Virtual Reality Therapy Reduces Drug Use During Surgery

By Madora Pennington, PNN Columnist

Imagine going in for minor surgery, one where you don’t need to be totally unconscious, and being given a virtual reality headset for pain and anxiety relief instead of the usual dose of anesthesia.

The virtual reality (VR) device would distract you during surgery by immersing you in a nature scene, like a forest, mountain top or nighttime sky. And a guide meditation would reassure you with, “Surgery is going great! Try to stay still!”

Would this even work?

A small study led by researchers at the University of Colorado sought to find out by looking at 34 patients receiving hand surgery that could be done without general anesthesia. While virtual reality has been widely studied as a treatment for acute and chronic pain, researchers are just beginning to explore whether it can be used during surgery.

“In the field of anesthesia, we are constantly focused on improving patient safety and care quality,” said lead author Adeel Faruki, MD, an anesthesiologist at the University of Colorado Hospital. “There are many studies currently underway assessing if VR can be used for orthopedic joint surgeries.”

Faruki and his colleagues divided the patients into two groups. Half received the usual care and served as a control group, while the other half wore VR headsets and noise-cancelling headphones during surgery to promote relaxation and calmness. Both groups received local anesthesia and the sedative propofol, either upon patient request or at the discretion of an anesthesiologist.

Researchers found that patients in the VR group received significantly less propofol than those in the control group. Only four of the 17 patients in the VR group received any propofol during their surgery, while every patient in the control group received the sedative.

PLOS ONE

Not surprisingly, the VR patients tended to need more supplemental local anesthesia. Propofol can amplify the effectiveness of pain medication, so patients on propofol generally require less numbing and pain relief.

Patients in both groups reported their pain was well-controlled and they felt relaxed during surgery. There were no significant differences in their pain scores or surgery outcomes. In short, the VR group did just as well with the pleasant distraction of the device as those receiving more sedating medication.

There are advantages to using less propofol. The drug is commonly used as sedative during surgery, but poses risks because it tends to depress breathing, which is dangerous. “Acute propofol intoxication" was cited as the cause of pop star Michael Jackson’s overdose death in 2009.

Propofol is also hard on the brain and may cause lower cognition after surgery.  Being less drugged, patients who received VR were discharged from the postoperative recovery room an average of 22 minutes earlier than fully medicated patients. Getting patients released early frees hospital staff and resources for other patients and needs.

Some limitations the authors of the study acknowledge are that patients signing up for VR might be more likely to do well with less anesthesia if they volunteered for it. Neither the patients nor the healthcare providers were “blinded” in this study, meaning everyone knew which patients were getting VR and which ones weren’t. This scenario opens the possibility that providers participating in the study might inadvertently influence the results by giving the VR patients less propofol.

The bottom line for this study, which is being published in PLOS ONE, is that patients can have just as comfortable a surgery with less sedation when VR is used. The study does not prove that VR is better, just that it does as well as sedative medication.

Madora Pennington is the author of the blog LessFlexible.com about her life with Ehlers-Danlos Syndrome. Madora has tried virtual reality therapy and found it useful in reducing both pain and anxiety.  

Ketamine and Oxytocin Provide Pain Relief for Arachnoiditis

By Dr. Forest Tennant, PNN Columnist

Nearly every day we receive an email from someone who is having trouble getting enough pain medication to give them a good quality of life.  In this age of opioid restrictions, there is hope. 

In the past, opioids and gamma amino butyric acid (GABA) substitutes such as diazepam (Valium) and gabapentin (Neurontin) have been the mainstays for pain control of adhesive arachnoiditis (AA). Today, there are alternatives that can enhance your current program to give you better pain control.

Low dose naltrexone is the initial pain reliever recommended to newly diagnosed AA cases. There are two other potent pain relievers that can be used with both naltrexone and opioids to achieve better pain relief: ketamine and oxytocin. Either agent is a good opioid substitute.

Ketamine provides pain relief primarily by suppressing a nerve receptor called N-methyl-d-aspartate. It can be taken by several non-oral routes of administration: nasal, injectable, sublingual or troche (dissolvable tablet).

Oxytocin (not to be confused with oxycodone or OxyContin) is a hormone that is a natural pain reliever. It surges in a woman’s body at the time of delivery to provide pain relief. It acts by activating the endorphin (opioid) receptors and by blocking nerve impulses between the brain and spinal cord.

Every community now has one or more pharmacies that will compound or “make” formulations of ketamine or oxytocin. We favor under-the-tongue (sublingual) or buccal (cheek) formulations.

Ketamine and/or oxytocin can be taken between opioid dosages or within 5 to 10 minutes before or after an opioid dosage to make the opioid stronger and last longer.

Ketamine and oxytocin can be used separately or used as combination therapy. Starting dosages of ketamine are 10-15 mg and oxytocin 10-20 units, which are administered within 10 minutes of each other. Dosages can later be raised above the starting dose.

We find the combination of ketamine and oxytocin to provide equal or better pain relief that most prescription opioids. Neither ketamine nor oxytocin are opioids, so there is no bias or resistance to their use. Also, overdoses are essentially not known to occur with regular dosages.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from a bulletin recently issued by the Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

‘Cognitive Rehab’ May Help Clear Brain Fog

By Judith Graham, Kaiser Health News

Eight months after falling ill with covid-19, the 73-year-old woman couldn’t remember what her husband had told her a few hours before. She would forget to remove laundry from the dryer at the end of the cycle. She would turn on the tap at a sink and walk away.

Before covid, the woman had been doing bookkeeping for a local business. Now, she couldn’t add single-digit numbers in her head. Was it the earliest stage of dementia, unmasked by covid? No. When a therapist assessed the woman’s cognition, her scores were normal.

What was going on? Like many people who’ve contracted covid, this woman was having difficulty sustaining attention, organizing activities, and multitasking. She complained of brain fog. She didn’t feel like herself.

But this patient was lucky. Jill Jonas, an occupational therapist associated with the Washington University School of Medicine in St. Louis who described her to me, has been providing cognitive rehabilitation to the patient, and she is getting better.

Cognitive rehabilitation is therapy for people whose brains have been injured by concussions, traumatic accidents, strokes, or neurodegenerative conditions such as Parkinson’s disease. It’s a suite of interventions designed to help people recover from brain injuries, if possible, and adapt to ongoing cognitive impairment. Services are typically provided by speech and occupational therapists, neuropsychologists and neurorehabilitation experts.

