In The Lupe

In the Lupe, Episode 13 Description on PodBean 

​ 

 Patel, Kiran V. "Dorsal Root Ganglion Stimulation for Chronic Pelvic Pain [39T]." Obstetrics & Gynecology 133 (2019): 223S. 

Abbott Proclaim Implantable Pulse Generator Clinician’s Manual. Plano, TX. 2019. 

 

*These are the experiences of these patients. Individual experiences, symptoms, situations and results may vary 

 

Rx Only Brief Summary:  Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system. 

DRG 

Indications for Use:  

US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.** 

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study. 

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). 

International: Management of chronic intractable pain.  

Contraindications:  

US: Patients who are unable to operate the system, who are poor surgical risks. Patients who have failed to receive effective pain relief during trial stimulation. 

International: Patients who are unable to operate the system, are poor surgical risks, are pregnant, or under the age of 18.  

Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive and flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery, equipment and vehicles, pediatric use, pregnancy, and case damage.  

Adverse Effects: Unpleasant sensations, changes in stimulation, stimulation in unwanted places, lead or implant migration, epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, cerebrospinal fluid leakage, tissue damage or nerve damage, paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, pain where needle was inserted or at the electrode site or at IPG site, seroma at implant site, headache, allergic or rejection response, battery failure and/or leakage. Clinician’s Manual must be reviewed for detailed disclosure. 

Abbott One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000 Neuromodulation.Abbott 

™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner. © 2021 Abbott. All Rights Reserved. 

MAT-2104565 v1.0 | Item is approved for global use.

Chapman KB, Mogilner AY, Yang AH, et al. Lead migration and fracture rate in dorsal root ganglion stimulation using anchoring and non-anchoring techniques: A multicenter pooled data analysis. Pain Practice : the Official Journal of World Institute of Pain. 2021 Jun. DOI: 10.1111/papr.13052.

Rx OnlyBrief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system.

DRG

Indications for Use:

US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).

International: Management of chronic intractable pain.

Contraindications:

US: Patients who are unable to operate the system, who are poor surgical risks. Patients who have failed to receive effective pain relief during trial stimulation.

International: Patients who are unable to operate the system, are poor surgical risks, are pregnant, or under the age of 18.

Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive and flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery, equipment and vehicles, pediatric use, pregnancy, and case damage.

Adverse Effects: Unpleasant sensations, changes in stimulation, stimulation in unwanted places, lead or implant migration, epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, cerebrospinal fluid leakage, tissue damage or nerve damage, paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, pain where needle was inserted or at the electrode site or at IPG site, seroma at implant site, headache, allergic or rejection response, battery failure and/or leakage. Clinician’s Manual must be reviewed for detailed disclosure.

AbbottOne St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000Neuromodulation.Abbott

™ Indicates a trademark of the Abbott group of companies.‡ Indicates a third party trademark, which is property of its respective owner.© 2021 Abbott. All Rights Reserved.

MAT-2104565 v1.0 | Item is approved for global use.

Rx OnlyBrief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system.

AbbottOne St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000Neuromodulation.Abbott

™ Indicates a trademark of the Abbott group of companies.‡ Indicates a third party trademark, which is property of its respective owner.© 2021 Abbott. All Rights Reserved.

MAT-2102124 | Item approved for global use.

Dr. Timothy Lubenow and Dr. Jason Pope had too much to talk about when it comes to Radiofrequency - Listen now to Radiofrequency round 2 to continue the discussion on Radiofrequency in your practice.

IonicRF Generator Clinician’s Manual. Plano, TX. 2020.

MINT study (In the Lupe 10): Juch, Johan NS, et al. "Effect of radiofrequency denervation on pain intensity among patients with chronic low back pain: the mint randomized clinical trials." Jama 318.1 (2017): 68-81.

Pope mention of retrospective study (In the Lupe 11): Cheng, Jianguo, et al. "Comparative outcomes of cooled versus traditional radiofrequency ablation of the lateral branches for sacroiliac joint pain." The Clinical journal of pain 29.2 (2013): 132-137.

Rx OnlyBrief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system.

