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January 9, 2019

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CHOIR Results Demonstrate Shortest Path Between Primary Care and Pain Medicine for the Most Complex Patients

Feb. 18, 2016, PALM SPRINGS, Calif. –- The care of complex patients with pain exhibits a closer connection between primary care and the specialty of pain medicine than that seen with less complex patients, Stanford researchers reported today. Results presented in a scientific poster at the 32nd Annual Meeting of the American Academy of Pain Medicine described the construction of a network algorithm to better characterize the relationship between primary care and pain medicine.

“We attempted to measure patient complexity by the number of specialty clinics each patient goes to and by their psychological distress,” said lead author Ming-Chih Kao, MD, PhD, a clinical assistant professor within the Stanford University School of Medicine in Palo Alto, Calif. “We found that the nature of care coordination is structurally different for complex patients. For complex patients who also have chronic pain, the coordination between primary care and pain medicine is particularly essential to the overall delivery of care.” 
The research team previously reported results that found the main driver of patient experience depends less on the individual provider than on the overall coordination among the clinic, the primary care physician and all others who participate in delivery of care. Building on that work, the researchers further studied the nature and role of care coordination for the pain medicine specialty, focusing on the organizational aspects and the multi-faceted nature of healthcare delivery for patients with many needs. 
In data analyzed from the Collaborative Health Outcome Information Registry (CHOIR), a total of 11,941 patients with chronic pain were seen across 160 clinics in 38 specialties and primary care. Each specialty represented a vertex on the network. Graph theory-based statistical methods were used to measure the collaborative relationships among specialties in this network.
The researchers discovered that the shortest path of three included dermatology and orthopedics (mean 3.47 +/- SD 0.54). Interestingly, though, for the 1,806 patients who visited at least six specialties, pain medicine and primary care were consistently strongly connected with shortest path distance of one (p<0.001). The finding was persistent for patients with more complexity.

“In our observation, pain medicine is at once closest to primary care and farthest from it,” Dr. Kao said, explaining that for the common pain complaints seen in primary care — back pain, neck pain and headache — pain medicine specialists typically get referrals only after several other specialties have been tried and failed.
The CHOIR platform is a learning health system created at Stanford in partnership and with funding through the National Institutes of Health. As a platform for learning health systems, CHOIR captures not only patient-reported outcomes but also clinical data in the electronic medical record system. More information on the CHOIR platform is at choir.stanford.edu.
“This work highlighted the power of combining clinical data with patient-reported outcomes,” Dr. Kao said.

Poster 175 – Network of Coordinated Care: Collaborative Relationship of Pain Medicine with Primary Care for Complex Patients with Pain: A Large-Scale Network Study Using a Learning Health System Platform

Intradiscal Biacuplasty Sustains Long-term Superiority Over Conservative Treatment for Discogenic Low-Back Pain

Feb. 18, 2016, PALM SPRINGS, Calif. – Patients treated with intradiscal biacuplasty (IDB) for discogenic back pain maintained benefits a year later, and those who crossed over to IDB treatment mid-study reported similar gains, study investigators reported. The results were presented today in a scientific poster at the 32nd Annual Meeting of the American Academy of Pain Medicine.

