Tag Archives: back pain

Tanezumab for Chronic Low Back Pain Relief: Phase 3 study

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“Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.” Link

“Tanezumab 2.5 mg administered subcutaneously (SC), which is being evaluated for patients with chronic pain due to moderate-to-severe osteoarthritis (OA) who have experienced inadequate pain relief with other analgesics.” Link

Comments from Pfizer regarding the study of Tanezumab for chronic low back pain, July 21 2020.

“Pfizer and Lilly made the decision to prioritize tanezumab as a potential treatment for osteoarthritis, based on an assessment of the totality of SC tanezumab data and an initial discussion with the FDA.

At this time, regulatory submissions are not planned for tanezumab in patients with moderate-to-severe chronic low back pain (CLBP), but we recognize the significant patient needs and intend to maintain an open dialogue with regulatory authorities on potential future regulatory pathways for tanezumab. Additional data analyses, and potentially further clinical study, may be required to more fully characterize tanezumab in CLBP patients.“

Additional information:

Alliance announced in early March that the U.S. FDA accepted the regulatory submission for Tanezumab, a potential first-in-class treatment for patients with chronic pain due to moderate-to-severe osteoarthritis.

Citation:

Markman, John D.a,*; Bolash, Robert B.b; McAlindon, Timothy E.c; Kivitz, Alan J.d; Pombo-Suarez, Manuele; Ohtori, Seijif; Roemer, Frank W.g,h; Li, David J.i; Viktrup, Larsj; Bramson, Candacek; West, Christine R.k; Verburg, Kenneth M.k Tanezumab for chronic low back pain, PAIN: June 25, 2020 – Volume Articles in Press – Issue – doi: 10.1097/j.pain.0000000000001928

Which Back Pain Patients Get Pain Relief from Yoga?

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PainRelief.com Interview with:
Eric J. Roseen, DC, MSc
Department of Family Medicine
Boston University School of Medicine
Department of Rehabilitation Science
Massachusetts General Hospital Institute of Health Professions
Boston, MA 02215

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: The Back to Health Study is a noninferiority randomized controlled trial of yoga, physical therapy, and back pain education for chronic low back pain. Participants were recruited from a SafetyNet hospital (Boston Medical Center) and seven affiliated federally-qualified community health centers. Participants reflected the population served by this health system, they were predominately low-income and non-white.

The yoga intervention consisted of 12 group-based, weekly, 75-minute, hatha yoga classes incorporating poses, relaxation and meditation exercises, yoga breathing and yoga philosophy. Thirty minutes of daily home practice was encouraged and supported with at-home yoga supplies. The physical therapy intervention consisted of 15 one-on-one 60-minute appointments over 12 weeks. During each appointment, the physical therapist utilized the Treatment-Based Classification Method and supervised aerobic exercise, while providing written instructions and supplies to continue exercises at home. The self-care intervention consisted of reading from a copy of The Back Pain Handbook, a comprehensive resource describing evidence-based self-management strategies for chronic lower back pain including stretching, strengthening, and the role of psychological and social factors. Participants received check-in calls regarding the reading every three weeks.

The main findings from the trial published in Annals of Internal Medicine found that yoga was non-inferior to physical therapy in terms of pain and function outcomes.

In this study published in Pain Medicine, we wanted to dig deeper and understand the characteristics of patients who tended to do better no matter what treatment they received (i.e., predictors) and characteristics that modified the likelihood that they would improve with a particular treatment (i.e., treatment effect modifiers). This type of information is useful to patients and clinicians who are trying to decide which type of treatment may be best for a unique individual experiencing back pain.

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Back Pain: Web-Based Self-help Intervention to Prevent Depression

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PainRelief.com Interview with:

Lasse B. Sander, PhD
Institute of Psychology
Department of Rehabilitation Psychology and Psychotherapy
Albert-Ludwigs-University of Freiburg
Freiburg, Germany

Lasse B. Sander, PhD Institute of Psychology Department of Rehabilitation Psychology and Psychotherapy Albert-Ludwigs-University of Freiburg Freiburg, Germany
Dr. Sander

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: People with chronic pain have a significantly increased risk of developing depression. When depression and pain collide, this is a considerable burden for those affected. In addition, pain management is made more difficult due to comorbidity.

