractures of a limb precede the onset of symptoms
Type II (causalgia)
Develops after injury to a major peripheral nerve
The second most common indication for SCS therapy for chronic pain in the United States is for the symptomatic management of complex regional pain syndrome or CRPS.
CRPS is a neuropathic pain syndrome precipitated most commonly by minor limb trauma and presents with continuous, severe pain, disproportionate to the inciting event. CRPS occurs in the limb and may be accompanied by allodynia, hyperalgesia, skin color changes, edema, joint stiffness, and bone demineralization. Type I CRPS, also called reflex sympathetic dystrophy, results from minor injuries or fractures of a limb which precede the onset of symptoms. Type II CRPS, or causalgia, develops after injury to a major peripheral nerve.
MR Copyright Medtronic, Inc. All Rights Reserved.

14. Contraindications for Spinal Cord Stimulation
Patient Selection for Spinal Cord Stimulation
Contraindications for Spinal Cord Stimulation
Diathermy- Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted electrodes, resulting in severe injury or death.
Refer to the package labeling for a complete list of indications and contraindications for comprehensive details regarding product safety.
MR Copyright Medtronic, Inc. All Rights Reserved.

15. Potential Benefits of Spinal Cord Stimulation
Patient Selection for Spinal Cord Stimulation
Potential Benefits of Spinal Cord Stimulation
Long-term pain relief1,2
Improved quality of life1,2
More effective than repeat surgery for persistent radicular pain after lumbosacral spine surgery3
Successful pain disability reduction2
More cost-effective than conventional medical management and reoperation4,5
Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary in the course book for important risk and safety information
Percentage of Patients with FBSS Who Achieved ≥50% Pain Relief at 24 Months1
MR Copyright Medtronic, Inc. All Rights Reserved.

16. Medtronic Registry Product Performance-related Events for SCS1
Patient Selection for Spinal Cord Stimulation
Medtronic Registry Product Performance-related Events for SCS1
Leada,b
Lead migration/dislodgements (n=314)
High impedance (n=78)
Lead fracture (n=46)
Undesirable change in stimulation (n=43)
Medical device complication (n=25)
Low impedance (n=17)
Device malfunction (n=11)
Neurostimulatorc
Medical device complication (n=3)
Device malfunction (n=2)
Undesirable change in stimulation (n=2)
High impedance (n=1)
Paresthesia (n=1)
Recharging unable to recharge (n=1)
Broken bond wire (n=1)
a leads followed from June 2004 through July 31, 2013
b. Includes events with 5 or more occurrences
c neurostimulators followed from June 2004 through July 31, 2013
For a complete list of adverse events which have been associated with SCS, refer to the manufacturer labeling for the specific device.
1. Medtronic Product Performance Report 2013.
MR Copyright Medtronic, Inc. All Rights Reserved.

17. Importance of Patient Selection
Patient Selection for Spinal Cord Stimulation
Importance of Patient Selection
Appropriate patient selection is critical for:
Therapy success
Patient satisfaction
Goal of patient selection
Choose patients most likely to experience therapeutic success
Minimize likelihood of risks, complications, and adverse events
There are many factors that contribute to the success of neurostimulation and Targeted Drug Delivery. However, appropriate patient selection is one of the most critical factors for therapy success and patient satisfaction.
The overall goal of patient selection is to choose patients most likely to experience therapeutic success while minimizing the likelihood of risks, complications, and adverse events.
Some critical components of patient selection include a pain interview and physical exam, therapy goal identification and documentation, a psychological evaluation, and patient education.
MR Copyright Medtronic, Inc. All Rights Reserved.