In a recent development, some medical centers are offering cognitive rehabilitation to patients with long covid, who have symptoms that persist several months or longer after the initial infection. According to the Centers for Disease Control and Prevention, about 1 in 4 older adults who survive covid have at least one persistent symptom.

“Anecdotally, we’re seeing a good number of people make significant gains with the right kinds of interventions,” said Monique Tremaine, director of neuropsychology and cognitive rehabilitation at Hackensack Meridian Health’s JFK Johnson Rehabilitation Institute in New Jersey.

Among the post-covid cognitive complaints being addressed are problems with attention, language, information processing, memory, and visual-spatial orientation. A recent review in JAMA Psychiatry found that up to 47% of patients hospitalized in intensive care with covid developed problems of this sort.

Seniors More Vulnerable

There’s emerging evidence that seniors are more likely to experience cognitive challenges post-covid than younger people — a vulnerability attributed, in part, to older adults’ propensity to have other medical conditions. Cognitive challenges arise because of small blood clots, chronic inflammation, abnormal immune responses, brain injuries such as strokes and hemorrhages, viral persistence, and neurodegeneration triggered by covid.

Getting help starts with an assessment by a rehabilitation professional to pinpoint cognitive tasks that need attention and determine the severity of a person’s difficulties. One person may need help finding words while speaking, for instance, while another may need help with planning and yet another may not be processing information efficiently. Several deficits may be present at the same time.

Next comes an effort to understand how patients’ cognitive issues affect their daily lives. Among the questions that therapists will ask, according to Jason Smith, a rehabilitation psychologist at the University of Texas Southwestern Medical Center in Dallas: “Is this showing up at work? At home? Somewhere else? Which activities are being affected? What’s most important to you and what do you want to work on?”

To try to restore brain circuits that have been damaged, patients may be prescribed a series of repetitive exercises. If attention is the issue, for instance, a therapist might tap a finger on the table once or twice and ask a patient to do the same, repeating it multiple times. This type of intervention is known as restorative cognitive rehabilitation.

“It isn’t easy because it’s so monotonous and someone can easily lose attentional focus,” said Joe Giacino, a professor of physical medicine and rehabilitation at Harvard Medical School. “But it’s a kind of muscle building for the brain.”

A therapist might then ask the patient to do two things at once: repeat the tapping task while answering questions about their personal background, for instance.

“Now the brain has to split attention — a much more demanding task — and you’re building connections where they can be built,” Giacino explained.

To address impairments that interfere with people’s daily lives, a therapist will work on practical strategies with patients. Examples include making lists, setting alarms or reminders, breaking down tasks into steps, balancing activity with rest, figuring out how to conserve energy, and learning how to slow down and assess what needs to be done before taking action.

A growing body of evidence shows that “older adults can learn to use these strategies and that it does, in fact, enhance their everyday life,” said Alyssa Lanzi, a research assistant professor who studies cognitive rehabilitation at the University of Delaware.

Along the way, patients and therapists discuss what worked well and what didn’t, and practice useful skills, such as using calendars or notebooks as memory aids.

“As patients become more aware of where difficulties occur and why, they can prepare for them and they start seeing improvement,” said Lyana Kardanova Frantz, a speech therapist at Johns Hopkins University. “A lot of my patients say, ‘I had no idea this could be so helpful.’”

Johns Hopkins has been conducting neuropsychiatric exams on patients who come to its post-covid clinic. About 67% have mild to moderate cognitive dysfunction at least three months after being infected, said Dr. Alba Miranda Azola, co-director of Johns Hopkins’ Post-Acute COVID-19 Team. When cognitive rehabilitation is recommended, patients usually meet with therapists once or twice a week for two to three months.

Before this kind of therapy can be tried, other problems may need to be addressed. “We want to make sure that people are sleeping enough, maintaining their nutrition and hydration, and getting physical exercise that maintains blood flow and oxygenation to the brain,” Frantz said. “All of those impact our cognitive function and communication.”

Depression and anxiety — common companions for people who are seriously ill or disabled — also need attention. “A lot of times when people are struggling to manage deficits, they’re focusing on what they were able to do in the past and really mourning that loss of efficiency,” Tremaine said. “There’s a large psychological component as well that needs to be managed.”

Medicare usually covers cognitive rehabilitation, but Medicare Advantage plans may differ in the type and length of therapy they’ll approve and how much they’ll reimburse providers — an issue that can affect access to care.

Still, Tremaine noted, “not a lot of people know about cognitive rehabilitation or understand what it does, and it remains underutilized.” She and other experts don’t recommend digital brain-training programs marketed to consumers as a substitute for practitioner-led cognitive rehabilitation because of the lack of individualized assessment, feedback, and coaching.

Also, experts warn, while cognitive rehabilitation can help people with mild cognitive impairment, it’s not appropriate for people who have advanced dementia.

If you’re noticing cognitive changes of concern, ask for a referral from your primary care physician to an occupational or speech therapist, said Erin Foster, an associate professor of occupational therapy, neurology, and psychiatry at Washington University School of Medicine in St. Louis. Be sure to ask therapists if they have experience addressing memory and thinking issues in daily life, she recommended.

“If there’s a medical center in your area with a rehabilitation department, get in touch with them and ask for a referral to cognitive rehabilitation,” said Smith, of UT Southwestern Medical Center. “The professional discipline that helps the most with cognitive rehabilitation is going to be rehabilitation medicine.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

Physical Therapy Reduces Healthcare Costs for Low Back Pain

By Pat Anson, PNN Editor

Almost everyone suffers from low back pain at some point in their lives. Most recover in a few days, but for some the pain lingers and become chronic, making low back pain the world’s leading cause of disability.  

Why are some people able to recover quickly from low back pain?

For many, the answer may be early treatment with physical therapy (PT), according to a new study by researchers at Johns Hopkins Medicine.   

“Our goal was to determine if early PT for patients with lower back pain had an impact on their overall health care resource utilization,” says senior author Richard Skolasky Jr., ScD, director of the Johns Hopkins Spine Outcomes Research Center. “We were especially curious about the 30 days after initial symptom onset, as this is when patients are most likely to seek care.” 

Skolasky and his colleagues analyzed healthcare data from 2010 to 2014 for nearly a million U.S. adults with acute low back pain, excluding those suffering from serious disorders such as arthritis or spinal cord injuries. About 10% of the patients received early treatment with physical therapy.

