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

Neck Pain Relief Utilizing Progressive Resistance Exercise

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PainRelief.com Interview with:
ROSS ILES  PhD, Dip WDP, BPhysio(Hons)
Insurance Work and Health Group
Senior Research Fellow Department of Physiotherapy
Adjunct Senior Lecturer,Health Services Division
School of Public Health and Preventive Medicine
Monash University Melbourne, VIC Australia

ROSS ILES PhD, Dip WDP, BPhysio(Hons) Insurance Work and Health Group Senior Research Fellow Department of Physiotherapy Adjunct Senior Lecturer Health Services Division School of Public Health and Preventive Medicine Monash University Melbourne, VIC Australia
Dr. ILES

PainRelief.com:  What is the background for this study

Response: Chronic neck pain is estimated to have a worldwide mean lifetime prevalence of 48.5%, and the pain and disability associated with this condition accounts for 2.5% of the total years lost to disability in Australia. Chronic neck pain is known to be associated with neck muscle weakness in all planes of movement of up to 66% when compared to participants presenting with no history of neck pain. Therefore, neck strengthening exercises are commonly utilised in the treatment of chronic neck pain, with many different programs being described within the literature. Studies investigating the effect of strengthening exercises on chronic neck pain have found a short to intermediate term improvement in pain by a moderate to large amount. However, many strengthening programs do not target the multi-directional weakness which has been shown to be prevalent in this population group.

Through a case series of patients with chronic neck pain we aimed to determine whether a neck-specific progressive resistance program targeting all planes of cervical movement led to a change in pain and disability, and to investigate the relationship between neck strength, pain, and disability.

Data analysis was performed on patients after completing nine sessions of a neck-specific progressive resistance exercise intervention utilising the Melbourne Protocol and the Multi-Cervical Unit (MCU) technology under supervision of the treating physiotherapist. Participants completed isotonic exercises against the MCU provided resistance in the planes of cervical flexion, extension, and lateral flexion, all at neutral cervical rotation and 25 degrees left and right. Neck pain and disability were assessed with the Numerical Rating Scale (NRS) and Neck Disability Index (NDI) respectively, with neck strength measured and recorded through the MCU.

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Study Finds Patients Feel Empowered By Interventions for Pain Relief

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PainRelief.com Interview with:

Johan Hambraeus, MD
Board certified in anesthesiology, family medicine & Pain management
Department of Epidemiology and Global Health
Umeå University, Sweden

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

Response: When working with interventional pain management a striking feature is that all procedures are painful. It is often discussed about sedation before procedures, but whether to provide sedation seems to be more based on the local tradition than on facts. And it is not seldom that patients describe that they have phobic fear of needles, but despite this they cope with the interventional pain management and all the painful procedures.

Therefore we wanted to understand how it is felt and how the patients describe their experiences.

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Study Evaluates Effects of Inhaled Cannabis for Pain Relief in Adults With Sickle Cell Disease

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PainRelief.com Interview with:

Donald I. Abrams, MD
Division of Hematology-Oncology
Department of Medicine,
Zuckerberg San Francisco General Hospital
University of California, San Francisco

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

Response: A number of years ago, Kalpna Gupta, PhD, an investigator then at the University of Minnesota, came and told me about her mice with Hemoglobin SS who experienced pain that responded to laboratory cannabinoids. She was going to apply for a grant from the National Heart, Lung and Blood Institute to continue her studies and sought us out because of our prior clinical trials with cannabis and pain. Dr. Gupta wanted to include a pilot proof of principle human study in her application and asked if we could design one. As cannabidiol (CBD) was just becoming known at that time, we suggested to do a study in patients with sickle cell disease and pain looking at a delta-9-tetrahydrocannabinol (THC)-dominant strain of inhaled cannabis, a CBD-dominant strain, a balanced 1:1 strain and placebo. She said that we would only have funds to do a two-arm study, one of which needed to be placebo. As we had already shown that there was a trend for vaporized cannabis that was predominantly THC to add to the analgesic effect of sustained-release opioids in patients with chronic pain, we chose to investigate a 4.4% THC:4.9% CBD product obtained from the National Institute on Drug Abuse.

We designed a crossover trial so that each participant would spend two 5-day inpatient stays separated by at least a month in our Clinical Research Center at Zuckerberg San Francisco General Hospital. During one stay they would add vaporized cannabis to their stable ongoing analgesic regimen and during the other stay they would inhale placebo cannabis three times a day. We use the Volcano vaporizer device that heats the plant material and not an oil as has become popular in the recent “vaping” craze. Our target was to enroll 35 patients with sickle cell disease and chronic ongoing pain on an opioid-containing regimen. Our primary endpoint was change in pain as measured by way of a visual analog scale and the Brief Pain Inventory as well as safety.

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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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Pain Relief Patch Significantly Reduced Moderate to Severe Chronic Pain

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PainRelief.com Interview with:
Peter Hurwitz
President
Clarity Science, LLC

Clarity Science Logo. (PRNewsFoto/Clarity Science)

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

Response: Over the past several years, there has been a big push from healthcare professionals and patients to identify alternative pain management treatments and multimodal approaches that have been shown to have minimal side effects for those who experience mild to moderate and chronic pain conditions. These strategies may include non-pharmacological and pharmacological therapies. Topical therapies have been shown to address various pain conditions with minimal side effects as compared to oral over-the-counter (OTC) agents, prescription NSAIDs, and prescription opioids. T

his IRB-approved study evaluated whether a topical analgesic pain-relieving patch containing methyl salicylate (10%), Menthol (6%) and Camphor (3.1%) could reduce pain severity and improve function in patients over the course of 14 days.