Indications for Use: The NT2000iXTM generator is intended for lesioning neural tissue. The NT2000iXTM generator is intended to be used for pain management. The NT2000iXTM generator is to be used only with separately cleared/approved lesion/temperature probes (NeuroTherm radiofrequency probes and SPINECATHTM and ACUTHERMTM catheters). The NT2000iXTM generator is indicated for use in the peripheral nervous system. ​

Warnings/Precautions: Hazardous electrical output, electric shock hazard, explosion hazard, fire hazard, pooling hazard, ignition hazard, fuse replacement, risk of RF burns to patient, interference with active implants, interference with other equipment, probes. User’s Guide must be reviewed for detailed disclosure. ​

Indications for Use:  ​

US: The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is indicated as an aid in the​ management of pain in the nervous system. Examples include facet denervation, trigeminal rhizotomy, and related functional​ neurosurgical procedures.​

International: The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is indicated as an aid in the management of pain in the nervous system. Examples include, but are not limited to, facet denervation, rhizotomy, and related functional neurosurgical procedures.​

Contraindications: The use of this device is contraindicated in patients with systemic infection or local infection in the area of the procedure.​

Warnings/Precautions: Hazardous electrical output, electric shock hazard, equipment failure, explosion hazard, fire hazard, pooling hazard, ignition hazard, risk of RF burns and unintended stimulation, risk of RF burns to patient, interference with active implants, redirection of high-frequency currents, interference with other equipment, shortwave or microwave equipment, apparent low output or failure of equipment, risk of patient injury, proper device use, non-sterile, accessories, continuity monitoring, inspection, mechanical damage, electrode positioning, use of fluids, dispersive connections, cleaning the generator, emergency stop.​

Adverse Effects: Damage to surrounding tissue through iatrogenic injury; nerve injury, including thermal injury, or puncture of the spinal cord or nerve roots, potentially resulting in radiculopathy, paresis, and paralysis; pain, pulmonary embolism, hemothorax or pneumothorax, infection, unintended puncture wound, including vascular puncture and dural tear, hemorrhage, and hematoma. User’s Guide must be reviewed for detailed disclosure.​

AbbottOne St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000Neuromodulation.Abbott

™ Indicates a trademark of the Abbott group of companies.‡ Indicates a third party trademark, which is property of its respective owner.© 2021 Abbott. All Rights Reserved.

MAT-2012731| Item is approved for global use.

Join Drs. Jason Pope and Timothy Lubenow for a new episode of Abbott Virtual Scientific Forum Podcast In the Lupe:  History of Radiofrequency. List to our esteemed faculty discuss the history and importance of utilizing Radiofrequency in your practice day to day.

 

Cohen SP, Bhaskar A, Bhatia A, et al. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med. 2020;45(6):424‐467. doi:10.1136/rapm-2019-101243

Juch, J., Maas, E. T., Ostelo, R., Groeneweg, J. G., Kallewaard, J. W., Koes, B. W., Verhagen, A. P., van Dongen, J. M., Huygen, F., & van Tulder, M. W. (2017). Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back Pain: The Mint Randomized Clinical Trials. JAMA, 318(1), 68–81. https://doi.org/10.1001/jama.2017.7918

Manchikanti L. et al. A systematic review and best evidence synthesis of effectiveness of therapeutic facet joint interventions in managing chronic spinal pain. Pain physician. 2015 Jul;18:E535-82.

 

 

 

 

Rx OnlyBrief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system.

DRG

Indications for Use:

US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).

International: Management of chronic intractable pain.

Contraindications:

US: Patients who are unable to operate the system, who are poor surgical risks. Patients who have failed to receive effective pain relief during trial stimulation.

International: Patients who are unable to operate the system, are poor surgical risks, are pregnant, or under the age of 18.

Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive and flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery, equipment and vehicles, pediatric use, pregnancy, and case damage.

Adverse Effects: Unpleasant sensations, changes in stimulation, stimulation in unwanted places, lead or implant migration, epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, cerebrospinal fluid leakage, tissue damage or nerve damage, paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, pain where needle was inserted or at the electrode site or at IPG site, seroma at implant site, headache, allergic or rejection response, battery failure and/or leakage. Clinician’s Manual must be reviewed for detailed disclosure.

SCS

Indications for Use:

Sp

Join Dr. Lubenow and Dr. Pope for the Abbott Virtual Scientific Forum Podcast, "In the Lupe: Fellow's Tour" where they discuss how Abbott is leading the way in training and education with how Abbott is training fellows on the road this year.