The study findings, recently published by BMC Health Services Research, showed that patients getting early PT were significantly less likely to see a chiropractor, orthopedic surgeon or pain specialist after 30 days than those who did not get physical therapy. They were also less likely to get advanced imaging, epidural steroid injections or to visit an emergency room.

Researchers estimate that healthcare costs for a typical patient getting early PT was about $500 less over 30 days than those not receiving physical therapy.

Another key finding from the study was significant geographical differences in the use of physical therapy. Patients in the West (16%) and Northeast (15%) were nearly twice as likely to get early PT than those in the Midwest (9.4%) and South (8.6%). The authors offered no explanation for why treatment patterns varied so much by region.

The study did not specifically examine whether physical therapy benefits patients with low back pain more than other forms of treatment, but the findings suggest that they did. Researchers say health outcomes should be examined more closely in future studies.

“As the U.S. population ages, the prevalence of lower back pain is expected to increase, along with the associated costs of treating it,” says Skolasky. “Furthermore, with advances in imaging and treatments, the cost of managing lower back pain has increased substantially. Our findings have important implications that may guide health care policy when examining downstream health care costs and resource utilization.” 

Previous studies have found that physical therapy and regular exercise significantly reduces low back pain. Other studies also found little evidence to support the use of opioids, spinal injections and acetaminophen for low back pain.  

‘No Pain, No Gain’ Approach Helps People With Peripheral Artery Disease

By Pat Anson, PNN Editor

“No pain, no gain” is a phrase that caught on in the 1980’s when fitness videos promoting aerobic exercise became popular. Most doctors today will say that’s bad advice, because physical pain during exercise could be a sign of a serious injury or health problem. Pain is your body’s way of warning you that something is wrong.  

But it turns out that pain and discomfort while walking for exercise may actually be a good thing for people with peripheral artery disease – PAD for short – a condition that occurs when arteries become narrow or clogged, reducing the flow of blood and oxygen throughout the body.

In a new study published in the Journal of the American Heart Association, researchers reported that people with PAD who experienced cramping, soreness, fatigue and other ischemic leg symptoms while walking may actually benefit from the pain.

“We were surprised by the results because walking for exercise at a pace that induces pain in the legs among people with PAD has been thought to be associated with damage to leg muscles,” said senior author Mary McDermott, MD, an Internal Medicine and Geriatric Professor at Northwestern University’s Feinberg School of Medicine. “Based on these results, clinicians should advise patients to walk for exercise at a pace that induces leg discomfort, instead of at a comfortable pace without pain.”

McDermott and her colleagues followed 264 mostly elderly people with PAD for 12 months, randomly assigning them to one of three groups. The first group walked at home at a comfortable pace; the second group walked at a faster pace that induced ischemic leg symptoms; and the third group did not walk for exercise.

Participants who walked were asked to exercise 5 days per week for up to 50 minutes, while wearing an ActiGraph, a device that monitored the intensity and duration of their walking.

After six months, researchers found that people who walked at a pace that induced ischemic leg symptoms walked significantly faster in daily life than those who did not exercise or walked at a comfortable pace without leg symptoms. They also performed better on a physical performance test that assessed their speed, strength and balance. The findings were similar after 12 months.

“This finding is consistent with ‘no pain, no gain’ with regard to walking exercise in PAD,” McDermott said in a press release. “Exercise that induces leg pain is beneficial, though difficult.

“We now are working to identify interventions that can make the higher intensity exercise easier -- and still beneficial -- for people with PAD.”

Between 8 and 10 million people in the United States have PAD. The condition disproportionately affects African-Americans, Native Americans and those with low socioeconomic status.

Previous research found that walking for exercise improves walking ability and walking distance for people with PAD. What remained unclear, until now, were the potential effects of walking at a pace that induced symptoms such as leg pain.

The American Heart Association and 24 other organizations recently launched the PAD National Action Plan, a guide to assist in the prevention of PAD complications, reduce cardiovascular risk, and improve quality of life for those living with the disease.

“PAD is a lifelong medical condition, but people with PAD can lead active and long lives,” said Joshua Beckman, MD, professor of medicine at Vanderbilt University. “If you notice walking is becoming more difficult, keeping up with others is hard, or you have pain when you walk, talk with a doctor and describe when it happens and how it feels.” 

A recent study found that walking for exercise is also beneficial for people with osteoarthritis, who experienced 40% less knee pain than non-walkers.

Electromedical Treatments for Arachnoiditis

By Dr. Forest Tennant, PNN Columnist  

Adhesive Arachnoiditis (AA) is an inflammatory, nerve root entrapment disease in which cauda equina nerve roots are glued by adhesions to the arachnoid-dural covering of the spinal canal. An inflamed tumor-like mass is formed inside the spinal canal that blocks spinal fluid flow, allows seepage of fluid into tissue outside the spinal canal and shuts off electrical impulses that activate the legs, feet, bladder, intestine and sex organs. Autoimmunity is produced and/or magnified by AA. 

We highly recommend a three-component protocol for AA to reduce inflammation and autoimmunity, regenerate damaged tissue and to provide pain control. Recent advances in electromedical therapies can help achieve these three goals. 

There are two basic types of electromedical devices available for AA treatment: electric current therapy (EC) and electromagnetic therapy (EM). 

Electric Current Therapy 

Almost everyone is familiar with “TENS” units, which stands for “transcutaneous electrical nerve stimulation.” These devices were the first electromedical therapies to relieve pain and promote healing.

TENS units deliver a single electric current into tissues to produce an anesthetic, pain relieving effect.  

Today, more advanced EC devices administer micro-currents and/or a combination of multiple currents with different frequencies. 

Electromagnetic Therapy 

There is a form of energy that is half electricity and half magnetism, which can be divided into wave lengths. The very shortest wave of electromagnetic energy is “atomic” and the longest is “radio.” The shortest wave used in medicine is “laser.” Other electromagnetic energy waves used for medical purposes include infrared, light and microwave. 

EC and EM devices, when placed over the lower back, deliver electric current or electromagnetic energy to the lumbar-sacral spinal canal and the spine’s surrounding tissue.

Modern devices use intermittent pulsation of electric currents or electromagnetic energy to penetrate the skin and subcutaneous tissue to reach the AA site, which is usually about 2-3 inches below the skin.  

Some devices use the label PEMF, which stands for “pulsed electromagnetic frequency.” We believe that the newer EC and EM devices can deliver electric currents or electromagnetic energy that, when pulsed, penetrate deep enough to reach the AA disease site. 

