Learning Mindfulness and a Positive Attitude

By Barby Ingle, Columnist

Mental health can be disrupted when living with chronic pain. Anxiety, depression, isolation, and feelings of hopelessness and helplessness can increase to dangerous levels. Life can become overwhelming -- particularly for people who have been suffering with chronic pain for a long period of time. The idea of living with this horrible disease with no cure is astounding.

When my chronic pain started doctors often told me, “Just do this and you will be okay.” I would build up my hopes and follow their directions. But when I did not get better, I came crashing down and so did life around me.

When I finally realized there was no cure for my chronic pain and that my future would include pain on a daily basis, I began to have dark thoughts. I went through a grieving process in the course of coming to grips with my new reality. It is hard for many pain sufferers to accept their changing life, and the loss of independence and function.

It is very important for you and your family to recognize the symptoms of diminished emotional well-being and take action or you may end up at risk of suicide. There are going to be good and bad days, and if this is a bad day for you, remember to focus on the good days, good feelings and positive past and future experiences.

It was when I began looking for solutions, and displayed a positive attitude, self-esteem and confidence, that I began to attract other people who wanted to help me accomplish my needs and goals. Be sure to surround yourself with a team that is on your side, or you will be in a fight in which you will have trouble winning.

Creating a positive attitude starts with being inspired. You can begin by finding new interests and hobbies you can enjoy. A few suggestions are joining a non-profit cause, solving puzzles, writing a journal, joining or starting a support group, or even starting a blog. Creating a purpose can assist with your self-esteem and confidence.

I have learned that every person has a value no matter how big or small they seem. Believing in yourself and in your abilities, choosing happiness and thinking creatively is good motivation when it comes to accomplishing your goals. Learn to expect success when you are going through your daily activities. It might take you longer or you may need to use more constructive thinking to achieve success, but it is possible. 

There are great benefits to having a positive attitude, especially when things are not going your way. Staying optimistic will give you more energy, happiness and lower your pain levels. Success is achieved faster and more easily through positive thinking, and it will inspire and motivate you and others. I have found that when I am letting the pain get the better of me, it comes across to others as disrespect and brings those around me down.

No matter the challenges of today, they will pass, and will not seem as bad as time moves on. Challenges often turn out to be a bump that looked like a mountain at the time. You can be mentally positive and happy even when there are large obstacles to overcome.

No person or thing can make you happy and positive. Choosing to be happy starts with mindfulness.  

You can learn about mindfulness and moving beyond psychological suffering in a free two-part webinar I’ll be hosting, featuring Dr. Melissa Geraghty on April 28 and Dr. Karen Cassiday on May 13.  You can register for the webinars and learn more about treatments for anxiety and depression by clicking here.

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation (iPain). She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

The Advantages of Having a Service Dog

By Ellen Lenox Smith, Columnist

I chose to apply for a service dog after meeting someone else with Ehlers Danlos syndrome (EDS) who had been given one by the National Education for Assistance Dog Services (NEADS), also known as Dogs for Deaf and Disabled Americans.

At first, I was nervous that I would not be able to handle the responsibility, afford the cost, and that I would not qualify for a service dog. But the decision to apply and later bring “Maggie” into our lives was one of the best I’ve ever made.

Six days after coming home from a two week training program, Maggie saved my life. To this day, she senses when I have my breathing cut off and alerts me.

Maggie can somehow tell in the morning that I am headed for a bad night. She will look me in the eyes, nudge against me, lick my legs and not leave me alone. She was not trained to know this, but we somehow bonded so well in the first few weeks that she can sense when my oxygen levels are too low.

At night when she senses this, Maggie wakes me -- first by pacing on the bed, then whining, and if that does not work, she licks or nudges me until I awake.

I met Maggie when I was barely able to walk. She quickly helped me learn to live life in a wheelchair.

Imagine what it is like to drop an object and not be able to get down and pick it up. Maggie will pick up whatever she finds on the ground and bring it to me. She can retrieve the phone and pick up paper, pens, and almost any size object. She can even be sound asleep and hear me drop something and come right over to get it for me.

I also find her support with balance. Although NEADS does not train dogs to wear harnesses for balance, they do help you to utilize the dog for simple tasks, like getting up safely from a chair, out of a car and even off the toilet seat.

Maggie provides amazing pain relief and comfort, too. The heat from her body when she spoons against me, provides soothing comfort that goes way beyond any medication. To have her by my side helps me to gain confidence with my constantly slipping body.

