The Polyanalgesic Consensus Conference (PACC)®: Intrathecal Drug Delivery Guidance on Safety and Therapy Optimization When Treating Chronic Noncancer Pain.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians and scientists based on expertise with international representation to establish evidence-based guidance on intrathecal drug delivery in treating chronic pain. This Polyanalgesic Consensus Conference (PACC)® project, created more than two decades ago, intends to provide evidence-based guidance for important safety and efficacy issues surrounding intrathecal drug delivery and its impact on the practice of neuromodulation. MATERIALS AND METHODS: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when PACC® last published guidelines) to the present. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence is scant. RESULTS: The PACC® examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The PACC® recommends best practices regarding intrathecal drug delivery to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate.

The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines.

INTRODUCTION: Pain treatment is best performed when a patient-centric, safety-based philosophy is used to determine an algorithmic process to guide care. Since 2007, the International Neuromodulation Society has organized a group of experts to evaluate evidence and create a Polyanalgesic Consensus Conference (PACC) to guide practice. METHODS: The current PACC update was designed to address the deficiencies and innovations emerging since the previous PACC publication of 2012. An extensive literature search identified publications between January 15, 2007 and November 22, 2015 and authors contributed additional relevant sources. After reviewing the literature, the panel convened to determine evidence levels and degrees of recommendations for intrathecal therapy. This meeting served as the basis for consensus development, which was ranked as strong, moderate or weak. Algorithms were developed for intrathecal medication choices to treat nociceptive and neuropathic pain for patients with cancer, terminal illness, and noncancer pain, with either localized or diffuse pain. RESULTS: The PACC has developed an algorithmic process for several aspects of intrathecal drug delivery to promote safe and efficacious evidence-based care. Consensus opinion, based on expertise, was used to fill gaps in evidence. Thirty-one consensus points emerged from the panel considerations. CONCLUSION: New algorithms and guidance have been established to improve care with the use of intrathecal drug delivery.

Trialing and Maintenance Dosing Using a Low-Dose Intrathecal Opioid Method for Chronic Nonmalignant Pain: A Prospective 36-Month Study.

OBJECTIVE: To evaluate low-dose intrathecal opioid trialing and maintenance with regard to analgesia and psychometric functional capacity. MATERIALS AND METHODS: Prospective cohort of subjects offered, trialed and maintained using low-dose opioid therapy via an intrathecal drug delivery system. Analgesia, measured by visual analog scale and the Global Pain Scale, and function, measured by Multidimensional Pain Inventory and Global Pain Scale, are evaluated. Population analysis by age, gender, oral opioid dose, diagnosis, and pain type is reported. RESULTS: Fifty-eight subjects enrolled in the 36-month evaluation period with mean opioid intrathecal opioid dose less than 350 µg per day of morphine equivalent utilized. Primary nociceptive pain type were associated with lower intrathecal opioid doses and improved visual analog scale pain rating and improved pain severity and interference on the Multidimensional Pain Inventory. CONCLUSIONS: This study adds to the growing body of literature suggesting that low-dose intrathecal analgesia without oral opioid supplementation can be efficacious. It appears that this approach may achieve analgesia with lower doses in those with primary nociceptive pain type.

Minimally invasive direct decompression for lumbar spinal stenosis: impact of multiple prior epidural steroid injections.

Background: A modified algorithm for the treatment of lumbar spinal stenosis with hypertrophic ligamentum flavum using minimally-invasive lumbar decompression (mild®)was assessed, with a focus on earlier intervention. Patients & methods: Records of 145 patients treated with mild after receiving 0-1 epidural steroid injections (ESIs) or 2+ ESIs were retrospectively reviewed. Pain assessments as measured by visual analog scale (VAS) scores were recorded at baseline and 1-week and 3-month follow-ups. Results: Improvements in VAS scores at follow-ups compared with baseline were significant in both groups. No statistically significant differences were found between the two groups. Conclusion: Multiple ESIs prior to mild showed no benefit. A modified algorithm to perform mild immediately upon diagnosis or after the failure of the first ESI is recommended.

Lay abstract Physicians use a structured decision-making process (an algorithm) to decide how best to treat lumbar spinal stenosis (LSS) that results from abnormal thickening of the spinal ligaments that run the length of the spinal cord. Early treatments can include one or more epidural steroid injections (ESIs). This study evaluated a change to the algorithm that involves earlier intervention with a minimally invasive, short outpatient procedure that removes a major root cause of the abnormal thickening (lumbar decompression) and leaves no implants behind. Records of patients treated with minimally-invasive lumbar decompression (mild^®) after receiving either a single ESI procedure or none at all, were compared with the records of patients who underwent the mild procedure after receiving two or more ESIs (145 total patients). The patients' pain scores before surgery, at 1 week postsurgery and at 3 months postsurgery were reviewed. The improvements in pain scores following the mild procedure were compared within each group and between the two groups. The improvements in pain scores at both the 1-week and 3-month follow-up visits indicated that the mild procedure had a positive effect for both groups. Further, there were no significant differences in how much pain scores improved when the two groups were compared. Since neither group experienced significantly more pain relief than the other, there appears to be no benefit to having multiple ESI procedures before undergoing the mild procedure. The authors recommend that the algorithm be modified to perform the mild procedure either as soon as LSS is diagnosed or after the failure of the first ESI procedure.

