PainRelief.com Interview with: Rebecca Erwin Wells, MD, MPH Associate Professor, Department of Neurology UCNS Certified Headache Specialist Founder and Director of the Comprehensive Headache Program at Wake Forest Baptist Wake Forest School of Medicine
PainRelief.com: What is the background for this study?
Migraine is the second leading cause of disability worldwide.
Many patients with migraine stop medications because of side effects or ineffectiveness.
Many patients with migraine still use opioids despite recommendations against them for headache treatment.
Mindfulness is helpful for many clinical pain conditions.
We conducted a pilot study of mindfulness for migraine that demonstrated benefit, so we conducted this larger randomized controlled trial to understand further potential benefit.
PainRelief.com Interview with: Prof. Dr. Ernil Hansen Department of Anesthesiology University Hospital Regensburg Regensburg, Germany
Prof. Dr. Hansen
PainRelief.com: What is the background for this study? What are the main findings?
Response: It is becoming more and more clear that besides drugs and surgery it is communication that makes therapy effective. A meta-analysis we had conducted recently, suggested some beneficial effects of taped words played during surgery in older studies.
Our current study on 385 patients showed evidence that a text based on hypnotherapeutic principles an reduce postoperative pain and use of opioids. Pain within the first 24h after surgery decreased by 25%, opioid requirement by 34%. Six patients needed to be treated to save one patient from opioid exposure at all. High demand for analgesics was reduced by 41%.
PainRelief.com Interview with: Claudia Carvalho, PhD Instituto Universitário de Ciências Psicológicas Social e da Vida Lisbon, Portugal
PainRelief.com: What is the background for this study? What are the main findings?
Response: Some clinical trials on chronic pain have shown placebo responses that rival those of commonly prescribed first-line therapies for low back pain (LBP). However, prescribing placebos would pose ethical problems in clinical practice. One solution to this problem is the use of open label placebos (OLP), which are presented to patients openly as pills without active ingredients, along with a rationale indicating that because of classical conditioning of relief with active medications, the pills themselves might reduce pain. OLP has been shown effective compared to treatment-as-usual for a number of clinical conditions, including chronic LBP. Having conducted the first clinical trial on OLP on back pain, my colleagues and I wondered whether the effects were long-lasting. To answer that question, we conducted a five-year follow-up on the patients who had received OLP for their back pain.
In our original study, patients who took OLP pills for three weeks experienced greater reduction in back pain intensity and in back pain related disability than patients that simply continued their usual treatment. Additionally, after this phase of the trial, we offered OLP to participants in the treatment as usual group) and they also reported a significant reductions in pain and disability, together with a spontaneous decrease in the use of pain medication by participants.
PainRelief.com Interview with: Felix M. Gonzalez, M.D. Radiology Department at Emory University School of Medicine Atlanta, Georgia
PainRelief.com: What is the background for this study? What are the main findings?
Response: Arthritis afflicts 30 million Americans yearly with the most common form being degenerative arthritis. The main joints affected are the knee, hip and shoulder joints.
Osteoarthritis is exceedingly common, affecting more than 32.5 million Americans, according to the U.S. Centers for Disease Control and Prevention. The condition arises when the cartilage cushioning the joint breaks down over time, leading to pain, stiffness and decreased range of motion. People with osteoarthritis often take over-the-counter painkillers, such as ibuprofen (Advil, Motrin) and naproxen (Aleve). But besides being only moderately effective, the drugs are not without risks: Prolonged use is linked to increased risks of heart disease and kidney damage. Corticosteroid injections, which reduce inflammation, are the next option. But their effectiveness wanes over time and there are long-term safety issues, including a risk of cartilage damage.
Gonzalez and his colleagues treated 23 patients whose hip or shoulder pain had become so bad that anti-inflammatory painkillers and cortisone injections — two standard treatments — were no longer helping.
Before undergoing ablation, and again three months later, patients answered standard questionnaires gauging their pain and daily function.
In the end, the study found, patients with shoulder arthritis reported an 85% drop in their pain ratings, on average. Among hip arthritis patients, pain declined by an average of 70%.
Stéphane Potvin, PhD Centre de recherche Institut Universitaire en Santé Mentale de Montréal Full professor; Department of psychiatry and addiction University of Montreal
PainRelief.com: What is the background for this study? What are the main findings?
