Category Archives: Pain-Relief

Review of Compounded Topical Creams for Pain Relief

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PainRelief.com Interview with:


Debra A. Schwinn, M.D. (Committee Chair) – President-Elect of Palm Beach Atlantic University; former professor of anesthesiology, pharmacology, and biochemistry at the University of Iowa

Edmund J. Elder, Ph.D., R.Ph. – Director of the Zeeh Pharmaceutical Experiment Station, School of Pharmacy at the University of Wisconsin–Madison

·John T. Farrar, M.D., Ph.D. -Associate Professor of epidemiology and neurology, University of Pennsylvania School of Medicine 

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

Response: Compounding is the process of altering or combining ingredients to create medications that are tailored for an individual. Typically, compounded topical pain creams – which are applied to the skin in the form of gels, lotions, or ointments – are used by patients who cannot tolerate oral pain medications.

However, compounded topical preparations are not subject to the same level of extensive testing and stringent regulatory oversight as FDA-approved products. There are a number of safety concerns associated with their use, ranging from minor skin irritations to drug toxicity.

In response, FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to make recommendations for how the available scientific data on safety and effectiveness should inform future prescribing decisions.

PainRelief.com: What are the main findings?

Response: The report found there is limited scientific evidence to support the safety and effectiveness of compounded topical pain creams in adults. The committee assessed 20 Active Pharmaceutical Ingredients (APIs) that are commonly used in compounded topical pain creams. Out of the 20 APIs reviewed, 3 individual APIs and 1 two-drug combination demonstrate potential clinical effectiveness in compounded topical pain creams.

When possible, providers should prescribe FDA-approved products. Pharmacists and providers who prescribe compounded topical pain creams should also educate their patients about how much to use, which conditions to use it for, and the potential risks.

Among the report’s other findings about safety and effectiveness:

·         The rate and extent of the drug’s absorption into the skin and beyond is often unknown

·         There is no clear clinical rationale for specific combinations of APIs and dosages used

·         Labeling requirements for compounded preparations are often inadequate

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Individualized Footwear Provided Pain Relief in Patients with Knee Osteoarthritis

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PainRelief.com Interview with:
Peter Jüni, MD, FESC
Director, Applied Health Research Centre (AHRC)
Li Ka Shing Knowledge Institute of St. Michael’s Hospital
Canada Research Chair in Clinical Epidemiology of Chronic Diseases
Professor, Department of Medicine & 
Institute of Health Policy, Management and Evaluation 
University of Toronto

Dr-Peter Jüni
Dr. Peter Jüni

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

Response: Biomechanics plays an important role in the development of osteoarthritis of the knee. We did a 24-week randomized clinical trial of a novel individualized biomechanical footwear system.

The shoes have 2 convex pods on the outsoles that can be individually calibrated and may alter the biomechanics of the lower limb. The shoes should be used daily for progressively increasing amounts of time.

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At Home Therapy with Alpha-Stim Electrotherapy for Acute and Chronic Pain Relief

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PainRelief.com Interview with:
Steve Haltiwanger, MD, CCN, FAIS
Chief Medical Officer of Electromedical Products International, Inc.

PainRelief.com:  What is the background for the Alpha-Stim M CES/microcurrent therapy device? Where does the name come from?

Response: Before 1978 when the FDA changed the terminology, cranial electrotherapy stimulation (CES) was referred to as “electrosleep.” Early CES devices were used to induce sleep through the application of small amounts of electrical stimulation to the brain. As research progressed, many other effects were identified, including treatment of anxiety, depression, and pain./

Alpha-Stim M
Alpha-Stim M

A 1965 CES EEG study found that CES treatments increase the production of alpha rhythms in the brain (Magora et al., 1965). Increased alpha correlates with improved relaxation and increased mental alertness or clarity. In 2004 it was reported that Alpha-Stim CES treatments induced changes in the EEG, increasing alpha (8-12 Hz) relative power and decreasing relative power in the delta (0–3.5 Hz) and beta (12.5-30 Hz) frequencies (Kennerly, 2004).

In 1970 (Jarzembski et al.) determined that when CES was applied to the head of a primate, the electrical current penetrated every region of the brain with the flow notably channeled through the limbic system.

Many symptoms seen in psychiatric conditions, such as anxiety and insomnia, are found to be exacerbated by excess cortical activation (Yassa et al., 2012; Bonnet et al., 2010). An Alpha-Stim fMRI study in an anxiety population showed that CES, after one 20-minute treatment, causes cortical brain deactivation in the midline frontal and parietal regions of the brain (Feusner et al., 2012). Another fMRI study was conducted as part of a randomized, double-blind study in a pain population revealed more significant decreases in average pain levels (P=.023) than those using a sham device or receiving usual care without CES. The active CES device was shown to significantly decrease activation of central pain processing regions of the brain, such as the cingulate gyrus, insula, and prefrontal cortex, compared to the sham device (Taylor et al., 2013).

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Ethos Develops Biomarkers to Personalize Chronic Pain Relief

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PainRelief.com Interview with:

Brian Kincaid
Chief Executive Officer of Ethos Laboratories

https://www.ethos-labs.com/

How can reducing healthcare costs be achieved by the identification and validation of biomarkers through diagnosis and treatment of chronic pain?