Contrary to the majority of chronic pain interventions, the minimally-invasive IDB demonstrated long-term benefit with no procedure-related complications, said Michael Gofeld, MD, the principal investigator and senior author. 
“The results were not only statistically significant, but — more importantly — clinically meaningful,” said Dr. Gofeld, a practicing chronic pain management specialist and anesthesiologist at St. Michael’s Hospital and Women’s College Hospital in Toronto, Canada, and an associate professor of Medicine at the University of Toronto. “Without addressing disc pathology, pain and function do not get better.”
Every year, up to one in five Americans suffers from low-back pain (LBP), and discogenic pain due to degeneration of the intervertebral discs is a chief cause (Zhang et al Int J Biol Sci 2009;5:647–58). Sufferers are often forced to choose between conservative treatment, which includes medications such as nonsteroidal anti-inflammatory drugs and physical therapy, or more invasive fusion surgery, often with limited success or the risk of complications.
This study followed 22 patients from the original IDB and comprehensive medical management (IDB+CMM) group of a prospective, randomized, multi-center, open-label trial for an additional six months. In the original trial, the combination of IDB+CMM overwhelmingly exceeded CMM alone at six months on measures of pain, function, quality of life and global impression of change. The investigators found that statistically and clinically significant improvements over baseline were sustained at 12 months on all measures, with pain reduction of more than 2 points on the visual analog scale and a decrease of 14 points on the Oswestry Disability Index. The quality of life index also improved.
In addition, the 25 patients who elected to cross over from CMM to the active treatment group responded similarly in terms of pain reduction and improved functional status. Importantly, without IDB, patients in the CMM group did not show improvement, Dr. Gofeld said.

The equipment to perform IDB, a technique that uses cooled radiofrequency to destroy culprit nociceptive nerves in degenerative spinal discs, was first developed by Baylis Medical Company in Canada and was approved by the U.S. Food and Drug Administration in 2007. Dr. Gofeld, who performed the first procedures in Canada, explained that patients who benefit have the following features:

  • LBP without sciatica
  • Disc degeneration that is limited to 1-2 levels
  • Preservation of at least 50 percent of disc height
  • No significant herniation
Now that clinical benefits have been established through this and previous research (Kapural et al Pain Med 2013;14:362-73, Kapural et al Pain Med 2015;16:425-31, Desai et al Spine 2015 [Epub ahead of print]), barriers to insurance coverage must be addressed, Dr. Gofeld said. “Once both efficacy and effectiveness are established in such a rigorous research setting, the procedure should be approved by payers. It has no CPT (Current Procedure Terminology) code, and the access for patients remains difficult.”

Poster 123 – Long-Term Results (12-Months) of a Prospective, Multicenter, Open-Label Clinical Trial Comparing Intradiscal Biacuplasty to Conventional Medical Management for Discogenic Lumbar Back Pain

Funding: Kimberly Clark Corporation 

More Evidence of the Power of Mesenchymal Stem Cell Transplant to Block Opioid-Induced Hyperalgesia and Tolerance

Feb. 18, 2016, PALM SPRINGS, Calif. – Cleveland Clinic researchers have found new evidence that modulating neuroinflammation with stem cell transplants may prove to be an effective strategy to treat both opioid tolerance (OT) and opioid-induced hyperalgesia (OIH). The latest results in this line of inquiry, which may have the potential to transform opioid therapy for pain, are on view today at the 32nd Annual Meeting of the American Academy of Pain Medicine.

The investigators found that the development of OT and OIH was effectively prevented in rats by either intravenous (IV) or intrathecal mesenchymal stem cell (MSCs), which were transplanted before morphine treatment. Furthermore, established OT and OIH were significantly reversed when the timing of the transplants followed repeated morphine injections.

“We have demonstrated that MSC transplantation promises to be a potentially safe and effective way to prevent and reverse two of the major problems associated with opioid therapy,” said Jianguo Cheng, MD, PhD, professor of  anesthesiology and director of the Cleveland Clinic Pain Medicine Fellowship Program.

“This emerging therapy has enormous potential to profoundly impact clinical practice. It may improve the efficacy of opioid therapy, reduce the risk of opioid overdose and save lives,” he said. 

Neuroinflammation that involves activation of microglia and astrocytes in the central nervous system contributes greatly to OT and OIH. Both OT, in which higher doses become necessary, and OIH, a heightened pain response, can limit effectiveness and compromise safety during opioid therapy to treat pain. The anti-inflammatory and immune modulatory properties of MSCs have been previously demonstrated. Last year, the same scientific research team reported that intrathecal MSC transplant reduced OIH and OT in rats. For the current study, the investigators further tested the anti-tolerance and anti-hyperalgesia effects of MSC, this time by IV application and in mice as well as rats.