18. Part 3: Prevention and Management of Neurostimulation Complications

19. Complications in Neurostimulation for Chronic Pain
SCS Complications
Complications in Neurostimulation for Chronic Pain
Preoperative considerations
Intraoperative considerations
Postoperative considerations
MR12169

20. SCS Complications
Preoperative
MR12169

21. Informed Consent: Risks
SCS Complications
Informed Consent: Risks
Undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking
Hematoma
Epidural hemorrhage
Paralysis
Seroma
CSF leakage
Infection
Erosion
Allergic response
Hardware malfunction or migration
Pain at implant site
Loss of pain relief
Chest wall stimulation
Surgical risks
Consider risks common to both trial and implant procedure.
Focus on risks with implantation including early and late complications.
Stress early recognition and management.
For additional safety information, please refer to the brief summary of safety information at
For current product advisories, refer to
MR12169

22. Informed Consent Discussion
SCS Complications
Informed Consent Discussion
Risk-based discussion
Discuss both early and late complications
Provide information on the frequency and severity of event, identifying those which are most common, and how the events may be prevented or managed
For example:
Post dural puncture headache
Risk of dural puncture
Results from CSF leakage from dural insult (needle or lead)
Generally requires epidural blood patch
Autologous blood injected into the epidural space at the puncture site
Infection
Bleeding
Neurologic injury - Paresthesia
Inability to access the epidural space
MR12169

23. Physiological Considerations
SCS Complications
Physiological Considerations
Difficult Anatomy
Scoliosis, Morbid Obesity, Prior Surgery
Inability to access the epidural space or place the lead
Pacemaker Implantation
Need for intra-op and post-op cardiac monitoring
Recommendation for pacemaker representative involvement
Infection
History of MRSA
Systemic vs. local infection
Diabetes
SMOKING
Anticoagulation
Future medical requirements (ie, MRI compatibility)
Clear discussion of possibility of not being able to access the epidural space or the inability to steer the lead in the epidural space and inability to achieve adequate paresthetic coverage.
Need for preoperative medical clearance including consideration for routine screening diagnostics for remote or systemic infection.
Need for close perioperative control of blood sugars for diabetics.
Consideration for smoking cessation prior to SCS trial and implantation.
MRI – device selection and MDT being the only company to have FDA approval for a MR Conditional system to allow safe MRI scans anywhere in the body.*
*Under specific conditions and requires SureScan implantable neurostimulator and Vectris leads. Refer to approved labeling for full list of conditions.
MR12169

24. SCS Complications
Intraoperative
MR12169

25. Intraoperative Considerations
SCS Complications
Intraoperative Considerations
Needle insertion angle (< 45)
Dural puncture
LOR to air
Pneumocephalus
Lead placement
Intrathecal
Anterior epidural
Lateral epidural
Anchoring
Strain relief loop of lead
Strict hemostasis
IPG placement
Depth and anchoring
Wound closure
MR12169

26. Postoperative Hardware Biological Stimulation SCS Complications
Let’s take a look at the most common and severe complications and the ranges associated with each.
Medtronic used a wide array of articles to provide a fair balance of the rate ranges for the most common risks captured in our labeling. This is not inclusive of all data available nor does it reflect all complications experienced and we strongly suggest that you review the literature for yourself.
The rates listed in the tables include a rate range for each complication based on that review.
MR12169

27. Incidence of Hardware Complications1
SCS Complications
Incidence of Hardware Complications1
n= 42 to 2972
Complication
Rate*
Lead migration1,2,4,5,7,8,9
4.89% to 22.6%
Loose connection 2,7,10
0.58% - 9.5%
Lead wire breakage 1,2,4,5,7,8,10
0.58% - 9.1%
Hardware malfunction 1,2,5,7,10
2.0% - 13%
Battery failure 1,2,9
0.92% - 1.6%
Stress the importance of implanter technique in minimizing migration and fracture which will be discussed in subsequent slides. Needle angle, anchoring technique, strain relief loop of lead, IPG location, intraoperative testing of impedances.
*Rate is based on the number of subjects implanted.
MR12169