Rx OnlyBrief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system.DRGIndications for Use: US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.***Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study.**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).International: Management of chronic intractable pain.Contraindications: US: Patients who are unable to operate the system, who are poor surgical risks. Patients who have failed to receive effective pain relief during trial stimulation.International: Patients who are unable to operate the system, are poor surgical risks, are pregnant, or under the age of 18.Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive and flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery, equipment and vehicles, pediatric use, pregnancy, and case damage.Adverse Effects: Unpleasant sensations, changes in stimulation, stimulation in unwanted places, lead or implant migration, epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, cerebrospinal fluid leakage, tissue damage or nerve damage, paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, pain where needle was inserted or at the electrode site or at IPG site, seroma at implant site, headache, allergic or rejection response, battery failure and/or leakage. Clinician’s Manual must be reviewed for detailed disclosure.SCSIndications for Use: Spinal cord stimulation 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: failed back surgery syndrome and intractable low back and leg pain.Contraindications: Patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implanted devices, magnetic resonance imaging (MRI), electrosurgery, explosive and flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery, equipment and vehicles, pediatric use, pregnancy, and case damage. Patients who are poor surgical risks, with multiple illnesses, or with active general infections should not be impla

Join Dr. Lubenow and Dr. Pope for the Abbott Virtual Scientific Forum Podcast, "In the Lupe: Industry Partnership" where they discuss the importance on partnering with Industry especially during the educational part of your fellowship. 

References

Proclaim™ DRG Neurostimulation System Clinician’s Manual. Plano, TX. 2018.

Deer TR, Patterson DG, Baksh J, et al. Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation. Neuromodulation. Published online March 23, 2020. doi:10.1111/ner.13143. PMID: 32202044

Diwan, Sudhir, and Timothy R. Deer. Advanced Procedures for Pain Management. Springer International Publishing:, 2018. https://www.springer.com/gp/book/9783319688398

Rx Only

Brief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with needles and electrodes that are compatible with the system.

Indications for Use: The NT2000iX™ generator is intended for lesioning neural tissue. The NT2000iX™ generator is intended to be used for pain management. The NT2000iX™ generator is to be used only with separately cleared/approved lesion/temperature probes (NeuroTherm™ radiofrequency probes and SPINECATH™ and ACUTHERM™ catheters). The NT2000iX™ generator is indicated for use in the peripheral nervous system.

Warnings/Precautions: Hazardous electrical output, Electric shock hazard, Explosion Hazard, Fire Hazard, Pooling Hazard, Ignition Hazard, Fuse Replacement, Risk of RF burns to patient, Interference with active implants, Interference with other equipment, Probes. User’s Guide must be reviewed for detailed disclosure. User’s Guide must be reviewed for detailed disclosure.

DRG

Indications for Use:

US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).

International: Management of chronic intractable pain.

Contraindications:

US: Patients who are unable to operate the system, who are poor surgical risks. Patients who have failed to receive effective pain relief during trial stimulation.

International: Patients who are unable to operate the system, are poor surgical risks, are pregnant, or under the age of 18.

Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive and flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery, equipment and vehicles, pediatric use, pregnancy, and case damage.

Adverse Effects: Unpleasant sensations, changes in stimulation, stimulation in unwanted places, lead or implant migration, epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, cerebrospinal flui

References

Proclaim™ DRG Neurostimulation System Clinician’s Manual. Plano, TX. 2018.

Cameron, Tracy. "Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review." Journal of Neurosurgery: Spine 100.3 (2004): 254-267.

Deer, Timothy R., et al. "The Neurostimulation Appropriateness Consensus Committee (NACC) recommendations for infection prevention and management." Neuromodulation: Technology at the Neural Interface1 (2017): 31-50.

B. North, D. Kidd, J. Shipley and R. S. Taylor, "Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial.," Neurosurgery, vol. 61, no. 2, pp. 361-369, 2007.

Deer TR, Levy RM, Kramer J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 2017;158(4):669-681.

"Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review." Journal of Neurosurgery: Spine 100.3 (2004): 254-267

“The Appropriate Use of Neurostimulation: Avoidance and Treatment of Complications of Neurostimulation Therapies for the Treatment of Chronic Pain.” Deer et al. 2014

“Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Bleeding and Coagulation Management in Neurostimulation Devices.” Deer et al. 2017

https://www.asra.com/asra-news/article/153/prevention-and-treatment-of-infections-d

Peter Staats MD, Richard, North MD, Konstantin Slavin MD, Timothy Deer MD, Kristina Davis PhD, and Chananit Hutson PhD presented this preliminary data at the 21st Annual Meeting of the North American Neuromodulation Society in Las Vegas, NV,USA on January 11–14, 2018.

Diwan, Sudhir, and Timothy R. Deer. Advanced Procedures for Pain Management. Springer International Publishing:, 2018. https://www.springer.com/gp/book/9783319688398

Eldabe, Sam, Eric Buchser, and Rui V. Duarte. "Complications of spinal cord stimulation and peripheral nerve stimulation techniques: a review of the literature." Pain Medicine 17.2 (2016): 325-336.

