Use of Observational Mechanical Gateway
Connector in Spinal Cord Stimulation Trials

Kim, Chong H.; Issa, Mohammed; Vaglienti, Richard M

doi:10.36076/ppj.2011/14/525

Cited by 4 publications

(1 citation statement)

References 28 publications

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“…However, a recent publication based on registry data noted that 35% practitioners still use antibiotics >24 hours 110. Recent developments in the field allow different types of stimulation, and the ability to check for responses to different waveforms/technologies during the trial phase 111. If a patient demonstrates an indeterminate response with one type of waveform, adapting the inserted leads to use a different type of stimulation or a different technology without the need for another trial procedure is considered in clinical practice 112.…”

Section: Committee Statements and Recommendationsmentioning

confidence: 99%

Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain

Shanthanna

Eldabe

Provenzano³

et al. 2023

Reg Anesth Pain Med

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Spinal cord stimulation (SCS) has demonstrated effectiveness for neuropathic pain. Unfortunately, some patients report inadequate long-term pain relief. Patient selection is emphasized for this therapy; however, the prognostic capabilities and deployment strategies of existing selection techniques, including an SCS trial, have been questioned. After approval by the Board of Directors of the American Society of Regional Anesthesia and Pain Medicine, a steering committee was formed to develop evidence-based guidelines for patient selection and the role of an SCS trial. Representatives of professional organizations with clinical expertize were invited to participate as committee members. A comprehensive literature review was carried out by the steering committee, and the results organized into narrative reports, which were circulated to all the committee members. Individual statements and recommendations within each of seven sections were formulated by the steering committee and circulated to members for voting. We used a modified Delphi method wherein drafts were circulated to each member in a blinded fashion for voting. Comments were incorporated in the subsequent revisions, which were recirculated for voting to achieve consensus. Seven sections with a total of 39 recommendations were approved with 100% consensus from all the members. Sections included definitions and terminology of SCS trial; benefits of SCS trial; screening for psychosocial characteristics; patient perceptions on SCS therapy and the use of trial; other patient predictors of SCS therapy; conduct of SCS trials; and evaluation of SCS trials including minimum criteria for success. Recommendations included that SCS trial should be performed before a definitive SCS implant except in anginal pain (grade B). All patients must be screened with an objective validated instrument for psychosocial factors, and this must include depression (grade B). Despite some limitations, a trial helps patient selection and provides patients with an opportunity to experience the therapy. These recommendations are expected to guide practicing physicians and other stakeholders and should not be mistaken as practice standards. Physicians should continue to make their best judgment based on individual patient considerations and preferences.

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Section: Committee Statements and Recommendationsmentioning

confidence: 99%

Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain

Shanthanna

Eldabe

Provenzano³

et al. 2023

Reg Anesth Pain Med

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An Update of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain. Part I: Introduction and General Considerations

Manchikanti

2013

Pain Phys

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In 2011, the Institute of Medicine (IOM) re-engineered its definition of clinical guidelines as follows: “clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefit and harms of alternative care options.” This new definition departs from a 2-decade old definition from a 1990 IOM report that defined guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.” The revised definition clearly distinguishes between the term “clinical practice guideline” and other forms of clinical guidance derived from widely disparate development processes, such as consensus statements, expert advice, and appropriate use criteria. The IOM committee acknowledged that for many clinical domains, high quality evidence was lacking or even nonexistent. Even though the guidelines are important decisionmaking tools, along with expert clinical judgment and patient preference, their value and impact remains variable due to numerous factors. Some of the many factors that impede the development of clinical practice guidelines include bias due to a variety of conflicts of interest, inappropriate and poor methodological quality, poor writing and ambiguous presentation, projecting a view that these are not applicable to individual patients or too restrictive with elimination of clinician autonomy, and overzealous and inappropriate recommendations, either positive, negative, or non-committal. Consequently, a knowledgeable, multidisciplinary panel of experts must develop guidelines based on a systematic review of the existing evidence, as recently recommended by the IOM. Chronic pain is a complex and multifactorial phenomenon associated with significant economic, social, and health outcomes. Interventional pain management is an emerging specialty facing a disproportionate number of challenges compared to established medical specialties, including the inappropriate utilization of ineffective and unsafe techniques. In 2000, the American Society of Interventional Pain Physicians (ASIPP) created treatment guidelines to help practitioners. There have been 5 subsequent updates. These guidelines address the issues of systematic evaluation and ongoing care of chronic or persistent pain, and provide information about the scientific basis of recommended procedures. These guidelines are expected to increase patient compliance; dispel misconceptions among providers and patients, manage patient expectations reasonably; and form the basis of a therapeutic partnership between the patient, the provider, and payers. Key words: Evidence-based medicine (EBM), comparative effectiveness research (CER), clinical practice guidelines, systematic reviews, meta-analysis, interventional pain management, evidence synthesis, methodological quality assessment, clinical relevance, recommendations.

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An Update of the Systematic Assessment of Mechanical Lumbar Disc Decompression with Nucleoplasty

Manchikanti

2013

Pain Phys

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Background: Lumbar disc prolapse, protrusion, and extrusion account for less than 5% of all low back problems, but are the most common causes of nerve root pain and surgical interventions. The primary rationale for any form of surgery for disc prolapse is to relieve nerve root irritation or compression due to herniated disc material. The primary modality of treatment continues to be either open or microdiscectomy, although several alternative techniques are also utilized, including nucleoplasty, automated percutaneous discectomy and laser discectomy. There is a paucity of evidence for all decompression techniques, specifically alternative techniques including nucleoplasty. Study Design: A systematic review of the literature of mechanical lumbar disc decompression with nucleoplasty. Objective: To determine the effectiveness and update the effectiveness of mechanical lumbar disc decompression with nucleoplasty. Methods: The available literature on mechanical lumbar disc decompression with nucleoplasty was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Pain relief and functional improvement were the primary outcome measures. Other outcome measures were improvement of psychological status, reduction in opioid intake, and return to work. Short-term effectiveness was defined as one year or less, whereas long-term effectiveness was defined as greater than one year. Results: For this systematic review, 37 studies were considered for inclusion. Of these, there was one randomized trial and 14 observational studies meeting inclusion criteria for methodological quality assessment. Based on USPSTF criteria, the level of evidence for nucleoplasty is limited to fair in managing radicular pain due to contained disc herniation. Limitations: A paucity of literature with randomized trials. Conclusion: This systematic review illustrates limited to fair evidence for nucleoplasty in managing radicular pain due to contained disc herniation. Key words: Intervertebral disc disease, chronic low back pain, disc herniation, disc protrusion, radiculitis, contained disc herniation, mechanical disc decompression, nucleoplasty, Coblation technology, nucleotomy

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Use of Observational Mechanical Gateway Connector in Spinal Cord Stimulation Trials

Cited by 4 publications

References 28 publications

Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain

Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain

An Update of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain. Part I: Introduction and General Considerations

An Update of the Systematic Assessment of Mechanical Lumbar Disc Decompression with Nucleoplasty

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