Although not totally curative, these devices usually bring about pain reduction in the 20 to 30% range. Within an individual’s financial capability, we recommend that an EC and/or EM device be used 2 to 3 times a week (not daily). EC and EM therapy are not substitutes for a medical protocol. 

EM and EC devices often produce some initial healing, but later seem to stop working. In this situation the device may have done its maximal healing. The devices can still be used periodically to prevent relapses and treat flares. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from a bulletin recently issued by the Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

Dr. Tennant’s new book, "Clinical Diagnosis and Treatment of Adhesive Arachnoiditis” is available on Amazon. 

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

Popular Exercises for Persons with Arachnoiditis

By Dr. Forest Tennant, PNN Columnist 

Adhesive Arachnoiditis (AA) is an inflammatory, nerve root entrapment disease in which cauda equina nerve roots are glued by adhesions to the arachnoid-dural covering of the spinal canal. An inflamed tumor-like mass is formed inside the spinal canal that blocks spinal fluid flow, allows seepage of fluid into tissue outside the spinal canal, and shuts off electrical impulses that activate the legs, feet, bladder, intestine and sex organs.  

Some specific exercises help neutralize the deleterious effects of AA and promote regeneration of damaged tissue.  We surveyed 40 persons with MRI-documented AA to determine which exercises they found most beneficial.

The top five are listed here in descending order of popularity. 

1. Water Soaking: It is no surprise this is No.1. Water soaking pulls out toxins and excess electricity and relaxes muscles. All types of water soaking are good: pool, jacuzzi, shower, tub, hot/wet towel. Epsom Salts in water mimic the mineral baths used therapeutically by ancient peoples. 

2. Massage: Kneading of back muscles causes any seepage of spinal fluid to mobilize and causes spinal fluid to keep moving around the AA blockage in the spinal canal. 

3. Walking: Nerve roots that activate the legs and feet can become so inflamed and entrapped that one can’t walk. Short daily walks are essential to prevent the development of paralysis and weakness. 

4. Arm & Leg Stretching: Entrapped nerve roots in the AA mass decrease the normal leg, arm, and foot fidgets and movements that occur every few minutes even while sleeping. Arm and leg stretching will keep the lower back muscles from contracting or shrinking which, over time, will increase back pain. 

5. Deep Breathing: Deep breathing and short breath-holds bring oxygen to the spinal canal to promote healing. It will also help keep spinal fluid moving. Deep breathing is best done while standing but it can be done while sitting and watching TV, driving, or eating. 

Other exercises compliment the AA medical treatment protocol. Besides those listed here, we also advocate light weightlifting, rocking, bicycling, and trampoline walking. 

Credit: Lynn Ashcraft did the data analysis of this survey. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from a bulletin recently issued by the Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

Dr. Tennant’s new book, "Clinical Diagnosis and Treatment of Adhesive Arachnoiditis” is available on Amazon. 

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

Migraine Sufferers Have Treatment Options Besides Medication

By Dr. Danielle Wilhour

Migraine headaches currently affect more than one billion people across the globe and are the second-leading cause of disability worldwide. Nearly one-quarter of U.S. households have at least one member who suffers from migraines. An estimated 85.6 million workdays are lost as a result of migraine headaches each year.

Yet many who suffer with migraine dismiss their pain as simply a bad headache. Rather than seeking medical care, the condition often goes undiagnosed, even when other incapacitating symptoms occur alongside the pain, including light and sound sensitivity, nausea, vomiting and dizziness.

Researchers have discovered that genetics and environmental factors play a role in the condition of migraine. They happen when changes in your brainstem activate the trigeminal nerve, which is a major nerve in the pain pathway. This cues your body to release inflammatory substances such as CGRP, short for calcitonin gene-related peptide. This molecule, and others, can cause blood vessels to swell, producing pain and inflammation.

Medication Has Its Limits

A migraine can be debilitating. Those who are experiencing one are often curled up in a dark room accompanied by only their pain. Attacks can last for days; life is put on hold. The sensitivity to light and sound, coupled with the unpredictability of the disease, causes many to forego work, school, social gatherings and time with family.

Numerous prescription medications are available for both the prevention and treatment of migraine. But for many people, conventional treatment has its limitations. Some people with migraine have a poor tolerance for certain medications. Many can’t afford the high cost of the medicines or endure the side effects. Others are pregnant or breastfeeding and can’t take the medications.

However, as a board-certified neurologist who specializes in headache medicine, I’m always amazed at how open-minded and enthusiastic patients become when I discuss alternative options.

Your brain sends you warning signals, such as fatigue and mood changes, to let you know a migraine may be on the way.

These approaches, collectively, are called complementary and alternative medicine. It might be surprising that a traditionally trained Western doctor like me would recommend things like yoga, acupuncture or meditation for people with migraine. Yet in my practice, I value these nontraditional treatments.

Research shows that alternative therapies are associated with improved sleep, feeling better emotionally and an enhanced sense of control. Some patients can avoid prescription medications altogether with one or more complementary treatments. For others, the nontraditional treatments can be used along with prescription medication.

These options can be used one at a time or in combination, depending on how severe the headache and the cause behind it. If neck tension is a contributor to the pain, then physical therapy or massage may be most beneficial. If stress is a trigger, perhaps meditation would be an appropriate place to start. It is worth talking to your provider to explore which options may work best for you.

Mindfulness and Meditation

Because stress is a major trigger for migraines, one of the most effective alternative therapies is mindfulness meditation, which is the act of focusing your attention on the present moment in a nonjudgmental mindset. Studies show that mindfulness meditation can reduce headache frequency and pain severity.

Another useful tool is biofeedback, which enables a person to see their vital signs in real time and then learn how to stabilize them.

For example, if you are stressed, you may notice muscle tightness, perspiration and a fast heart rate. With biofeedback, these changes appear on a monitor, and a therapist teaches you exercises to help manage them. There is strong evidence that biofeedback can lessen the frequency and severity of migraine headaches and reduce headache-related disability.

Yoga derives from traditional Indian philosophy and combines physical postures, meditation and breathing exercises with a goal of uniting the mind, body and spirit. Practicing yoga consistently can be helpful in reducing stress and treating migraine.

Meditation is an alternative therapy that could help with your migraine.

Physical Therapy

Physical therapy uses manual techniques such as myofascial and trigger-point release, passive stretching and cervical traction, which is a light pulling on the head by a skilled hand or with a medical device. Studies show that physical therapy with medication was superior in reducing migraine frequency, pain intensity and pain perception over medications alone.