28. Incidence of Biologic Adverse Events
SCS Complications
n= 42 to 2972
Incidence of Biologic Adverse Events
Complication
Rate*
Infection 1,2,4,5,10
4.5 to 10.0%
Pain over implant site 1,3,4,5,10
0.6 – 16.32%
Erosion 1
0.58%
Allergic reaction 1,3,4,5,9
0.58 – 5.95%
Hematoma 2,5,9
0.28 – 3.1%
Cerebrospinal Leak1,2,9
0.3 – 2.8%
Seroma 1,3,4,10
0.2 – 4.0%
Paralysis 6
˂ 1 in 10,000
Infection is generally limited to superficial, but can result in epidural abscess or meningitis.
Deep infection generally requires explantation.
Erosion and allergic reaction have rare reported incidence of < 1%.
Parapalegia was reported by Meglio in 1989 and resulted from an infection.
Cerebrospinal may include dural tear.
Paralysis: Although rare, Medtronic has identified 14 reports over the last 30 years describing delayed spinal cord compression due to an epidural mass around a Medtronic SCS lead. All patients had neurological deficits and required surgical intervention to remove the mass. The severity ranged from muscle weakness to progressive quadriparesis. In several of the cases, only one side of the body was affected. The appearance of neurological symptoms was often preceded by a loss of therapy effect. The reported outcomes in these patients were full recovery (9 reports), permanent impairment (2 reports), and unknown (3 reports). There has not been a report of a patient death associated with this issue. It is important to be aware of this rare but severe complication since Awareness of this adverse event can lead to early detection and prevention of permanent neurological impairment. The Safety Alert can be accessed on the Product Advisory website listed on slide 5. {This text is pulled directly from the safety alert excluding the last sentence)
Epidural Hemmhorage has not been reported but is listed as a potential risk in labeling.
Note: Epidural Hemorrhage has not been reported in this cited literature, but is listed as a potential risk in labeling
*Rate is based on the number of subjects implanted.
MR12169

29. Incidence of Stimulation Complications
SCS Complications
n= 42 to 2972
Incidence of Stimulation Complications
Complication
Rate*
Loss of Pain Relief 1
12.71%
Undesirable stimulation 1,3,4,5,9
1.36 – 12.0%
Chest wall stimulation3,4,5
0.58%
Chest wall stimulation have rare reported incidence of < 1%.
Chest wall stimulation was reported in one patient during the Itrel 3 study.
*Rate is based on the number of subjects implanted.
MR12169

30. Best Practices to Minimize and manage Complications
SCS Complications
Best Practices to Minimize and manage Complications
MR12169

31. Minimizing Infection Several weeks before surgery
SCS Complications
Minimizing Infection
Several weeks before surgery
Manage coexisting conditions & risks
Control blood glucose
Recognize and treat remote infections
Consider consultation with an infectious disease specialist
Reduce or eliminate smoking
Manage anticoagulation
Discuss surgical risks and management with the patient
1-2 days before surgery
Patient instructed to bath/clean surgical sites with a antimicrobial scrub
Follett KA, Boortz-Marx RL, Drake JM, et al
MR12169

32. SCS Complications
Minimizing Infection
Perioperative: 1 hour, administer prophylactic antibiotic1 Intraoperative1,2
Operating room
Drape fluoroscopic C-arm within sterile field
Limit entry & exit to OR
During procedure
Minimize number of people
Double-glove, minimal touch
Strict hemostasis
Minimize tissue trauma
Patient prep
Scrub with antiseptic solution
Use antimicrobial incision drape
Drape large sterile field
Closing the incision
Suture in anatomical layers
Apply sterile occlusive dressing
1Follett KA, Boortz-Marx RL, Drake JM, et al
2Deer TR, Stewart CD
MR12169

33. Device Selection and Implant Techniques
SCS Complications
Device Selection and Implant Techniques
Complications that may be minimized through device selection and implant technique best practices
Undesirable stimulation
Lead migration
Lead wire breakage
Connection problems
Kumar K, Buchser E, Linderoth B, et al
MR12169