The IV transplant was given seven days before or 14 days after the initiation of daily morphine injections to test both the preventive and therapeutic effects of MSCs. Investigators evaluated OT and OIH by foot withdrawal thresholds in response to mechanical or thermal stimulation. They also examined multiple safety parameters, including normal locomotion, body weight gain, liver and kidney function, and vital organ pathology exams.

Using immunohistochemistry, they found that the treatments significantly reduced the activity of microglia and astrocytes in the spinal cord. The analysis of safety measures revealed no abnormalities in the animals’ vital organs or functions. The investigators are planning a preclinical investigation in preparation for clinical trials.

Poster 233 – Intravenous Transplantation of Bone Marrow–Derived Mesenchymal Stem Cells Attenuated Activation of Glial Cells and Reversed Opioid Tolerance and Opioid-Induced HyperalgesiaFunding: US Department of Defense Grant and Cleveland Clinic Anesthesiology Institute Research Fund

Sphenopalatine Ganglion Block is Found Fast, Effective and Safe for Postdural Puncture Headache in Obstetric Patients

Feb. 18, 2016, PALM SPRINGS, Calif. – New research suggests that sphenopalatine ganglion block (SPGB) relieves disabling headache from dural puncture faster than the usual care of epidural blood patch (EBP) and lacks the potential for rare but profound complications that can accompany EBP. A non-invasive treatment with minimal side effects, SPGB is a highly effective treatment for accidental postdural puncture headache (PDPH) in obstetric patients, according to results from a retrospective analysis on view today in a scientific poster at the 32nd Annual Meeting of the American Academy of Pain Medicine.

At 24-48 hours, both treatments were similarly effective; however, SPGB was associated with greater headache relief at 30- and 60- minutes post-treatment, said lead author Preet Patel, MD, a research fellow at Rutgers – Robert Wood Johnson (RWJ) Medical School in New Brunswick, N.J. He said advantages of SPGB include its relative ease of administration and lower complication rates.

“One of the advantages of SPGB is that you will know relatively quickly if it is providing headache relief for your patient,” Dr. Patel said. “If the block is not effective within the first three hours, you can switch to the more invasive EBP.” And if it does work, he said, the new mothers can avoid the complications that can appear days or weeks later with EBP and enjoy a quicker recovery, “which is absolutely critical in this population.”

Disabling headache from dural puncture can follow the administration of spinal anesthesia. According to the International Headache Society, PDPH worsens with sitting upright, improves with reclining and is accompanied by neck stiffness, tinnitus, photophobia or nausea. When conservative measures such as oral medications or caffeine fail to relieve the often-severe headache pain, EBP is the usual treatment choice. Unfortunately, EBP can lead to significant complications on rare occasions, including motor and sensory deficits, meningitis, hearing loss,

Horner’s Syndrome and subdural hematoma (Snidvongs & Shah JRSM Short Reports 2012;3:68, Beilin & Spitzer A A Case Rep 2015;4:163-5, Kardash et al Reg Anesth Pain Med 2002;27:433-6). 

Dr. Patel described the history of SPGB use for headache relief, including migraine and cluster headache, going back for over 100 years but said it had not been previously adequately studied for PDPH treatment.

The investigators reviewed 72 records over 17 years of women without a previous history of primary headaches who had experienced PDPH during childbirth. Thirty-three women received SPGB (with EBP available upon request), and 39 women received routine EBP. The women were similar in age, height, BMI and potential risk for suffering complications from general anesthesia.

The superior pain relief with SPGB was observed at the earliest time points: 55 percent of those receiving SPGB had recovered from headache at one-half hour post-treatment compared with 21 percent in the EBP treatment group. At one hour post-treatment, 64 percent of SPGB recipients had recovered vs. 31 percent in the EBP treatment group. At 24 hours, 48 hours and one week post-treatment, no differences were seen in pain relief. However, EBP recipients experienced higher complication rates, including nine patient emergency-room visits, three complaints of backache radiating to the leg, one vasovagal reaction and one complaint of temporary hearing loss.