By lowering stress levels and promoting relaxation, massage can decrease migraine frequency and improve sleep. It may also reduce stress in the days following the massage, which adds further protection from migraine attacks.

Some patients are helped by acupuncture, a form of traditional Chinese medicine. In this practice, fine needles are placed in specific locations on the skin to promote healing. A large 2016 meta-analysis paper found acupuncture reduced the duration and frequency of migraines regardless of how often they occur. Acupuncture benefits are sustained after 20 weeks of treatment.

What’s also fascinating is that acupuncture can change the metabolic activity in the thalamus, the region of the brain critical to pain perception. This change correlated with a decrease in the headache intensity score following acupuncture treatment.

Vitamins, Supplements and Nutraceuticals

Herbal supplements and nutraceuticals, which are food-derived products that may have therapeutic benefit, can also be used to prevent migraine. And there is evidence to suggest vitamins work reasonably well compared to traditional prescription medication. They also have fewer side effects. Here are some examples:

• Magnesium is believed to help regulate the blood vessels and electrical activity in the brain. A study found that patients given 600 milligrams of magnesium citrate daily for 12 weeks had a 40% decrease in migraine. Side effects included diarrhea in nearly 20% of patients.

• Vitamin B2, or riboflavin, is also considered useful in migraine prevention. When dosed at 400 milligrams daily for 12 weeks, researchers found it reduced migraine frequency by half in more than half of participants.

• Another beneficial supplement is Coenzyme Q10, which is involved in cellular energy production. After three months, about half of those taking 100 milligrams of Coenzyme Q10 three times a day had half the number of migraine attacks.

• A potential natural solution is feverfew or Tanacetum parthenium, a daisylike perennial plant known to have anti-migraine properties. Taken three times daily, feverfew reduced migraine frequency by 40%.

Medical Devices

The Food and Drug Administration has approved several neurostimulation devices for migraine treatment. These devices work by neutralizing the pain signals sent from the brain.

One is the Nerivio device, which is worn on the upper arm and sends signals to the brainstem pain center during an attack. Two-thirds of people report pain relief after two hours, and side effects are rare.

Another device that shows promise is the Cefaly. It delivers a mild electrical current to the trigeminal nerve on the forehead, which can lessen the frequency and intensity of migraine attacks. After one hour of treatment, patients experienced a nearly 60% reduction in pain intensity, and the relief lasted up to 24 hours. Side effects are uncommon and include sleepiness or skin irritation.

These alternative therapies help treat the person as a whole. In just my practice, many success stories come to mind: the college student who once had chronic migraine but now has rare occurrences after a regimen of vitamins; the pregnant woman who avoided medication through acupuncture and physical therapy; or the patient, already on numerous prescription medications, who uses a neurostimulation device for migraine instead of adding another prescription.

Granted, alternative approaches are not necessarily miracle therapies, but their potential to relieve pain and suffering is notable. As a physician, it is truly gratifying to see some of my patients respond to these treatments.

Danielle Wilhour, MD, is an Assistant Professor of Neurology, University of Colorado Anschutz Medical Campus. Her primary interests include non-pharmacologic treatment of headache as well as headache during pregnancy.  Danielle does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article.

This article originally appeared in The Conservation and is republished with permission.

Experimental Implant Uses Coolant to Numb Nerve Pain

By Pat Anson, PNN Editor

Applying ice on inflamed tissues and sore muscles is one of the oldest ways to relieve pain and promote healing.  Researchers at Northwestern University are taking that tried-and-true method a step further, with the development of a small, flexible implant that can alleviate pain by literally cooling nerves.

Researchers believe the experimental implant could be most beneficial to patients who undergo surgeries, nerve grafts or even amputations. Surgeons could implant the device during the procedure to help patients manage post-operative pain on demand without the use of drugs.

“As engineers, we are motivated by the idea of treating pain without drugs — in ways that can be turned on and off instantly, with user control over the intensity of relief,” says John Rogers, PhD, Professor of Materials Science and Engineering at Northwestern and lead author of a study published in the journal Science.

“The technology reported here exploits mechanisms that have some similarities to those that cause your fingers to feel numb when cold. Our implant allows that effect to be produced in a programmable way, directly and locally to targeted nerves, even those deep within surrounding soft tissues.”

In experiments on laboratory rats, Rogers and his colleagues demonstrated that the implants can rapidly cool peripheral nerves to relieve neuropathic pain.

As thick as a sheet of paper, at its widest point the implant is 5 millimeters wide – about the size of the eraser on a pencil. One end is curled into a cuff that can softly wrap around a nerve, without the need for sutures to hold it in place.

“If you think about soft tissues, fragile nerves and a body that’s in constant motion, any interfacing device must have the ability to flex, bend, twist and stretch easily and naturally,” said Rogers.

NORTHWESTERN UNIVERSITY

To induce cooling, the device contains tiny microfluid channels. One channel contains a liquid coolant (perfluoropentane), while a second channel contains dry nitrogen. When the liquid and gas flow into a shared chamber, a reaction occurs that causes the liquid to evaporate and cool. A tiny sensor in the implant monitors the temperature of the nerve to ensure that it’s not getting too cold, which could cause tissue damage.

“As you cool down a nerve, the signals that travel through the nerve become slower and slower — eventually stopping completely,” said coauthor Matthew MacEwan, PhD, from Washington University School of Medicine in St. Louis. “We are specifically targeting peripheral nerves, which connect your brain and your spinal cord to the rest of your body. These are the nerves that communicate sensory stimuli, including pain. By delivering a cooling effect to just one or two targeted nerves, we can effectively modulate pain signals in one specific region of the body.”

An external pump allows patients to remotely activate the implant and increase or decrease its intensity. Because the device is biocompatible and water-soluble, it will naturally dissolve and absorb into the body over the course of days or weeks — bypassing the need for surgical extraction.

Other cooling therapies have been tested experimentally, but have limitations. Instead of targeting specific nerves, they cool large areas of tissue, potentially leading to side effects such as tissue damage and inflammation.

“You don’t want to inadvertently cool other nerves or the tissues that are unrelated to the nerve transmitting the painful stimuli,” MacEwan said. “We want to block the pain signals, not the nerves that control motor function and enables you to use your hand, for example.”

Walking Reduces Pain From Knee Osteoarthritis

By Pat Anson, PNN Editor

It may seem counterintuitive, but a new study suggests that walking may be the best medicine to reduce knee pain from osteoarthritis.