34. Minimizing Undesirable Stimulation with RestoreSensor ® and AdaptiveStim ®
AdaptiveStim technology addresses these needs by automatically changing amplitude as needed in appropriate patients
RestoreSensor with AdaptiveStim
Automatically detects changes in body position
Adapts stimulation settings
to patient preferences
up to 6 positions
Clinical Study related to positional changes
Study patients exposed to stimulation with and without AdaptiveStim
87.3% (62) preferred AdaptiveStim*
90.1% (64) intended to use AdaptiveStim*
all or most of the time
or to turn on/off as needed
*Schultz D, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician.
2012;15:1-12.
MR12169

35. Implant Technique: Minimizing Lead Migration and Wire Breakage
SCS Complications
Implant Technique: Minimizing Lead Migration and Wire Breakage
Lead placement1
Patient prone, pillow
Conscious sedation
Both AP & lateral images
Adequate length for lead & extension
Percutaneous lead
Needle entry: paramedian oblique, less than 45o angle1
Soft silicone anchor2
Anchor end is pushed through fascia2
A shallow angle, less than 45° of introduction, facilitates lead steering and helps minimize the potential for compression of neural structures as a result of bending of the relatively stiff lead.
Medtronic Injex Anchor is soft silicone and provides consistent lead retention across the entire length of the anchor without undue stress on the lead; also maintains lead integrity without using screws or springs that could fail.
InjexTM Anchors
1Kumar K, Buchser E, Linderoth B, et al
2Henderson JM, Schade CM, Sasaki J, et al
MR12169

36. SCS Complications
Implant Technique: Minimizing Lead Migration and Wire Breakage (continued)
Strain relief loop1
Nonabsorbable sutures2
Circular loop1, greater than 2 cm diameter
Surgical lead: instead of anchor1
Percutaneous lead: between anchor and extension1
Neurostimulator in abdominal wall1
Minimize distance between lead anchor and IPG, avoid significant rostral caudad distances
1Kumar K, Buchser E, Linderoth B, et al
2Henderson JM, Schade CM, Sasaki J, et al
MR12169

37. Implant Technique: Minimizing Connection Problems
SCS Complications
Implant Technique: Minimizing Connection Problems
Use adequate length for lead & extension
Some physicians prefer a longer lead to avoid a lead-extension connection1
Tighten setscrews securely; use appropriate wrench
Protect connections from body fluids
Lead to extension - use tissue adhesive in boot2
Neurostimulator
eg, Make sure self-sealing grommet closes after wrench removed
1Renard VM, North RB
2Kumar K, Wilson JR, Taylor RS, et al
MR12169

38. Minimizing Pain and Skin Erosion at Anchor & Extension Connection
SCS Complications
Minimizing Pain and Skin Erosion at Anchor & Extension Connection
Select appropriate anchor1
Anchor at unobstructed location1
Not over bony structures
Secure anchor to deep fascia
Bury extension connector in an existing pocket (anchor or neurostimulator)2
Not in a new pocket
InjexTM Bi-wing Anchor
1Kumar K, Wilson JR, Taylor RS, et al
2 Renard VM, North RB
MR12169

39. Minimizing Pain and Skin Erosion at Neurostimulator Site
SCS Complications
Minimizing Pain and Skin Erosion at Neurostimulator Site
Neurostimulator location
Away from obstructions1,2
eg, not over rib cage; avoid belt line and other clothing restrictions
No deeper than specified in product labeling
Neurostimulator pocket
Blunt dissection
Snug fit2
Secure neurostimulator
Stress marking and agreeing upon the implant site.
Show the patient the size of the implanted equipment preoperatively.
Use suture loops with non-absorbable sutures to avoid movement and flipping.
Avoid excess dead space to prevent seroma and hematoma formation.
Document ability to communicate with neurostimulator before breaking sterile field.
Avoid excess tension on the incisions.
1Kumar K, Wilson JR, Taylor RS, et al
2Follett KA, Boortz-Marx RL, Drake JM, et al
MR12169