Understanding whether chronic lower back pain patients with lumbar spinal stenosis benefit from multiple epidural steroid injections prior to the mild® Procedure.

Originally published in Pain Management, this article is a summary of a study performed to look at the benefit, if any, of more than one epidural steroid injection in the spine before the mild® Procedure. Minimally invasive lumbar decompression (commonly known as the mild Procedure) and epidural steroid injections are both common treatment options for lumbar spinal stenosis (commonly referred to as LSS), a condition that causes chronic lower back pain in older adults. To determine how to best treat LSS patients, healthcare professionals use a guide to help with the decision-making process (called an algorithm) to pass through non-medical to more invasive therapies that often includes one or more epidural steroid injections. An epidural steroid injection is medication inserted in the lower back to reduce swelling and provide relief from pain. Researchers wanted to look at a change to when in the treatment process the mild Procedure is carried out. In the study, researchers compared the medical records of participants who had received either just one or no steroid injection prior to the mild Procedure, to participants who received two or more epidural steroid injections prior to the mild Procedure. Similar outcomes in both treatment groups in this study proved that giving more than one epidural steroid injection prior to the mild Procedure did not improve how well patients did and may have delayed patient care. Based on the results of the study, it is recommended that the standard treatment process for LSS patients be changed to give the mild Procedure either as soon as LSS is diagnosed or after the failure of the first epidural steroid injection.

A post-market, randomized, controlled, prospective study evaluating intrathecal pain medication versus conventional medical management in the non-cancer, refractory, chronic pain population (PROSPER).

INTRODUCTION: Intrathecal therapy has been limited by non-randomized prospective studies, particularly for those suffering from non-cancer. Further, no prospective, randomized studies investigating the efficacy, safety, and utilization of intrathecal polyanalgesic consensus guidelines exist. METHODS: After IRB approval, patients were enrolled in a 1:1 fashion for intrathecal drug delivery (IDD) or conventional management (CMM), employing standard of care, excluding intrathecal drug delivery, based on the principal investigator's discretion. They were followed 3, 6, 9, and 12 months. Assessments included PROMIS 29, NPRS, and PriceMonkey. RESULTS: Seventy-nine patients were screened, 54 patients were enrolled: 26 to IDD and 28 to CMM. At 3 months, there was no measurable difference in pain improvement in either subgroups within the CMM for chronic pain-related syndromes (CPRS) or failed back and related spine disorders (FBRS). For the IDD, early and maintained benefit from the baseline was statistically achieved. Cost analysis of pump to CMM breakeven was 4.5 months. There were no adverse events related to compounded intrathecal medications. CONCLUSION: This is the first randomized prospective, multicenter study investigating the safety, cost, and efficacy of off-label medications for intrathecal therapy, as compared to conventional management, and suggests early detection of improvement, cost savings, safety of intrathecal compounded medication use, and safety and efficacy of employing the PACC guidance.

Best Practices for Minimally Invasive Lumbar Spinal Stenosis Treatment 2.0 (MIST): Consensus Guidance from the American Society of Pain and Neuroscience (ASPN).

Introduction: Lumbar spinal stenosis (LSS) is a common spinal disease of aging with a growing patient population, paralleling population growth. Minimally invasive treatments are evolving, and the use of these techniques needs guidance to provide the optimal patient safety and efficacy outcomes. Methods: The American Society of Pain and Neuroscience (ASPN) identified an educational need for guidance on the prudent use of the innovative minimally invasive surgical therapies for the treatment of symptomatic LSS. The executive board nominated experts spanning anesthesiology, physiatry, orthopedic surgery, and neurosurgery based on expertise, publications, research, diversity and field of practice. Evidence was reviewed, graded using the United States Preventive Services Task Force (USPSTF) criteria for evidence and recommendation strength and grade, and expert opinion was added to make consensus points for best practice. Results: The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Scopus, and meeting abstracts to identify and compile the evidence (per section) for LSS-related pain. Search words were selected based upon the section represented. Identified peer-reviewed literature was critiqued using USPSTF criteria and consensus points are presented. Discussion: The algorithm for patient selection in the management of symptomatic spinal stenosis is evolving. Careful consideration of patient selection and anatomic architecture variance is critical for improved outcomes and patient safety. Conclusion: ASPN created a guidance for best practice for minimally invasive surgical treatment of symptomatic spinal stenosis.