Response:  Medicine has been evolving over the past couple of decades with a shift to personalized or targeted medicine.  As technology has improved and equipment capabilities have increased, the ability to identify and measure biomarkers is more affordable and accessible than ever before. Physicians now have access to more information specific to each individual patient, and as a result, can personalize treatment for each patient. 

Chronic pain is a very difficult disease for physicians to treat. The majority of assessments used by the physician are subjective in nature and rely heavily on accurate information provided by the patient, which can lead to unnecessary treatments. By adding an objective measurement as part of the chronic pain assessment, unnecessary treatments can be avoided and targeted treatments can be pursued. By reducing the number of unnecessary treatments, not only does the cost of care for the patient go down, but the quality of the care is improved. 

Using objective biomarkers as part of the chronic pain assessment will also provide some information on the viability of prescribing opioids at that time. Opioids will not help improve a patient’s biochemistry, and in some cases, opioids can have a negative effect on biochemistry. By treating abnormal biochemistry with safe inexpensive options first, it may be possible to avoid long term opioid prescribing for some patients, which would eliminate the costs associated with opioids in that patient subset.

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Acupuncture for Migraine Pain Relief

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PainRelief.com Interview with:

Prof. Wei Wang
Department of Neurology,
Tongji Hospital, Tongji Medical College,
Huazhong University of Science and Technology,
Wuhan, Hubei, P.R. China

acupuncture

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

Response: The burden of migraine is substantial, resulting in considerable economic and social losses. The latest Global Burden of Disease Study showed that 1.25 billion people had migraine in 2017. A significant number of patients are still not responding well to drug therapy, or cannot tolerate the adverse effects of drugs, or have contraindications, which can lead to low medication compliance, headache chronification and acute medication overuse. Prophylactic drugs should be recommended for migraineurs who have at least four headache days per month, but only 13% of patients reported current use of preventive drugs. Besides, ineffectiveness of and/or contraindications to migraine medication affect 10-15% of people with migraine. Hence, a need exists to investigate non-drug interventions.

Previous studies suggest that acupuncture works particularly well on a range of pain disorders. However, clinical evidence for the benefit of manual acupuncture for migraine prophylaxis remains scarce. Appropriate placebo control settings and successful blinding are two critical elements in addressing this challenge. Sham acupuncture involving penetrating needles should be avoided in clinical trials. Previous acupuncture research has often used penetrating sham acupuncture, involving needling non-acupuncture points, needling irrelevant acupuncture points, or superficial needling. However, whether the needle is inserted into an acupuncture point or a non-acupuncture point, it could produce a physiological effect. Comparisons between true acupuncture and sham acupuncture might also be biased by unsuccessful blinding. To ensure an inert placebo control and successful blinding, we recruited acupuncture-naive patients, using non-penetrating sham acupuncture at heterosegmental non-acupuncture points as the control, and designed the same procedures to perform the same rituals as much as possible in the manual and sham acupuncture groups.

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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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Targeting Specific Inflammatory Cells May Offer Enhanced Pain Relief

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PainRelief.com Interview with:
Prof. Dr. Halina Machelska
Department of Experimental Anesthesiology
Charité-Universitätsmedizin Berlin
Berlin, Germany

Prof. Dr. Halina Machelska Department of Experimental Anesthesiology Charité-Universitätsmedizin Berlin Berlin, Germany

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

Response: Pathological pain such as pain resulting from nerve injury is often accompanied by inflammation. This is manifested by accumulation of immune cells, including macrophages, in the damaged tissue. Current research mostly emphasizes the role of these cells in the enhancement of pain. One of the suggested strategies in the basic research is to deplete immune cells from the affected tissue. However, several previous preclinical studies, including our own, have shown that this approach did not sufficiently decrease pain. We think that one of the reasons is that not all immune cells invading damaged tissue are detrimental and in fact, some are needed there to counteract pain.

Macrophages are very heterogeneous and they comprise at least two subpopulations, pro-inflammatory M1 and anti-inflammatory M2 macrophages. Our idea in this study was to promote the analgesic properties of macrophages. We took advantage of the cytokine interleukin-4 (IL-4) to switch macrophages from the M1 to the M2 state.

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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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Animal Study Finds Ibuprofen for Pain Relief Can Cause Liver Damage

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PainRelief.com Interview with:
Aldrin V. Gomes, Ph.D., FAHA
Professor and Vice-Chair for Teaching,
Department of Neurobiology, Physiology, and Behavior
University of California, Davis
Davis, CA 95616

Dr. Gomes

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

Response: While many over the counter non-steroidal anti-inflammatory drugs (NSAIDs) now include a warning about potential cardiovascular disease, warnings about liver injury are hardly mentioned. This is because most NSAIDs including ibuprofen is considered to have very little potential to cause liver toxicity.

However, a 2018 publication (doi: https://doi.org/10.1016/j.cgh.2017.07.037) showed a relatively high prevalence of ibuprofen -induced liver injury in Spanish and Latin-American DILI (Drug induced liver injury) registries. As such, we were interested in determining what effects, if any, ibuprofen had on mice liver.

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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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