40. Management of Postsurgical Complications
SCS Complications
Management of Postsurgical Complications
Complication
Management
CSF leak: dural puncture
Conservative management1
Flat bed rest, hydrate, analgesics
Caffeine
Abdominal binder
Some physicians perform epidural blood patch1
Subcutaneous hematoma (or seroma)
Apply binder2
May resolve spontaneously3
May need to aspirate2,3
1Eldrige JS, Weingarten TN, Rho RH
2Deer TR, Stewart CD
3Kumar K, Wilson JR, Taylor RS, et al
MR12169

41. Management of Postsurgical Complications1
SCS Complications
Management of Postsurgical Complications1
Complication
Management
Pain over component
May improve with conservative measures1
Lidocaine patch
Cushion site
Surgically revise component1
Deeper, if appropriate
Away from irritation
Skin erosion over component
Revise component 2
Deeper, if appropriate1
Consider antibiotics
1Deer TR, Stewart CD
2Follett KA, Boortz-Marx RL, Drake JM, et al
MR12169

42. Management of System Complications
SCS Complications
Management of System Complications
Complication
Management
Lead migration
Reprogram
Revise surgically
Lead wires broken
Replace lead
Hardware malfunction
Replace component
Undesirable paresthesia
Depending on cause:
Educate patient
Battery failure
Loose connection
Compare lead location to intraoperative radiographs.
Visualize system for obvious migration and fracture.
Perform impedance check on the system to diagnose lead failure.
MR12169

43. Part 4: Intrathecal Drug Delivery (IDD)

44. Intrathecal Drug Delivery (IDD) Therapy
IDD therapy involves the delivery of pain medicine in the intrathecal space
The pump is connected to a thin, flexible catheter; both are implanted under the skin
Smaller doses of medication are needed for effective pain relief because drug is delivered directly to the pain receptors
Intrathecal drug delivery (IDD) uses a drug delivery system to place medication directly to the intrathecal space of the spine.
IDD consists of:
A round pump device that stores and delivers pain medication
A catheter that is connected to the pump and inserted into the spine

45. Synchromed® II Drug Infusion System Indications
Chronic intrathecal infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain
Also indicated for chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for severe spasticity, chronic epidural infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, and chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain
When being used for chronic pain, the pump can be filled with:
Preservative-free morphine
Ziconotide sterile solution
Lioresal® is a registered trademark of Novartis Pharmaceuticals, Inc.

46. Approximate Equivalent Daily Doses of Morphine
Route of Administration
Relative Potency (mg)*
Oral
Intravenous
Epidural
Intrathecal
300
100 20 1
Intrathecal Drug Delivery can provide significant pain control with a small fraction of the dose (as little as 1/300th) that would be required with oral medications. This helps minimize side effects.
*Relative approximations based on clinical observations

47. Benefits of IDD Therapy
Pain relief for patients who have not received adequate relief with conventional therapies
Reduction in adverse effects from oral opioids such as nausea, vomiting, sedation, and constipation
Decreased or elimination of oral analgesics
Increased ability to perform activities of daily living
Patient control within physician-set limits
May be effective for patients who do not experience relief from neurostimulation therapy
[Speak to the slide. Emphasize that because the drug is delivered directly to the intrathecal space, IDD offers significant pain control with lower doses of medication.]
Lamer TJ: Mayo Clin Proc. May 1994;69(5): ; Paice JA, et al: J Pain Symptom Manage.1996;11(2):71-80.

48. IDD Trial
The purpose of the trial is to assess the efficacy and side effects of intrathecal morphine
Trialing methods include
Continuous epidural
Continuous intrathecal
Bolus epidural
Bolus intrathecal
Patients who report at least 50% reduction in pain may be candidates for long-term therapy
Candidates for IDD undergo a trial procedure to predict success with an implanted pump.
During the trial, patients should experience at least a 50% reduction in pain, without intolerable side effects to the test drug, to be considered for the therapy.