I am always loved, cared for and never alone. As a service dog, Maggie can be by my side wherever I go -- whether it is the hospital, airport, train, pool, store, car, hotel, restaurant, and even the White House. She is welcome all places except a military base or private home. Those are the only places I must get permission for her to be with me.

Caring for Your Service Dog

I was concerned that I would not be able to care for my dog. But NEADS will train you to learn how to take care of the dog you are matched with no matter what your physical challenges might me. Do not stress about that - they will guide you and your dog through the process.

You will be taught how to care for the dog, how to feed, groom and exercise them, despite your obstacles.

Can You Afford a Service Dog?

An average NEADS dog costs over $42,000, but they only ask clients to raise a minimum of $8,000. I was so concerned I would never be able to raise the money for my dog, but NEADS put my mind at ease, explaining that they set up an online fundraising page for you to send out that tells your story and asks for support.

I sent the link to friends and also posted the story in local stores. In three months, all the money for Maggie was donated by people, many of whom I didn’t even know. Do not stress about the cost. NEADS will work that out if you qualify for a dog. They just ask that you help them defer the cost.

To apply for a dog, go to the NEADS website, fill out the application and then expect a call for an interview. Always feel free to contact their office to be sure the request has come through and to get an update on the status of your application.

I always encourage those that are considering a service dog to go ahead and apply, even if they have reservations, to get on the waiting list. The worst that can happen if you change your mind is that someone else gets the dog selected for you.

The wait can take from a few weeks to up to a year and a half. So why not get in line?

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis. Ellen and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition.

For more information about medical marijuana, visit their website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Study Finds Meditation Effective for Low Back Pain

By Pat Anson, Editor

A form of meditation called mindfulness-based-stress-reduction is more effective in treating chronic low back pain than the “usual care” provided to patients, according to a new study published in JAMA. The study also found that cognitive behavioral therapy also lessened pain and improved function better than standard treatments for patients with low back pain.

Mindfulness-based stress reduction (MBSR) is a mind-body approach that focuses on increasing awareness and acceptance of moment-to-moment experiences, including physical discomfort and difficult emotions. Although MBSR is becoming more popular, few studies have been done on its effectiveness in treating low back pain.

Cognitive behavioral therapy (CBT) is a form of psychotherapy, in which a therapist works with a patient to reduce unhelpful thinking and behavior.

Researchers in Washington state enrolled 342 people in the study with chronic low back pain and divided them into three groups that received yoga, training and treatment with MSBR, CBT or usual care.

After 26 weeks, 61% of the patients in the MSBR group reported clinically meaningful improvement in function, compared to 58% in the CBT group and 44% of those who received usual care. Similar results were also found in pain relief.  

Participants in the MSBR and CBT groups also reported less depression and anxiety than the usual care group. 

The researchers said the results were “remarkable” because nearly half of the patients enrolled in the MSBR and CBT groups skipped several of the group sessions they were assigned to.

“In a time when opioid prescribing is on the decline I would think this would be exciting and welcome news for those of us who suffer severe, chronic pain,” said Fred Kaeser, who battled severe back pain for many years, and eventually found relief through a combination of meditation, exercise and changes in diet.

“Very encouraging to think that we are getting very close to being able to say that MBSR and CBT are empirically valid, pain-reducing, complimentary therapies to whatever medical care one might usually receive for the mitigation of pain.  The thought that one might also be able to reduce one's intake of pain medications and possibly other intrusive pain interventions by engaging in a therapy that is extremely safe with no side-effects is exceptionally encouraging,” Kaiser wrote in an email to Pain News Network.

“Hopefully, people who have previously dismissed the idea of mindfulness meditation or CBT as a valid pain reducing strategy will re-think their position and give these, as well as other promising complimentary pain reducing modalities, a try.”

Recent studies by researchers at Wake Forest University found that mindfulness meditation appears to activate parts of the brain associated with pain control.

Lower back pain is the world’s leading cause of disability. About 80 percent of adults experience low back pain at some point in their lives.

A Migraine Sufferer Finds Hope Again

By Paul Hannah, Guest Columnist

On a Sunday morning 33 years ago, I was reading a newspaper in bed and was suddenly struck with a headache. I hadn't really had many headaches before, so I expected that this would pass with some non-prescription medication and an hour or so in bed.

I was very wrong.