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Furry Social Robots May Provide Some Pain Relief

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­PainRelief.com Interview with:

­ Shelly Levy-Tzedek, PhD
Head of the Cognition, Aging and Rehabilitation Lab
Faculty of Health Sciences, Dept. of Physical Therapy 
& The Zlotowski Center for Neuroscience
& ABC Robotics Initiative
The Ben Gurion University of the Negev

Prof. Levy-Tzedek

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

Response: It is known that close, effective human touch can help alleviate pain. We set out to test whether touch interaction with a social robot can also reduce the sensation of pain. We found that it does: young, healthy people who touched the robot during the application of painful stimuli reported feeling less pain than when it was in the room with them (with no direct contact), or when it was not present at all. They also reported increased levels of happiness. 

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Which Older Adults Use Cannabis for Chronic Pain Relief?

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PainRelief.com Interview with:
Julie Bobitt, PhD
Director, Interdisciplinary Health Sciences
University of Illinois at Urbana Champaign
Champaign, IL. 61820

Dr. Julie Bobitt
Dr. Julie Bobitt

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

Response: Our previous research found that older adults, who we interviewed, used cannabis primarily for pain related reasons and that they were reporting using cannabis to reduce or altogether stop their use of opioids.  We wanted to further study this and we wanted to see if there were any differences between self-reported pain in non-cannabis users vs. cannabis users and then if there were differences between groups who used cannabis alone versus those who used opioids alone, versus cannabis in combination with opioids. 

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Opioids Frequently Prescribed For Headache Pain Relief

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PainRelief.com Interview with:
Richard B. Lipton, M.D.
Professor, The Saul R. Korey Department of Neurology
Professor, Department of Psychiatry and Behavioral Sciences
Professor, Department of Epidemiology & Population Health
Edwin S. Lowe Chair in Neurology
Vice Chair The Saul R. Korey Department of Neurology
Director, Montefiore Headache Center
Albert Einstein College of Medicine

PainRelief.com:  What is the background for this study

Response: Almost everyone with migraine takes acute treatments at the time of attacks to relieve pain and restore function.  Acute treatments include over-the-counter medications. prescription drugs and devices.  The most widely used prescription drugs for migraine are triptans (such as sumatriptan and rizatriptan) and NSAIDs (such as ibuprofen and naproxen). 

Richard B. Lipton, M.D. Professor, The Saul R. Korey Department of Neurology Professor, Department of Psychiatry and Behavioral Sciences Professor, Department of Epidemiology & Population Health Edwin S. Lowe Chair in Neurology Vice Chair The Saul R. Korey Department of Neurology Director, Montefiore Headache Center Albert Einstein College of Medicine
Dr. Lipton

Opioids are not recommended in treatment guidelines as acute treatments for migraine.  Longitudinal studies show that in people with migraine treatment with opioids is associated with dose dependent acceleration of headache frequency and the development of chronic migraine in people with episodic migraine.  The purpose of this study was to determine the relative frequency of opioid use and the characteristics of those who use opioids to treat migraine. The hope is to use this information to develop programs which will encourage guideline compliant treatment.

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Studies Find Plant-Based Spray Can Provide Pain Relief from Inflammatory Skin Conditions

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PainRelief.com Interview with:
Markéta SAINT AROMAN, MD
Medical Director in Pierre Fabre Group.

Markéta SAINT AROMAN, MD

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

Response: Patients with inflammatory skin diseases frequently experience cutaneous pain as a symptom of their disease and may also experience burning and stinging sensations.

Signs and symptoms of inflammation are also experienced by patients who have undergone therapeutic and aesthetic skin resurfacing procedures (such as laser treatment, chemical peels and photodynamic therapy).

Diseases such as eczema (atopic dermatitis (AD), hand eczema) and psoriasis and dermatological procedures are all associated with disruption to the skin barrier which can expose cutaneous nerve endings, which are responsible for transmitting sensory information including itch and pain and increase sensitivity to environmental irritants. Heat sensations and oedema associated with inflammation also activate pain receptors. The impulse to scratch, which is a feature of AD and psoriasis and also occurs during the healing process following dermatological procedures, is a cause of cutaneous pain. At a molecular level, inflammation is characterized by the release of prostaglandins, cytokines, chemokines, proteases, neuropeptides, and growth factors, which are known to act directly on peripheral pain-sensing neurons.

The efficacy of the spray used in the study may be explained by the inclusion of two plant extracts demonstrated to have anti-inflammatory, immunomodulatory and antalgic activities.
The oat plantlet extract contains immumomodulatory saponins and anti-inflammatory flavonoids which inhibit the production of inflammatory mediators and stimulate keratinocyte proliferation and skin barrier repair. 

The extract of Uncaria tomentosa contains active compounds targeting peripheral pain sensation pathways.

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