Nearly 40 percent of Americans over the age of 45 have some degree of knee osteoarthritis, a progressive joint disorder caused by inflammation of soft tissue, which leads to thinning of cartilage and joint damage. Osteoarthritis (OA) of the knee is not to be taken lightly, as studies have found that it is strongly associated with early death, high blood pressure, diabetes, elevated cholesterol and cardiovascular disease, particularly for women.

Moderate exercise like walking may help prevent all of those health problems.

In a multi-year study of 1,212 people over the age of 50, researchers at Baylor College of Medicine found that participants who walked for exercise at least 10 times had 40% less risk of developing frequent knee pain than non-walkers.

“Until this finding, there has been a lack of credible treatments that provide benefit for both limiting damage and pain in osteoarthritis,” said Grace Hsiao-Wei Lo, MD, assistant professor of Immunology, Allergy and Rheumatology at Baylor and lead author of the study published in Arthritis & Rheumatology.

“These findings are particularly useful for people who have radiographic evidence of osteoarthritis but don’t have pain every day in their knees,” Lo explained in a press release. “This study supports the possibility that walking for exercise can help to prevent the onset of daily knee pain.  It might also slow down the worsening of damage inside the joint from osteoarthritis.”  

Lo says walking for exercise has other health benefits, such as improved cardiovascular health and decreased risk of obesity, diabetes and even some cancers. Walking is also a free activity with minimal side effects.

“People diagnosed with knee osteoarthritis should walk for exercise, particularly if they do not have daily knee pain,” says Lo, who is chief of rheumatology at the Michael E. DeBakey VA Medical Center in Houston. "If you already have daily knee pain, there still might be a benefit, especially if you have the kind of arthritis where your knees are bow-legged.”

FTC Sues Footwear Company Over Pain Relief Claims

By Pat Anson, PNN Editor

The U.S. Federal Trade Commission has filed a lawsuit against a California footwear company, alleging it makes false claims that its shoes can relieve knee, back and foot pain. It’s the latest salvo in a long-running legal battle between the FTC and the Gravity Defyer Medical Technology Corporation.

According to the FTC complaint, Gravity Defyer and its owner, Alexander Elnekaveh, violated a 2001 order barring him from using deceptive advertising that makes unsupported scientific claims. The FTC says the company’s ads target people aged 55 and older, telling them its “pain defying footwear” made with “hybrid VersoShock technology” can relieve suffering from arthritis, joint pain, plantar fasciitis and heel spurs.

“Ignoring a prior Commission order, Gravity Defyer and its owner used false pain-relief claims to target older Americans and undercut honest competitors,” Samuel Levine, Director of the FTC’s Bureau of Consumer Protection, said in a statement. “Health-based claims require science-based proof, and faking it by misusing studies and customer reviews breaks the law.”

The 2001 FTC order stems from another company operated by Elnekave, which sold a magnetic fuel-line device that allegedly could reduce gasoline consumption by as much as 27 percent. The FTC says those claims were false and misleading.

Gravity Defyer sells an expensive line of athletic shoes, casual shoes, dress shoes, hiking shoes, boots and sandals for men and women.

They range in price from $140 for a pair of sandals to $235 for work boots.

The company sells the shoes on its website, Amazon and at retailers around the country, including The Walking Company, Hammacher Schlemmer, and Shoe City. It advertises its products on Arthritis Today and WebMD, as well as numerous other publications and websites.

Asked to comment on the FTC complaint, the company sent a statement to PNN claiming that its First Amendment right to free speech was being violated.

GRAVITY DEFYER AD

“Gravity Defyer apprised the FTC of the obvious logical flaws in its stance – and that its stance violates Gravity Defyer’s First Amendment right to disseminate, and consumers’ right to receive, truthful, non-misleading scientific information. The FTC was unrelenting in its strange position,” the company said.

In April, Gravity Defyer filed a lawsuit of its own against the FTC. Much of it hinges on a small 2017 study that the company has long used to justify its pain-relieving claims. The study, recently published the Journal of the American Podiatric Association, found that Gravity Defyer’s “shock-absorbing sole” reduces knee pain an average of 85 percent, significantly better than traditional soles.

The FTC says the study has “substantial flaws” because of its small size (52 participants) and duration (5 weeks), and because it relied on participants’ self-reported pain levels.

“It was also only designed to measure knee pain. Thus, the study was not sufficient to determine the effects of wearing Gravity Defyer’s footwear on knee, back, ankle or foot pain, or pain associated with the specific conditions claimed,” the FTC said.

The Commission, which voted 4-0 to file the complaint, is seeking an order permanently barring Gravity Defyer and Elnekaveh from making misleading or deceptive pain-relief claims, as well as civil penalties.

Injectable Gel Shows Promise as Treatment for Back Pain

By Pat Anson, PNN Editor

An experimental gel shows promise as a treatment for low back pain caused by degenerative disc disease (DDD), according to the results of a small study being presented at the annual meeting of the Society of Interventional Radiology in Boston.

Hydrogels have been used for years to treat DDD, but this is the first time that Hydrafil – an injectable gel developed by ReGelTec – has been tested on humans.

Hydrafil was injected into the discs of 20 people in Colombia with chronic DDD, who had average pain levels of 7.1 on a 10-point pain scale. None of the participants had found more than temporary, mild relief from treatments such as rest, analgesics, physical therapy and back braces.

“We really have no good treatments for degenerative disc disease, aside from conservative care,” said lead investigator Douglas Beall, MD, a medical advisor to ReGelTec and chief of radiology services at Clinical Radiology of Oklahoma.

“Surgery is statistically no more effective than conservative care and can potentially make things worse; nerve ablation is appropriate for only a few patients; and existing hydrogels are inserted through an incision as a soft solid, which can pop out of place if you’re not highly skilled in placing it.”

Because Hydrafil is injectable, it requires no incision and is minimally invasive, although patients are sedated for the procedure. Researchers heat the gel to become a thick liquid and then use a 17-gauge needle to inject it directly into the affected discs, using fluoroscopic imaging to guide them. The gel fills in cracks and tears in the disc, and then hardens, restoring the disc’s structural integrity. The procedure takes about 30 minutes.

This promotional video by ReGelTec demonstrates how Hydrafil works:

Six months after the injection, all 20 participants in the study reported significantly less low back pain, with their pain levels declining to an average of 2.0 on the 10-point pain scale. They also reported significantly better physical function.