Dr. Potvin: Let’s begin by using a concrete example. First, imagine that you are taking a walk and it is really cold outside; so cold, in fact, that you can no longer enjoy the experience. Upon returning home, you realize that you no longer feel the pain, and you now have a smile on your face. During this sequence of events, what happened in your brain? To figure it out, we performed a functional neuroimaging study during which a painful cold gel was applied on the right foot of a group of healthy volunteers. What we discovered is that during pain stimulation, there was a clear de-activation of the medial orbito-frontal cortex, which is one of the main “pleasure” centers in the brain. Intriguingly, we observed that after the cold pain stimulation was discontinued, participants experienced significant levels of pleasant emotions that lasted for approximately 4 minutes.
PainRelief.com Interview with: Joshua (Shuki) Aviram PhD, R.N Prof. Meiri’s Laboratory of Cancer Biology and Cannabinoid Research Post doc Fellow Faculty of Biology Technion Institute of Technology – Haifa, Israel
Dr. Aviram
PainRelief.com: What is the background for this study? Response:I am a RN by profession, and treating patients with opioids as the main solution to alleviate their pain, with many adverse effects, such as severe constipation made me looking for another solution.
I reviewed the literature and I noticed that there were few reviews that used the same clinical trials as their basis, reaching somewhat different conclusions. Therefore, I decided to conduct a systematic review and meta-analysis of all available randomized controlled trials (RCTs) at that time.
MedicalResearch.com Interview with: Catherine Y. Chew, PharmD, BCGP Deputy Director, Division of Drug Information Center for Drug Evaluation and Research U.S. Food and Drug Administration
Dr. Chew
MedicalResearch.com: What actions is FDA taking regarding NSAID use during pregnancy?
Response: The U.S. Food and Drug Administration (FDA) is warning that use of prescription or over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) from around 20 weeks of pregnancy through the end of pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the unborn baby and possible complications.
For prescription NSAIDs, FDA is requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies; these kidney problems can result in low amniotic fluid. FDA is recommending that pregnant women avoid NSAIDs from around 20 weeks of pregnancy. Prescribing information already recommends avoiding NSAIDs from around 30 weeks through the end of pregnancy because NSAIDs can cause a problem that may result in heart issues in the unborn baby. If NSAID use is necessary between 20 and 30 weeks of pregnancy, NSAID use should be limited to the lowest effective dose for the shortest possible duration. Health care professionals should consider ultrasound monitoring of amniotic fluid if a pregnant woman uses NSAIDs beyond 48 hours.
FDA will also work with sponsors to request updates of the Drug Facts labels of OTC NSAIDs intended for use in adults. These labels already warn to avoid using NSAIDs during the last three months of pregnancy because the medicines may cause problems in the unborn baby or complications during delivery. The Drug Facts labels also already advise pregnant and breastfeeding women to ask a health care professional before using these medicines.
MedicalResearch.com: What did FDA find?
Response: These labeling changes are based on cases reported to FDA about low amniotic fluid levels or kidney problems in unborn babies associated with NSAID use during pregnancy. FDA’s medical literature review also contributed to the basis for the labeling changes.
Among the 35 cases of low amniotic fluid levels or kidney problems reported to FDA through 2017, all were serious. Two newborns who died had kidney failure and confirmed low amniotic fluid when mothers took NSAIDs while pregnant; three other newborns who died had kidney failure without confirmed low amniotic fluid when mothers took NSAIDs while pregnant. The low amniotic fluid levels started as early as 20 weeks of pregnancy. In 11 cases where low amniotic fluid levels were detected during pregnancy, the fluid volume returned to normal after the woman stopped taking the NSAID.
FDA’s medical literature review yielded similar findings. In these publications, low amniotic fluid levels were detected with NSAID use for varying amounts of time, ranging from 48 hours to multiple weeks. In most cases, the condition was reversible within three to six days after stopping the NSAID. In many reports, the condition was reversed when the NSAID was stopped; the condition reappeared when the same NSAID was started again.
MedicalResearch.com: What are NSAIDs? Are all NSAIDs included in the new FDA recommendations to avoid NSAID use from around 20 weeks through the end of pregnancy?