49. IDD Therapy Risks Programming error Drug concentration error
Surgical complications, such as infection
Catheter could become dislodged or blocked
The pump could stop working
Other side effects may occur
[Speak to the slide.]
For complete list of risks/complications, refer to product package insert
Onofrio BM, Yaksh TL. J Neurosurg 1990;72: ; Winkelmueller M, Winkelmueller W. J Neurosurg 1996;85: ; Paice JA, Penn RD, Shott S. J Pain Symptom Manage 1996;11(2):71-80.

50. Patient Selection

51. Indications for Neurostimulation and Intrathecal Drug Delivery Therapy
Neurostimulation and Intrathecal Drug Delivery are indicated for a variety of chronic pain conditions.
A number of conditions can be treated with neurostimulation or intrathecal drug delivery. As a result, if a patient does not respond well to neurostimulation, IDD can be applied.
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362. Refer to full prescribing information for Medtronic Neurostimulation Systems and Synchromed® II and Isomed® Drug Infusion Systems

52. Patient Selection Considerations
Patients who have neuropathic pain in a concordant anatomic distribution respond best to neurostimulation (NS) therapy
Patients who have nociceptive pain in a concordant distribution respond best to Intrathecal Drug Delivery (IDD)
Patients who do not respond well to NS may be candidates for IDD therapy
[Speak to the slide. Stress the final bullet point.]
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.

53. Patient Selection Checklist
Failure of oral/transdermal opiate use or undesirable side effects
More conservative therapies have failed
An observable pathology exists that is concordant with the pain complaint
Further surgical intervention is not indicated
No serious untreated drug habituation exists
Psychological evaluation and clearance for implantation has been obtained
No contraindications to implantation exist
Appropriate patients will have experienced inadequate pain relief and/or intolerable side effects from more conservative therapies.
A psychological evaluation should reveal a patient’s true expectations of the therapy.
After fulfilling the criteria listed above, the patient proceeds to a trial. This test helps predict success of the therapy.
Refer Patient for a Pain Therapy Trial
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.

54. Neurostimulation Clinical Evidence
Both neurostimulation and intrathecal drug delivery have been thoroughly studied. We’ll begin with clinical evidence for neurostimulation.

55. Medtronic PROCESS Study
Primary outcome
Number of patients with ≥50% leg pain relief at 6 months (≥50% reduction in leg VAS)
Secondary outcomes evaluated at 1, 3, 6, 9, 12, 18 and 24 months
Pain relief (leg and axial back VAS)
Quality of life (SF-36 and EQ-5D)
Function (Oswestry Disability Index)
Patient satisfaction
Need for drug or non-drug therapy for pain
Time away from work
Adverse events
The PROCESS study was a Medtronic-sponsored study completed in [confirm].
[Speak to the slide.]
Kumar, et al. Pain 2007

56. Clinically Significant Leg Pain Relief
Key Findings: ≥50% leg pain relief at 24 months, continued greater effect with SCS* in the per treatment/ITT analyses over 24 months *SCS (spinal cord stimulation) is a term for neurostimulation
[Speak to the slide.]
Kumar, et al. Pain 2007; n = 100

57. Significant Improvement in Function
[Speak to the slide.]
Key Findings: Significant improvement in function (Oswestry Disability Index) in SCS+CMM group over 24 months
Kumar, et al. Pain 2007; n = 100

58. Significant Improvement in Quality of Life
Visual Analog Scale (VAS)
Key Findings: Significant improvement in SCS+CMM group in 7/8 domains of QoL (SF-36) over 24 months
[Speak to the slide. Stress mental health, role-emotional and general health results.]
Kumar, et al. Pain 2007

59. High Satisfaction
Key Findings: Treatment satisfaction among patients continuing SCS+CMM at 24 months
At 24 months, 93% of the 42 patients continuing SCS+CMM declared that “based on their experience so far, they would have agreed to treatment.”
Kumar, et al. Pain 2007; n = 100