“If these findings are confirmed in further research, this procedure may be a very promising treatment for chronic low back pain in those who’ve found insufficient relief from conservative care,” said Beall. “The gel is easy to administer, requires no open surgery, and is an easy procedure for the patient.”

In 2020, Hydrafil received the FDA’s breakthrough device designation, which allows for an expedited review of an experimental product when there is evidence it provides more effective treatment than current options.

ReGelTec is currently recruiting 50 people with DDD in Canada for a new clinical trial of Hydrafil.

Degenerative disc disease is one of the leading causes of chronic low back pain. Healthy discs cushion the spine’s vertebrae, facilitating movement and flexibility. But with activity and normal aging, discs can wear out and cause the bones of the spine to rub together and pinch nerves, causing pain and numbness. By age 60, most people have at least some disc degeneration in their spines.

Why Intractable Pain Treatment Requires a Stimulant

By Dr. Forest Tennant, PNN Columnist

In 1896, Dr. Henry Snow was the chief cancer surgeon at the Royal Brompton Hospital in London. He recognized and agonized over the immense pain and suffering of his patients when they developed constant pain and approached their end of life.

Dr. Snow wanted to relieve their suffering, so he administered the drugs that were available one at a time: morphine, cocaine and alcohol. With each he managed to get some pain relief, but didn’t obtain the relief he wanted and patients were still suffering. Not to be deterred, he made a profound discovery.

Dr. Snow mixed morphine and cocaine in liquid alcohol and administered the solution to his patients. Then he found formidable and humane pain relief. This three-drug mixture gave rise to the concept of “synergy of constituents,” which means that the simultaneous administration of multiple pain-relieving drugs added up to more than each one alone. In other words, two and two equaled six rather than four. 

The success of Dr. Snow’s discovery spread rapidly to other hospitals and countries, and became known as the “Brompton cocktail.” In France and elsewhere, physicians discovered they could add an antihistamine, antipsychotic or cannabis oil to the mixture and get even more pain relief.  

The Brompton cocktail was used until the 1970’s, when it gave way to the convenience of opioid tablets, capsules and injections, rather than the time and cost of making a liquid that contained multiple drugs. 

The Amphetamine Discovery 

Fortunately, after the demise of the Brompton cocktail, a handful of researchers weren’t about to forget the “synergy of constituents” and the pain-relieving potency of stimulants like cocaine. An example of the pain-relieving capability of stimulants is caffeine, which in the 1960’s was added to a variety of pain relievers such as aspirin and codeine to obtain synergy. 

Amphetamine was discovered in the 1930’s and promoted as “Benzedrine” to stay awake while driving. Because amphetamine produced alertness, it became known as a stimulant. Clinical reports began to surface in the 1940’s that amphetamine and its derivatives also helped depression, weight loss, mental alertness, hyperactivity and attention span. They soon began to be marketed and labeled for those conditions.  

Clinical studies on amphetamine derivatives for pain relief were finally started in the 1980’s, and they clearly showed that they provided a great deal of pain relief.  

By the time the last century folded, a core of pain researchers knew that not only cocaine but amphetamine derivatives such as methylphenidate and phentermine relieved pain. What they didn’t know was why. This answer was to come 15-20 years later. 

Stimulants Initially Rejected 

I became quite excited about the clinical trials that showed stimulants relieved pain, and in the late 1990’s gave a group of intractable pain patients the weak stimulant and weight loss drug phentermine, in combination with clonidine. The opioid dosages for these patients dropped 40 to 50 percent within six weeks and they got even better pain relief.

I presented my findings to colleagues at some national professional meetings. Much to my surprise, I was summarily informed that the new long-acting opioid formulations of the fentanyl patch (Duragesic), oxycodone (Oxycontin), morphine (MS Contin) and the implanted intrathecal (spine) opioid pump eliminated any need for stimulants or the concept of “synergy of constituents.”

By the turn of the century, the use of these new long-acting opioids and implanted opioid pumps became the standard of the day. Stimulants and their synergy were essentially forgotten, and they were rarely used for intractable pain again until about 2010. 

The Rebirth of Synergy 

After the year 2000, I don’t recall ever being referred an intractable pain patient who had not already been started on one of the long-acting opioids and/or an implanted opioid pump. They were referred to me simply because they were not getting adequate pain relief. Almost every one of these patients had found that their opioids quit working well, regardless of dosage or even if a second or third opioid was added to the mix.  

Somewhat out of desperation, about 12 years ago I recalled Dr. Snow, the Brompton cocktail and the “synergy of constituents.” I also remembered my study on phentermine and clonidine, so I started giving patients on opioids who were doing poorly my favorite stimulant, phentermine, or occasionally methylphenidate (Ritalin).  

Later the narcolepsy drug modafinil (Provigil) and a mixture of amphetamine salts (Adderall), came on the market. They too proved to be excellent “synergists” with opioids. I found that every intractable pain patient who received one of these stimulants not only got better pain relief and were either able to “hold the line” or reduce their opioid dosage.  

Phentermine continued to be my favorite stimulant to relieve pain and reduce the use of opioids because it additionally kept weight down and helped the patient keep moving and functional. 

Why Stimulants Work 

Although stimulants have been clinically known to relieve pain since Dr. Snow’s experiments in 1896, researchers didn’t provide us with the biologic “why” until recently. 

In the past decade, some outstanding researchers determined that there are about half a dozen different neurotransmitters in the brain and spinal cord that relieve pain. The three major neurotransmitters are endorphin, dopamine and gamma amino butyric acid (GABA). These neurotransmitters relieve pain by activating trigger points in the central nervous system called receptors. 

These astute researchers also determined that intractable pain may deplete endorphin, dopamine and GABA. Consequently, a substitute drug may have to be administered to obtain adequate pain relief.  

If you have constant, intractable pain, you may likely need the “synergy of constituents,” which will include an opioid, stimulant, and GABA substitute. Popular GABA substitutes include diazepam (Valium), carisoprodol (Soma), pregabalin (Lyrica), gabapentin (Neurontin), clonazepam (Klonopin), topiramate (Topomax) and alcohol. 

Which Patients Should Receive a Stimulant?

Stimulants have well-known abuse and addiction potential, so they should only be given to patients who have a well-documented disease or injury that is known to cause severe intractable pain. The most common diseases in this category are adhesive arachnoiditis, stroke or head trauma, reflex sympathetic dystrophy (RSD/CRPS), Ehlers-Danlos syndrome, and some autoimmune-collagen disorders.  