We have known for some years now that the onset of depression can be delayed or even completely prevented by means of early psychological therapies. However, until now there has been no scalable application option available for routine healthcare.

In our study we were able to show that this can be achieved by a digital self-help intervention.

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Trial of Desipramine, Cognitive Behavioral Therapy, and Placebo for Low Back Pain Relief

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PainRelief.com Interview with:
Thomas Rutledge, PhD, ABPP
Staff Psychologist, VA San Diego Healthcare System
Professor of Psychiatry
UC San Diego

PainRelief.com:  What is the background for this study?

Response: The goal of this study was to combine our team’s pharmacy, psychiatry, and psychology expertise with chronic pain to conduct a rigorous, head-to-head efficacy trial. The clinical trial literature for chronic back pain is enormous. On the surface, this literature suggests that many medication and pain psychology treatments are effective by standards of statistical significance. These findings are difficult to interpret, however, because there are few trials comparing statistically effective chronic back pain treatments with active control treatments and nearly no trials randomizing patients with chronic back pain to medication versus pain psychology treatments. We hoped that our trial could offer data to help fill these gaps. Mindful of the increasing concerns about long-term opioid use for chronic pain, we also believed the study could have value by focusing on non-opioid agents (Desipramine) and cognitive behavioral therapy.

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Surgery vs Conservative Care Pain Relief from for Persistent Sciatica

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PainRelief.com Interview with:

Dr. Chris Bailey
Western Bone and Joint Institute

PainRelief.com:  What is the background for this study? 

Response: Acute and subacute sciatica from a lumbar disc herniation is recognized to have a very good natural history with approximately 90% making significant improvement within 4 months of onset.  Hence, studies have shown that surgery for disc herniation has a short-term benefit over non-operative care. 

In many cases, the patients not receiving surgery will improve to the level of those receiving surgery by 6 months (Peul et al, 2007).  Chronic sciatica we felt was a different situation.  

What are the main findings?

Response: Our study confirmed that surgery has a greater advantage for these patients out to 1 year following surgery.  An unpublished stat from our work found that there is a 70% greater chance of significant improvement in sciatica with surgery compared to non-operative care (including physiotherapy, education, medications, and epidural injections).  We recommend that a referral is made to a surgeon for these patients as the likelihood of improvement without surgery is much less than for acute sciatic.

PainRelief.com: What should readers take away from your report?

Response:  Previous studies have also had a difficult time controlling for cross-over and maintaining distinct treatment cohorts.  Our study was designed in such a way to utilized the inherent wait times for consultation in our Canadian health care system so to prevent crossover from the non-op group to the surgical group.

PainRelief.com: What recommendations do you have for future research as a result of this work?

Response: Our plan is to perform future cost effectiveness analysis and publish on long term outcomes as well.

Citation:

Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months
Chris S. Bailey, M.D., Parham Rasoulinejad, M.D., David Taylor, M.D., Keith Sequeira, M.D., Thomas Miller, M.D., Jim Watson, M.D., Richard Rosedale, P.T., Stewart I. Bailey, M.D., Kevin R. Gurr, M.D., Fawaz Siddiqi, M.D., Andrew Glennie, M.D., and Jennifer C. Urquhart, Ph.D
Nengl j med 382;12 nejm.org March 19, 2020

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Chiropractic Care Linked to Lower Use of Opioids for Spinal Pain Relief

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PainRelief.com Interview with:
Jim Whedon DC, MS
Director of Health Services Research
SCU Health System
Southern California University of Health Sciences
Whittier, CA 

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: Utilization of nonpharmacological pain management may prevent unnecessary use of opioids.

Our objective was to evaluate the impact of chiropractic utilization upon use of prescription opioids among patients with spinal pain. Overall, in the states of CT, MA and NH, at any particular time in the study period of 2012-2017, between 1.55 and 2.03 times more nonrecipients of chiropractic care.filled an opioid prescription, as compared with recipients.