I still have that headache today. If it would have stayed at a 1/10 pain level, I probably would not have done much about it. However, it didn't stay that low and that was where the problem lies.

When the headache moves to 4/10 or 5/10 I get concerned, because if I don't stop it at that point, it will rapidly scale up to a full migraine.

I have read other accounts of migraines, but very few accord with mine. My neck gets stiff, the trapezius muscles lock up, and my eyes start to hurt. I become rapidly photophobic and the pain gathers and localizes in the frontal lobe of my brain.

Once it reaches 6/10, I get a syringe from my migraine drawer and inject Maxolon into my arm muscle and immediately lie down. As a result of the photophobia, I have built myself a four poster bed so that I can draw the curtains and be in total darkness. After the Maxolon kicks in, I drink some liquids, often very strong coffee, and take as many of the various painkillers as I dare.

PAUL HANNAH

About fifty percent of the time, that is enough and spending the next five or ten hours in bed gets me well enough to function again. The other fifty percent of the time, it gets worse. Much worse.

It feels like someone is reaching into my skull and squeezing the frontal lobe of my brain with each beat of my heart. At this point, it becomes imperative, as bizarre as it seems, for me to concentrate. This is because the pain momentarily stops when I sub-consciously hold my breath, and then when I do finally breathe, it gets worse.

These migraines happen so frequently and unpredictably that I have given up traveling. I joke and say that I have seen the inside of too many foreign hospitals - but it is no joke, I love traveling. I miss it terribly.

I have a sympathetic doctor who will write scripts for pethidine (Demerol) every six weeks. It took literally years of doctor shopping to find him. If I have any pethidine left, I give myself an injection. The wave of relief that passes through me with that drug is hard to describe. I heard an opium addict describe her relief like this: "The pain is still there, you can still feel its presence, but it doesn't hurt anymore." It is like that for me.

Every migraine sufferer I have discussed this with has resonated with three annoying things that people come up with. Some women (and it always has been women in my experience) place two fingers to their temples and say, "I have a migraine". Anyone that has ever experienced a 10/10 could no more speak and function as 'normally' as that, than fly. They simply have no idea how bad it is. Fingers are regarded as among the most sensitive to pain areas of the body and anyone hitting a thumb with a hammer can attest.

Eighteen months ago I had an accident in my workshop and cut off my left index finger, half of my thumb and mashed up the other fingers in that hand. The pain level was 5/10. I took the painkillers the paramedics offered, but I didn't need them. The painkillers I took in hospital were for my head, not my hand.

The second annoying thing is when we are asked, "Have you looked into the cause?" I am barely able to contain my sarcasm when confronted with this. I desperately want to say something like "Well goodness me! That IS a good idea, why didn't I think of this thirty years ago?" But I don't, I just look away and say something equally inane.

Just as annoying are those that have an aunt who was cured by giving up coffee (tried it for 9 months, no change), going through menopause (strangely enough, not all that helpful to me) or taken some homeopathic/natural or equally nonsense cure (One said a foot massage was sure to fix it).

I am fortunate in that I live in Australia, a place where universal free healthcare is considered a citizen's right and a government's responsibility. So I have had several MRIs, X-rays and even an EEG, nothing has ever shown up as anything but normal.

When Francis Collins finished the Human Genome Project I thought it was marvelous from a human achievement point of view, but nothing more. I had no idea that it was going to change my life. But change it, it did and in all the right ways.

When I heard about this from another genuine migraine sufferer I took a blood test and for the first time in 33 years I had a non-normal result. It seems there is a genetic mutation called MTHFR, and if a person has one of them, it makes it difficult to process vitamin B. I have two of the sods.

I have spent my life being deficient in Vitamin B2, all the while my blood was full of the stuff. Both of those conditions can cause migraines. For the last eight weeks I have been taking a number of supplments and a cream - DHEA/CHYSIN, zinc, B-2, 5-MTHF and D-3. So far, I have had nothing worse than a 4/10 headache and I have every reason to suspect that this improvement will continue.

The Human Genome Project has given me something I thought I would never have again: hope. And hope to the hopeless is a marvelous thing. Truly marvelous.

I urge every migraine sufferer who can afford it to take the test. This isn't foot massage or acupuncture nonsense, it might actually work.

Paul Hannah lives in a small town just north of Brisbane, Australia on a few acres of bush populated with wallabies, koalas and a wide variety of native birds. He is retired and enjoys writing, history, astronomy and woodwork. 