In most cases, patients who need a stimulant are clearly debilitated and require some family and caretaker support to function and carry out activities of daily living.  

Intractable pain patients have several dopamine substitutes available: 

• Amphetamine Salts (Adderall)

• Methylphenidate (Ritalin)

• Dextroamphetamine

• Phentermine

• Phendimetrazine

Misunderstood Objections

Many medical practitioners are not yet aware of the new research on stimulants and hesitate to prescribe them, even to needy, legitimate patients. The fear of abuse, diversion or dependence by the intractable pain or palliative care patient, while understandable, should not cause reluctance to prescribe a stimulant to these patients. No intractable pain patient will give away something that works so well.

In addition, the dosage of stimulants for pain relief is considerably lower than the usual level needed for abuse. Only small dosages are clinically needed in most cases and pharmacies today only issue limited quantities. Another safety factor in controlling adverse consequences of stimulants is that the severe intractable pain patient will usually have close family or caretaker support who can safely store and administer stimulants.

There is an unfounded fear of hypertension if a stimulant is prescribed. This is rarely the case, since the pain patient is dopamine deficient. A stimulant drug in an intractable pain patient may actually lower blood pressure since it may be elevated due to pain.

There is the belief that Adderall, Ritalin and some other stimulants are only for attention deficit hyperactivity disorder (ADHD). What is misunderstood is that ADHD is universal among intractable pain patients. Every person with intractable pain has reduced attention span, hypertension and agitation. One could argue that every intractable pain patient should be on a stimulant just for their ADHD. 

Dr. Snow and the Royal Brompton Hospital had the right idea. The severe, intractable pain patient needs an opioid to replace endorphin, a stimulant to replace dopamine, and a substitute for GABA.  

It’s time we bring back the “synergy of constituents” to humanely get better pain relief and simultaneously lower opioid dosages in the intractable pain patient. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his studies on the treatment of intractable pain through the Arachnoiditis Research and Education Project. A bibliography on stimulants for intractable pain treatment can be found here  

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

Virtual Reality Shows Long Term Benefits for Chronic Low Back Pain

By Pat Anson, PNN Editor

Critics of virtual reality therapy often say it’s a poor treatment for chronic pain because it only distracts patients from their pain and that the effects are temporary, at best.

But new research suggests that the benefits of virtual reality (VR) can last six months after treatment has stopped – at least for patients with chronic low back pain.

The study, published in the Journal of Medical Internet Research, followed 188 people with chronic low back pain who had an average pain intensity score of 5 on a zero to 10 point scale.

Half the participants were given an EaseVRx headset to watch 3-D programs daily for 8 weeks, immersing themselves in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery. The goal is help patients learn how to manage pain through cognitive behavioral therapy.  

The other patients also used the EaseVRx headset, but only watched routine nature scenes as a placebo or sham VR treatment.  

JOURNAL OF MEDICAL INTERNET RESEARCH

Patients were followed for six months after treatment was stopped. Participants in both groups reported improvement in their pain and other symptoms six months after treatment, but the improvements were more significant in those who received VR therapy. Pain intensity was 31% lower for patients in the VR group, compared to 16% in the sham group. Physical function, mood, sleep and pain-related interference in activity were also better in those who received VR therapy. No adverse side effects were reported in either group.

“We have been pleasantly pleased and surprised that patients are maintaining clinically meaningful changes in pain intensity and interference 6 months after returning the device. It appears people are actually acquiring skills in a relatively short period that they continue to retain/apply months after treatment,” said Josh Sackman, co-founder and president of AppliedVR, which makes the EaseVRx headset.

AppliedVR is planning more research to see how patients respond long-term to VR treatment. A brain imaging study is being conducted to measure brain activity before, during and after treatment. Patients are also being recruited for a large clinical trial to see how VR therapy impacts pharmacy and medical claims.  

“In order to drive real acceptance, we are committed to extensive research to address any skepticism people may have,” Sackman told PNN.

The EaseVRx headset was given a Breakthrough Device Designation by the FDA in 2020 for fibromyalgia and low back pain. Last year the agency authorized the marketing of the headset for chronic low back pain in adults, the first medical device of its kind to receive that designation.

EaseVRx headsets are currently being used for pain management in over 200 hospitals and healthcare systems. A full commercial launch for home-based use is not expected until next year.

Experimental Ketamine Pill Effective in Treating Acute Pain

By Pat Anson, PNN Editor

An experimental oral tablet that combines ketamine with aspirin was nearly as effective as an opioid in treating acute pain in emergency room patients, according to the results of a small pilot study.

Ketamine is a non-opioid analgesic that is also used to treat anxiety and depression. The drug is so potent, that it is usually administered by an infusion, injection or nasal spray under strict medical supervision. Some doctors and patients have also found ketamine effective as a treatment for certain chronic pain conditions.

“Ketamine has long been viewed as a highly promising analgesic, but its adverse effect profile, available routes of administration, and short-lasting effects limited its use. Our goal is to overcome all three of these limitations,” says Joseph Habboushe, MD, an emergency room physician and founder of Vitalis Analgesics.

Vitalis has developed a proprietary formulation of aspirin that delivers faster and stronger pain relief than traditional aspirin. The company is working to see if a combination of its aspirin with low-dose ketamine could be used to treat pain.

In the pilot study at Maimonides Medical Center in New York, 25 emergency room patients with acute musculoskeletal pain were given the ketamine-aspirin pill – called VTS-85. After an hour, their pain level scores were reduced an average of 3.8 points, pain relief similar to that of oxycodone-acetaminophen (Percocet) formulations, which reduced pain levels by 4.0 points in previous studies.

Researchers say the pain relief from VTS-85 lasted for two hours, with pain scores dropping an average of 4.4 points. Notably, only 4-8% of patients experienced the dissociation and sedation that is usually experienced when ketamine is administered intravenously.

“The results of this pilot study are highly encouraging, with pain reduction similar to studies using IV ketamine formulations but lasting longer and with lower side effects, and it’s oral,” said Habboushe.

The study findings are published in The Journal of Emergency Medicine.

“If proven in larger controlled trials, this could represent a breakthrough in the treatment of acute pain and a range of other indications,” said lead investigator Sergey Motov, MD, Department of Emergency Medicine, Maimonides Medical Center.

Vitalis has completed a second larger trial on the use of VTS-85 in emergency room patients, but the results have not yet been released. The company is also studying VTS-85 as a treatment for acute headache and postoperative pain. The ketamine-aspirin pill will require a prescription if approved by the FDA.