If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Providing strain relief. Failure to provide strain relief may result in lead migration requiring a revision procedure.
Anchoring leads. Do not suture directly onto the lead to avoid damaging the lead. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Remove leads slowly.
If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Always perform removal with the patient conscious and able to give feedback. In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system:.
Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion DRG , include pain from setting the stimulation parameters too high. This may occur once the lead is in place and is connected to the neurostimulator and activated. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings.
Additionally, all patients will be awake and conversant during the procedure to minimize the impact. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.
For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation. Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient.
Other active implanted devices. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Interference with other devices. Avoid placing equipment components directly over other electronic devices.
To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it.
For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment. Safety and effectiveness of neurostimulation for pediatric use have not been established. Equipment is not serviceable by the customer. In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this IPG:.
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Not all real-world data came from randomized controlled multicenter clinical studies. References: De Ridder, D. Mimicking the brain: Evaluation of St. Expert Review of Medical Devices,12 2 , Jude Medical. Plano, TX. Oakley, J. Spinal cord stimulation in axial low back pain: Solving the dilemma. Pain Medicine , 7 1 , SS Presented at NANS Burst spinal cord stimulation: toward paresthesia-free pain suppression.
One year follow up. Burst spinal cord stimulation for limb and back pain. World neurosurgery. A prospective, randomised, double-blind, placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the treatment of failed back surgery syndrome.
Burst spinal cord stimulation provides superior overall pain relief compared to tonic stimulation. Pain practice: the official journal of World Institute of Pain.
Burst spinal cord stimulation evaluated in patients with failed back surgery syndrome and painful diabetic neuropathy. A 2-center comparative study on tonic versus burst spinal cord stimulation: amount of responders and amount of pain suppression. Clinical Journal of Pain. Burst stimulation for chronic low back and leg pain. Improved pain and psychosocial function with Burst SCS: 1 year outcomes of a prospective study.
Cervical burst spinal cord stimulation for upper limb chronic pain: A retrospective case series. Deer, T, et. Pain Practice. Published online June 18, Deer T, Levy R, 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. Intended Use This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures.
Contraindications This neurostimulation system is contraindicated for patients who are Unable to operate the system Poor surgical risks Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Warnings The following warnings apply to this neurostimulation system. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: Determine the device type If practical, try to move external devices out of the scan range Ask patients with neurostimulators to shut off the device temporarily while the scan is performed.
Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds.
After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. Have the patient check the device for proper functioning, even if the device was turned off. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan.
During implant procedures, if electrosurgery devices must be used, take the following actions: Use bipolar electrosurgery only. Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.
Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Set the electrosurgery device to the lowest possible energy setting. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Additional Warnings for Leads Conscious sedation.
Precautions The following precautions apply to this neurostimulation system. General Precautions Patient selection. It is extremely important to select patients appropriately for neurostimulation. Thorough psychiatric screening should be performed.
Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted. Implantation of multiple leads. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.
High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. If unpleasant sensations occur, the device should be turned off immediately. Postural changes. However, some patients may experience a decrease or increase in the perceived level of stimulation.
Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising.
If unpleasant sensations occur, the IPG should be turned off immediately. Advise patients about adverse effects. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. Patient training. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system.
Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Battery precaution. The clinician programmer and patient controller contain a battery and other potentially hazardous materials.
Do not crush, puncture, or burn these devices because explosion or fire may result. Return them to Abbott Medical for proper disposal. Stimulation effectiveness. The long-term effectiveness of dorsal root ganglion DRG stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation.
Stimulation effectiveness has been established for one year. Sterilization and Storage Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide EtO gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field.
Do not resterilize or reimplant an explanted system for any reason. Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind.
Handling and Implementation Expiration date. Do not use the system if the use-before date has expired. Package or component damage. Before opening any sterile package, verify the kit model number, that the kit is within its expiration use-before date, and that the packaging has not been damaged or compromised in any way. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient.
Return any suspect components to Abbott Medical for evaluation. Handle the device with care. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Lead inspection. Carefully inspect the lead in the sterile field for damage after removing it from the sterile package.
Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target.
Care and handling of components. During the procedure, the patient is asked if paresthesia elicited by stimulation covers the painful area. If so, electrodes are connected to an external stimulator if a trial phase is deemed needed.
After a successful trial defined as reaching adequate pain relief upon stimulation , a fully implantable device will be placed in a second session some 2—3 weeks later on as earlier suggested. Basic design and follow-up schedule. Use and adjustment of pain medication is allowed and monitored. There are no restrictions to dosage and sort of pain medication including opioids. However, interventional pain techniques are not allowed during this time period.
If pulsed radiofrequency, epidural or peripheral injection or infusion therapy with analgesic agents or any other form of neurostimulation traditional SCS, Deep Brain Stimulation, TENS are performed, these treatments are considered as a protocol violation. They will then receive treatment and follow-up as previously described. Patients of both groups will undergo a follow-up visit after 2 weeks, 1 month, 3 months, 6 months and 12 months postrandomisation.
Standardized questionnaires investigating quality of life, physical impairment, health resources utilization, subject satisfaction and adverse events will be completed. Measures of average, worst and least pain during the previous 24 h are obtained using this diary.
Primary analysis is conducted on average pain intensity scores. Physical examination will be performed in order to assess changes in neuropathic pain symptoms. However, reduction in pain intensity is not the only clinically relevant outcome in chronic pain patients. Changes in disability, pain interference, neuropathic pain symptoms, sleeping disorders and health resources utilization are also investigated using validated questionnaires at baseline and each follow-up visit.
The red star marks the cross-over option for the CMM group. Sample size estimation was conducted using Stata software version There are no specific data to judge the effect size of CMM or the drop out rates in this specific study population. A risk difference is obtained using generalized linear modeling with a binomial distribution and an identity link.
Difference between groups in the change in pain score 6-months minus baseline , adjusted for any chance imbalance between groups at baseline ANCOVA model are also calculated. A very recent consensus protocol does not address this group [ 6 ]. Firstly, a placebo controlled setting is inappropriate as it is clearly noticeable for patients if a sham device is implanted because of the absence of paresthesia.
Secondly, ethics direct that the control group is not to be denied access to the therapy for which a cross-over is offered. Thirdly, a control group is heterogeneous because of the often individually tailored treatments for these therapy-resistant patients. This heterogeneity however mirrors daily clinical practice, and therefore generalization of the forthcoming results will be realistic.
Moreover, possible confounding variables are controlled with randomization. It must be appreciated that the validation of various outcomes is of utmost importance in pain treatment studies. We will address these components as well as other secondary outcomes as all of these issues are indispensable for a thorough efficacy analysis of any type of novel pain treatment. Per Jan, sponsorship of the study has been transferred from St.
The original protocol did not describe regulations for interim analysis, but the authors will adhere to Bayesian approach as described in Li and Gates, [ 20 ]. The authors would like to thank D. Mugan and C. Wensing, former senior clinical representatives of Spinal Modulation Inc.
Furthermore the authors would like to mention all research teams of the 8 other implanting centers for their critical review of the study protocol, in particular X. Zuidema, M. Wille, M. Kallewaard M. Elzinga, M. Van den Minkelis, M. Nijhuis, M. Antonius Ziekenhuis, Nieuwegein, The Netherlands and prof. Huygen, M. Spinal Modudaltion Inc. All three authors equally contributed to the form and content of this study protocol.
FM wrote the manuscript and is currently collecting and analyzing data of enrolled subjects. All authors read and approved the final manuscript. The first patient was enrolled in March All three authors have received funding from Spinal Modulation Inc. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Frederique M. J Spinal Disord. Anandkumar S. The effect of sustained natural apophyseal glide SNAG combined with neurodynamics in the management of a patient with cervical radiculopathy: a case report.
Physiother Theory Pract. Epub Oct Effect of Mulligan spinal mobilization with arm movement along with neurodynamics and manual traction in cervical radiculopathy patients: A randomized controlled trial. J Pak Med Assoc. National Library of Medicine U.
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