Deer, Timothy R., et al. "The neuromodulation appropriateness consensus committee on best practices for dorsal root ganglion stimulation." Neuromodulation: Technology at the Neural Interface 22.1 (2019): 1-35.

Bedder, Marshall D., and Helen F. Bedder. "Spinal cord stimulation surgical technique for the nonsurgically trained." Neuromodulation: Technology at the Neural Interface 12 (2009): 1-19.

Horan, Mattias, et al. "Complications and Effects of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Neuropathic Pain: A Nationwide Cohort Study in Denmark." Neuromodulation: Technology at the Neural Interface (2020).

 

*12:06 includes content from the physician speakers experience

**21:55 includes content from the physician speakers experience

 

Rx OnlyBrief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system.

DRG

Indications for Use:

US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic c

In the Lupe, Episode 5

Join Dr. Lubenow and Dr. Pope and Special Guest, Dr. Petersen for the Abbott Virtual Scientific Forum Podcast, "In the Lupe: The Surgeon and Pain Physician Relationship" where they discuss strategies to create and develop a supportive relationship between pain physicians and neurosurgeons.

 

References

Proclaim™ DRG Neurostimulation System Clinician’s Manual. Plano, TX. 2018.

Deer, Timothy R., et al. "The Neurostimulation Appropriateness Consensus Committee (NACC) recommendations for infection prevention and management." Neuromodulation: Technology at the Neural Interface1 (2017): 31-50.

Deer, Timothy R., et al. "The neurostimulation appropriateness consensus committee (NACC) safety guidelines for the reduction of severe neurological injury." Neuromodulation: Technology at the Neural Interface1 (2017): 15-30.

B. North, D. Kidd, J. Shipley and R. S. Taylor, "Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial.," Neurosurgery, vol. 61, no. 2, pp. 361-369, 2007.

 

Rx OnlyBrief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system.

DRG

Indications for Use:

US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).

International: Management of chronic intractable pain.

Contraindications:

US: Patients who are unable to operate the system, who are poor surgical risks. Patients who have failed to receive effective pain relief during trial stimulation.

International: Patients who are unable to operate the system, are poor surgical risks, are pregnant, or under the age of 18.

Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive and flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery, equipment and vehicles, pediatric use, pregnancy, and case damage.

Adverse Effects: Unpleasant sensations, changes in stimulation, stimulation in unwanted places, lead or implant migration, epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, cerebrospinal fluid leakage, tissue damage or nerve damage, paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, pain where needle was inserted or at the electrode site or at IPG site, seroma at implant site, headache, allergic or rejection response, battery failure and/or leakage. Clinician’s Manual must be reviewed for d

References

Proclaim™ DRG Neurostimulation System Clinician’s Manual. Plano, TX. 2018.

Deer TR, Levy RM, Kramer J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 2017;158(4):669-681.

Henderson, Jaimie M., et al. "NANS training requirements for spinal cord stimulation devices: selection, implantation, and follow‐up." Neuromodulation: Technology at the Neural Interface 12.3 (2009): 171-174.

Deer, Timothy R., et al. "The Neurostimulation Appropriateness Consensus Committee (NACC) recommendations for infection prevention and management." Neuromodulation: Technology at the Neural Interface1 (2017): 31-50.

Deer, Timothy R., et al. "The neurostimulation appropriateness consensus committee (NACC) safety guidelines for the reduction of severe neurological injury." Neuromodulation: Technology at the Neural Interface1 (2017): 15-30.

Deer, Timothy R., et al. "The neuromodulation appropriateness consensus committee on best practices for dorsal root ganglion stimulation." Neuromodulation: Technology at the Neural Interface1 (2019): 1-35.

Deer, Timothy R., et al. "Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation." Neuromodulation: Technology at the Neural Interface (2020).

Tavel, Edward, et al. “Programming Optimization Strategies for Burst may Improve Outcomes.” NANS, Las Vegas, USA, 2017.

*Smarter stimulation” described in the podcast at 15:53 is referring to neurostimulation with novel waveforms or parameters, and should not be described as “smart stimulation".

 

Rx OnlyBrief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system.

DRG

Indications for Use:

US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).

International: Management of chronic intractable pain.

Contraindications:

US: Patients who are unable to operate the system, who are poor surgical risks. Patients who have failed to receive effective pain relief during trial stimulation.

International: Patients who are unable to operate the system, are poor surgical risks, are pregnant, or under the age of 18.

Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive and flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery, equipment and vehicles, pediatric use, pregnancy, and case damage.

Adverse Effects: Unpleasant sensations, changes in stimulation, stimulation in unwanted places, le