Response: For decades, people have used NSAIDs to treat pain and fever from many different long- and short-term medical conditions, such as arthritis, menstrual cramps, headaches, colds, and the flu. NSAIDs work by blocking the production of certain chemicals in the body that cause inflammation. There are both prescription and OTC NSAIDs.
NSAIDs are available alone and combined with other medicines for the temporary relief of pain and fever, including pain or fever symptoms associated with colds, flu, and insomnia. Examples of NSAIDs include ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac (Voltaren), and celecoxib (Celebrex) and aspirin.
An exception to these new FDA recommendations is the use of the low-dose aspirin (81 mg) for certain pregnancy-related conditions at any point in pregnancy under the direction of a health care professional. Low-dose aspirin may be an important treatment for some women during pregnancy. The recommendations also do not apply to NSAIDs administered directly to the eye.
MedicalResearch.com: NSAIDs already carry a warning about use in late pregnancy. What is different about these labeling changes?
Response: Warnings to avoid taking NSAIDs after about 30 weeks of pregnancy are already included in the prescribing information because taking these medications during this time may lead to heart issues in the unborn baby. The new labeling changes recommend avoiding NSAIDs as early as about 20 weeks of pregnancy because of the risk of kidney problems that result in low amniotic fluid.
MedicalResearch.com:What should pregnant women and health care professionals do? What are other options for pain relief during pregnancy?
Response: Women should not use NSAIDs after around 20 weeks in pregnancy unless specifically advised to do so by a health care professional. Because many OTC medicines contain NSAIDs, pregnant women should read the Drug Facts labels to determine if the medicines contain an NSAID. If pregnant women are unsure if a medicine contains an NSAID, they should ask a pharmacist or health care professional for help.
Other medicines, such as acetaminophen (Tylenol), are available to treat pain and fever during pregnancy. Pregnant women should ask their pharmacist or health care professional for help deciding which medication might be best.
Health care professionals should limit prescribing NSAIDs between 20 to 30 weeks of pregnancy and avoid prescribing them after 30 weeks of pregnancy. If NSAID treatment is determined necessary, health care professionals should limit use to the lowest effective dose and shortest duration possible. They should also consider ultrasound monitoring of amniotic fluid if the pregnant woman regularly uses NSAIDs longer than 48 hours and discontinue the NSAID if low amniotic fluid levels are found.
The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.
Brinda Krish, D.O., lead author of the study and an anesthesiology resident at Detroit Medical Center.
Padmavathi Patel, M.D., principal investigator of the study and Medical Director, Northstar Anesthesia at John D. Dingell Veteran Hospital.
PainRelief.com: What is the background for this study? What are the main findings?
Dr. Padmavathi Patel: Pain is a major contributor to health care costs and a common cause of long-term disability (about $61.2 billion/year) in lost productivity due to pain.
76.2 million Americans (one in four) have suffered from pain that lasts longer than 24 hours (2013).
Numerous literature such as:
1. “Use of prescription opioids in the treatment of pain has increased notably over recent decades.”
2. “Rates of death from prescribed opioids increased four fold between 2000 and 2014.”
3. “16,651 opioid related deaths in 2010.”
4. “The problem of opioid overuse and dependence is seen in the military as well as in civilian.”
-Opioid-related side effects could lead to a delay in recovery. -Pain control is more challenging for military population. -More extensive injuries and greater pain severity is seen in survivors of combat- related blast injuries compared to those of non-blast civilians and also they require larger opioid doses. -Pain is a very common patient complaint, both in veteran and non-veteran populations. -Among the 5.7 million unique patients seen annually with in the Department of Veterans Affairs (DVA), more than half of these patients experience chronic pain.
In 2017, The DVA and the United States Department of Defense (DoD) published an updated guidelines on opioid therapy for chronic pain that strongly recommends against initiation of long-term opioid use and recommends alternatives, including non-pharmacologic therapy, such as Acupuncture, which has been shown to be effective for treating a variety of painful conditions.