60. Long-Term Pain Relief Key Findings:
61.3% of failed back surgery syndrome patients with bilateral limb pain and 59.3% of patients with unilateral limb pain reported >50%
[Speak to the slide.]
Kumar, et al. Neurosurgery 2006

61. Neurostimulation is Most Effective When Considered Early
Success Rate (%)
[Stress difference in success rate at two years compared to 15 years.]
<2
2-5
5-8
8-11
11-15
>15
Kumar K, et al. Neurosurg. 2006;58;

62. More Effective than Repeat Surgery
Key Findings:
Among patients available for long-term follow up, SCS was significantly more successful than reoperation: 9 (47%) of 19 patients randomized to SCS and 3 (12%) of 26 patients randomized to reoperation achieved at least 50% pain relief and were satisfied with treatment
[Speak to the slide.]
North, et al. Neurosurgery 2005 ; n=45

63. 10-Year Experience: Neurostimulation Improves Quality of Life
27%
30%
42%
44%
[Speak to the slide. Stress increase in independence and ability to relax.]
Van Buyten J-P, et al. Eur J Pain 2001;5: ; n=125 pain cases; P<0.01 for all activities

64. Intrathecal Drug Delivery Clinical Evidence
Following is clinical evidence pertaining to Intrathecal Drug Delivery.

65. Back and Leg Pain Relief
Key Findings:
Numeric back pain ratings decreased >48%, and leg pain ratings decreased by 32% at 12-month follow up
[Speak to the slide.]
Deer, et al. Pain Medicine 2004; n=136

66. Successful Disability Reduction
Key Findings:
Successful disability reduction was reported in 60% of patients at 6 months and in 66% at 12 months
[Speak to the slide.]
Deer, et al. Pain Medicine 2004; n=136

67. Decreased Use of Pain Medications
88.2% of patients were taking systemic opioids at baseline
Key Findings:
At 6 months, 65% of patients decreased their use of systemic opioids from baseline
At 12 months, 42% of patients decreased their usage compared with the 6-month follow up
[Speak to the slide.]
Deer, et al. Pain Medicine 2004; n=136

68. Overall Global Pain Relief
Number of Patients
Global Pain Relief (%)
Key Findings:
Overall pain relief of ≥50% was reported by 82% of patients (40 of 49)
[Speak to the slide.]
Roberts, et al., European Journal of Pain; n=88

69. Clinical Evidence Risks
As with any surgical procedure, neurostimulation and IDD involve the risk of infection. Lead migration is the most common complication associated with neurostimulation,1 while intrathecal catheters can fracture, kink, and migrate.2 For a complete list of adverse events for implantable therapies, see the appropriate product labeling.
[Speak to the slide.]
1. Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review
J Neurosrug (Spine 3) 100: , 2004; 2. Staats P. Complications of intrathecal therapy. Pain Medicine 2008; 9(S1):S102-S107

70. Summary
With today’s treatments, patients should not have to wait for effective pain relief
By partnering, we can help patients find the right pain treatment
Together we can improve the quality of life for chronic pain patients
Our decisions may change the course of a patient’s life
Working as a team, we are able to treat all aspects that factor into the patients’ pain experience: health, injury, emotional, family, community and psychosocial.
Together we can improve the quality of life for chronic pain patients and our decisions may change the course of their lives.

71. Case Study Male, 45, office manager, no major psychosocial issues
One spine surgery to treat herniated disc
Referred from primary care physician to address axial back pain and secondary radicular pain that persists six months following anatomically corrective surgery
Average back pain score (VAS) of 80/100 with diminished functional capacity
Relief from physical rehabilitation therapy was not satisfactory
Unsuccessfully treated with neuropathic pain agents and two systemic opioids, patient experienced extreme sedation and constipation
Treated with nerve block series but relief was temporary
Our final discussion point is the case study outlined above.