Dr. Patel said that although the study is small and retrospective, the results are ample evidence to ask anesthesiologists to consider using the non-invasive SPGB for the treatment of PDPH in obstetric patients before they consider using the more invasive EBP. The research team in the Department of Anesthesiology at Rutgers – RWJ is planning a prospective study and hopes to report data within three years.
Poster 145 – Sphenopalatine Ganglion Block (SPGB) Versus Epidural Blood Patch (EBP) for Accidental Postdural Puncture Headache (PDPH) in Obstetric Patients: A Retrospective Observation

Stanford Researchers Tout Successful CHOIR Rollout as Example of Private-Public Partnership That Works

Feb. 18, 2016, PALM SPRINGS, Calif. –- In an example of a successful private-public partnership, the creators of a technologically advanced national registry to collect data on the experience of pain sufferers and their responses to treatment are reporting significant growth across the globe. The results are on view today in a scientific poster at the 32nd Annual Meeting of the American Academy of Pain Medicine (AAPM).

The Stanford-developed and implemented Collaborative Health Outcomes Information Registry (CHOIR) is an open-source web application, created to assess patients and simultaneously to support clinic staff by integrating the pain registry into the clinic workflow. A key component of CHOIR is the National Institutes of Health (NIH)-funded PROMIS system. PROMIS stands for Patient Reported Outcome Measurement Information System, a system of item banks that capture a wide range of physical, psychological and social functioning domains. The ultimate aim is data-based and coordinated care that is available just-in-time to the clinician and that is centered on the patient.

Since the program’s rollout in August 2012, more than 7,500 unique patients have completed surveys, via email or in clinic using iPads, the study authors reported. Furthermore, more than 210,000 NIH PROMIS assessments were captured, including items addressing global health, mood, function, sleep and social functioning. The study’s lead author said that the data collected by CHOIR are particularly powerful in aggregate.

“We have demonstrated the feasibility of using CHOIR to assess specific patient-reported outcome measures while the survey is being completed,” said Ming-Chih Kao, M.D., Ph.D., clinical assistant professor within the Stanford University School of Medicine in Palo Alto, Calif. “This, in particular, has enabled targeted measurement of relevant subsets of patients so that the results are highly relevant and the patient burden remains minimal.”

Furthermore, he added, “In CHOIR we found that large-scale patient-reported outcome capture has revealed patterns and signals that would otherwise be hidden.” 

Dr. Kao described the growth of CHOIR sites to include new pain medicine clinics, non-pain specialties and expansion into Canada, Australia and Israel. In addition, “as pain medicine specialists, we have also worked with the AAPM to expand the platform to the perioperative setting, including preoperative clinic and acute pain settings,” he said.

The need to improve patient outcome registries is one of the goals set by the Institute of Medicine (IOM) in its 2011 report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. The IOM report documented more than 100 million Americans who suffer chronic pain at costs in medical expenses and lost productivity that reach up to $635 billion a year. Dr. Kao praised the power of the CHOIR open platform in which participants may contribute to and benefit from the sharing of programs, algorithms and data. “Over the past year, our experience in engaging stakeholders at institutions across different nations revealed common unmet needs in 21st century healthcare delivery and research,” he said. “Remarkably, these common needs cut across differences between patient populations, between cultures and between healthcare systems.”

Dr. Kao said the NIH partnership from inception, implementation and, now, dissemination is a key strength of CHOIR. “Our foundational partnership with NIH reaffirms the open nature of the CHOIR platform and its availability to participants across the globe.” 
More information on the CHOIR platform is at http://choir.stanford.edu

Poster 177 –Collaborative Health Outcomes Information Registry (CHOIR): Open Source Platform for Learning Health Systems
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AAPM

American Academy of Pain Medicine