Acupuncture techniques have been in existence for centuries, with roots tied to Eastern Asia. Traditional acupuncture involves the insertion of very thin needles at specific trigger points around the body to relieve pain. Battlefield acupuncture (BFA), developed by a U.S. Air Force doctor uses needles that are inserted at various trigger points in the ear. In 2013, $5.4 million was awarded to the Departments of Defense and Veterans Affairs to teach BFA to healthcare providers in both the military and the Department of Veterans Affairs and assess it. In light of the opioid epidemic, there is a strong need to decrease perioperative opioid use. Opioid use due to postoperative pain along with perioperative anxiety has been linked to increased length of hospital stay, increased morbidity and mortality, and ultimately higher healthcare costs.
Battlefield acupuncture was introduced into Veterans Health Administration (VHA) in the last few years and in VHA, clinicians of various disciplines (MDs, DOs, PAs, nurse-practitioners), can currently obtain clinical privilege to provide it.
I received the Battlefield acupuncture training at John D. Dingell VA medical Center, Detroit and I was surprised with the outcomes of chronic pain patients. As an anesthesiologist I know pain after the surgery is common, often severe and largely unnecessary. I discussed these concerns with the surgeons and created the protocol to use BFA for general surgical patients and traditional acupuncture for hip replacement patients as an adjuvant to the standard protocol for acute post-surgical pain control.
Effective relief of postoperative pain is vital. Such pain probably prolongs hospital stay, as it can affect all the organ systems with side effects. Post op pain remains grossly under treated, with up to 70% of patients reporting moderate to severe pain following surgery.
Multimodal pain control not only can result in earlier discharge from hospital, but it may also reduce the onset of chronic pain syndromes.
2 studies performed TA (n=21), Controls given sham acupuncture (n=21). BFA (n=28), Controls given sham acupuncture (n=36). Measured variables included post-operative opioid requirements, postoperative pain, the incidence of PONV, and patient satisfaction scores
Key conclusions use of Battlefield acupuncture and Traditional acupuncture reduced post-operative opioid requirements, post-operative pain scores (pain intensity) and increased patient satisfaction scores. BFA also reduced PONV in patients.
PainRelief.com Interview with: Neda Gould, PhD Assistant Professor Director, Mindfulness Program at Johns Hopkins Associate Director, Bayview Anxiety Disorders Clinic Department of Psychiatry and Behavioral Sciences Johns Hopkins School of Medicine
PainRelief.com: What is the background for this study?
Response: Migraines can be severe and debilitating and many of the current pharmacological treatments have side effects. We were interested in studying the effect of a non-pharmacological intervention (mindfulness meditation) on migraines using various outcomes including brain imaging.
Mindfulness-Based Stress Reduction (MBSR) is a program that has been shown to improve chronic pain. However, the benefits of this program have been modest in migraine patients. We sought to determine if a longer period of mindfulness training and home practice would yield better outcomes in migraine patients.
The traditional MBSR course consists of 8 weekly sessions and a retreat. We enhanced this course to include the 8 weekly sessions and retreat followed by 4 additional biweekly sessions (MBSR +).
We randomized 98 adults with episodic migraine to the MBSR+ group (50 participants) or to a stress management for headache group (SMH, 48 participants). The SMH group included didactic content on stress and other triggers in headaches. Both groups followed a similar format and timing.
All participants completed questionnaires an also underwent magnetic resonance imaging (MRI) to look at changes in brain structure and function.
PainRelief.com Interview with: Sharon M Weinstein, MD, FAAHPM Neurology; Pain Medicine; Hospice and Palliative Medicine Professor of Anesthesiology and Adjunct Professor of Pediatrics University of Utah, Salt Lake City, Utah
PainRelief.com: What is the background for this study?
Response: I’ve been practicing pain medicine and palliative care for over 30 years. In the past several months since the onset of the coronavirus pandemic, I have learned a lot implementing telemedicine in different practice settings.
From the clinician’s perspective, the experience implementing telemedicine varies widely depending on tangible support provided. For example, having dedicated staff to instruct patients in the mechanics of telemedicine and having staff to “room” patients has been critical to my success. Having the health care system prepared with EHR infrastructures has also been essential to smooth operations.
The information on PainRelief.com is provided for educational purposes only, and is in no way intended to diagnose, endorese, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website. None of the content on PainRelief.com is warranted by the editors or owners of PainRelief.com or Eminent Domains Inc.
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