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Study May Explain How Meditation Relieves Pain

By Pat Anson, Editor

Some pain sufferers report success using cognitive behavioral therapy and mindfulness mediation to reduce their pain. But how those techniques work is a bit of mystery and has led to speculation that they have a placebo effect on pain.

But a new study by researchers at Wake Forest University suggests that meditation really does provide pain relief – but not by utilizing the body’s natural endogenous opioid system.

“Our finding was surprising and could be important for the millions of chronic pain sufferers who are seeking a fast-acting, non-opiate-based therapy to alleviate their pain,” said Fadel Zeidan, PhD, assistant professor of neurobiology and anatomy at Wake Forest Baptist Medical Center.

Zeidan and his colleagues enrolled 75 healthy, pain free volunteers in a study. Some were injected with naloxone, which blocks the pain reducing effects of opioids, while others were injected with a placebo saline solution.

Participants were then divided into four groups: meditation plus naloxone; no meditation plus naloxone; meditation plus placebo; or no meditation plus placebo.

Pain was induced in all four groups with a thermal probe that heated their skin to over 120 degrees Fahrenheit (49 degrees Centigrade), a level of heat that most people find very painful.

The group that meditated and was injected with naloxone had a 24 percent reduction in their pain ratings, showing that even when the body’s opioid receptors were chemically blocked, meditation still was able to significantly reduce pain. Pain ratings were also reduced by 21 percent in the meditation group that received the placebo injection.

By comparison, the two control groups that did not meditate  reported increases in pain regardless of whether they got the naloxone or placebo-saline injection.

“Our team has demonstrated across four separate studies that meditation, after a short training period, can reduce experimentally induced pain,” said Zeidan. “And now this study shows that meditation doesn’t work through the body’s opioid system.

“This study adds to the growing body of evidence that something unique is happening with how meditation reduces pain. These findings are especially significant to those who have built up a tolerance to opiate-based drugs and are looking for a non-addictive way to reduce their pain.”

The next step for researchers is to determine how mindfulness meditation can affect a spectrum of chronic pain conditions.

“At the very least, we believe that meditation could be used in conjunction with other traditional drug therapies to enhance pain relief without it producing the addictive side effects and other consequences that may arise from opiate drugs,” Zeidan said.

An earlier study by Zeidan found that mindfulness meditation activates parts of the brain (orbitofrontal and anterior cingulate cortex) associated with pain control, while it deactivated another brain region (the thalamus) that regulates sensory information. By deactivating the thalamus, meditation may cause signals about pain to simply fade away.

In addition to relieving pain, there is increasing evidence that mindfulness meditation is effective in treating a broad range of mental health issues, including anxiety, depression and stress. One study, published in the British Medical Journal, found that online mindfulness courses were often just as effective as face-to-face meetings with a therapist.

You can sample a relaxing online pain management meditation at Meditainment.com (click here to see it). The initial course is free.

Pain Companion: Talking About Pain

By Sarah Anne Shockley, Columnist

A lot of us don’t like to talk about our pain, understandably. It often seems easier just to live with it in silence than to discuss it with anyone. Ever.

If others have never experienced long-term pain or are pain-avoidant, it can be nearly impossible for them to understand what we’re talking about. We may be answered with blank stares or outright disbelief.

Or, what often happens is that others feel they must try to fix us. We are offered all kinds of medical advice, given the business card of a favorite massage therapist, or web address for the latest miracle supplement. Or we’re told exactly what we don't need to hear: buck up, carry on, be more positive, grin and bear it. Fending off the well-meaning fixers can be exhausting, so we just keep quiet.

And, when we do talk honestly and openly about our pain, sometimes it feels like we’re walking right into the center of it. We become very present to it, and if it also feels like we’re not really heard or validated, we’ve added another level of emotional pain and disappointment to our physical pain. So why bother?

These are all perfectly understandable reasons for not talking about pain.

So why would we talk about it?

Because the alternative - never fully expressing to anyone what we are going through at the deepest levels - is much harder in the long run.  As you probably know quite well, living with pain can be extremely isolating. We are alone in our unique and deeply intimate experience of pain.

While we have very good reasons not to talk about our pain with everyone, if we never talk about it we can feel increasingly disconnected from others, from life, and from ourselves. And I know from personal experience that this can be a very difficult way to live.