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Low Back Pain: AI Can Expedite Pain Relief Recommendations Through Electronic Record

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PainRelief.com Interview with:

Ismail Nabeel MD, MPH
Associate Professor
Public Health and General Preventive Medicine
Mount Sinai Medical Center

Dr. Nabeel

PainRelief.com:  What is the background for this study?

Response: Acute and chronic low back pain (LBP) are different conditions with different treatments. However, they are coded in electronic health records with the same International Classification of Diseases, 10th revision (ICD-10) code (M54.5) and can be differentiated only by retrospective chart reviews. This prevents an efficient definition of data-driven guidelines for billing and therapy recommendations, such as return-to-work options, etc.

In this feasibility study, we evaluated if Artificial intelligence can automatically distinguish the quality of Low Back Pain (LBP) episodes by analyzing free-text clinical notes from the treating providers. 

These clinical notes were collected during a previous pilot study evaluating an RTW tool based on EHR data that included nearly 40,000 encounters for 15,715 patients spanning from 2016 to 2018 and clinical notes written by 81 different providers. We used a dataset of 17,409 clinical notes from different primary care practices; of these, 891 documents were manually annotated as “acute low back pain” and 2,973 were generally associated with LBP via the recorded ICD-10 code. 

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Safety And Efficacy Of The Unique Opioid Buprenorphine For Chronic Pain Relief

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PainRelief.com Interview with:
Joseph V. Pergolizzi, Jr., M.D.
Co-Founder and Chief Operating OfficerNEMA Research Inc.

Joseph V. Pergolizzi, Jr., M.D. Co-Founder and Chief Operating OfficerNEMA Research Inc.

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: Chronic low back pain (CLBP) is a leading cause of disability.

  • Acetaminophen and nonsteroidal anti-inflammatory drugs are first-line analgesic options or mild CLBP; however, when certain patients with moderate to severe CLBP do not achieve adequate pain relief, opioids are considered as an add-on therapy. Unfortunately, most opioid analgesics have the potential for adverse effects, abuse, and diversion.
  • Buprenorphine buccal film (Belbuca®) is an opioid analgesic classified as a Schedule III controlled substance in the United States and is a partial μ-opioid receptor agonist.
  • Buprenorphine buccal film is a unique analgesic that is approved by the US Food and Drug Administration for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment for whom alternative treatment options are inadequate.
  • Two pivotal phase 3 clinical trials (Study 307, Clinical Trial ID NCT01675167, and Study 308, Clinical Trial ID NCT01633944) established the efficacy and safety profiles of buprenorphine buccal film.
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Back Pain in Elderly: Most Patients Do Not Receive Physical Therapy

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PainRelief.com Interview with:
Dan Ly MD MPP
Staff Physician, VA Boston Healthcare System
Ph.D. Candidate in Health Policy (Economics)
Harvard University

Dan Ly Ph.D. Candidate in Health Policy (Economics) Harvard University

PainRelief.com:  What is the background for this study?

Response: New low back pain is a common complaint in primary care clinics. Prior research examining care patterns up to 2010 and sampling individual visits has found increasing use of opioids and advanced imaging and decreasing use of NSAIDs during this time period.

However, because care is delivered longitudinally, this study examined the care delivered to patients for new low back pain over the course of the year, which allowed me to look at the timing and sequence of care.

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Acute Low Back Pain: Does Ibuprofen With or Without Acetaminophen offer Pain Relief?

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PainRelief.com Interview with:
Benjamin W. Friedman, MD, MS
Department of Emergency Medicine
Montefiore Medical Center, Albert Einstein College of Medicine
Bronx, NY, 10467

Benjamin W. Friedman, MD, MS Department of Emergency Medicine Montefiore Medical Center, Albert Einstein College of Medicine Bronx, NY, 10467

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: Low back pain is a highly prevalent problem that causes more than 2 million visits to American emergency departments annually. Nonsteroidal anti-inflammatory drugs are first line medical management of this ailment, but are only modestly effective. We conducted an RCT to determine if adding acetaminophen to nonsteroidal anti-inflammatory drugs could improve outcomes two days and seven days after an ED visit for low back pain. Unfortunately, acetaminophen did not improve this outcomes.

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