For eight years, the only person who understood the full extent of the pain I was in was my neurologist. For all of the reasons listed above, I simply never told anyone else how bad it really was. And I can say at this point that living with pain doesn't get easier and life doesn’t get better by not talking about it. That choice only increases the feelings of invisibility, isolation, and disconnection.

However, talking openly about pain is a tricky business. Finding someone who can be with us and just listen is challenging because so many think they are being helpful by trying to distract us from our pain, or help us overcome, avoid, or downplay it.

People are so geared toward ending pain that they are not always prepared to just be with us and be a compassionate witness. And some people are living with their own unexpressed pain, whether physical or emotional, and they just don’t have the capacity to hear about ours.

So, I would not advocate talking about your pain to just anyone.  It requires a somewhat selective process. There are friends and family that you would like to be able to share with who will not be willing or able. Think about the people in your life that you consider good listeners and who you can trust to truly have your best interests at heart.

Even if there is no one you know who has experienced physical pain in the way that you have, there will most likely be someone who has experienced a deep loss or had to face very trying circumstances that will give them a deeper sense of compassion for what you are going through. They may have been dealing with their own private pains and you may be surprised to find out that they understand about hiding, isolation and loneliness. If you feel there is no one like that in your life, then a trained therapist can be a good choice.

Once you’ve ascertained that this person is an appropriate choice and they are agreeable, then help them understand that what you need is a pair of receptive ears and a receptive heart, and that talking about your pain won’t make it worse, but will actually help you.

Tell them that what you are going to share may be difficult for them to hear, but that you really need them to just be there and hear it without offering anything back for now. Ask them to please hear you out without trying to change anything, fix anything, offer advice, or console you.

Before you have your talk, see if they are willing to agree to the following ground rules:

• Listen to your story without interrupting
• Be present with you in your pain without pity and without fixing
• To not offer advice, just witness

Let them know that the most supportive thing they can do for you right now is not to try to make it all better or make it all go away, but to just be present with you and let you have your pain and not try to change anything for now.

You may want to tell several people, but you may also find that one trusted person who can see you, hear you, and be with you in it is enough. Then, of course, express your gratitude in whatever way you feel is appropriate and let them know what a great gift they have given to you.

And, perhaps when you are done telling your story to this person, on another day, you can offer receptive ears and a receptive heart to them.

Sarah Anne Shockley suffers from Thoracic Outlet Syndrome, a painful condition that affects the nerves and arteries in the upper chest. Sarah is the author of The Pain Companion: Everyday Wisdom for Living With and Moving Beyond Chronic Pain.

 Sarah also writes for her blog, The Pain Companion.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Plasma Therapy Helps Rotator Cuff Injuries Heal

By Pat Anson, Editor

Kobe Bryant, Peyton Manning and Alex Rodriguez have used it to treat chronic injuries and extend their athletic careers. But does platelet-rich plasma therapy (PRP) work for amateur athletes and weekend warriors?

According to a small pilot study published in PLOS ONE, a single PRP injection helps reduce pain and heal injured tissue.in patients with chronically sore shoulders caused by rotator cuff tears. 

"We studied patients 35 to 60 years old with rotator cuff tendinopathy due to normal aging. For the first time, we were able to not only find reported improvements in pain and mobility, but also in the tissue - the MRI before and after showed structural change and a decrease in the size of tears," says lead author Marni Wesner, sports medicine physician at the University of Alberta’s Glen Sather Sports Medicine Clinic.

PRP therapy is an emerging therapeutic procedure for the treatment of both acute and chronic soft tissue injuries. The procedure involves withdrawing blood from the patient and then spinning it to produce a high concentration of platelet cells. The plasma is then injected back into the patient at the injury site, speeding up the natural healing process.

The pilot study involved only a small number of participants – 7 patients with rotator cuff tendinopathy received a PRP injection and 2 received a placebo injection. All participants then took part in a 3-month home-based daily exercise program.

"Based on MRI findings before and after the injections, we saw improvements in the tissue six months later in five of seven patients undergoing PRP and an appropriate rehabilitation program. The healing in the tissue appeared to correspond with the reported improvement of the pain and also with the clinical assessment of function," explains Doug Gross, interim chair of physical therapy at the Faculty of Rehabilitation Medicine.

One of the patients who benefitted from the treatment was Debbie Brown, a retired police officer.

"For the past two years, I have tried everything for my right shoulder. Physio would help for a bit but then the problem would still be there. I tried acupuncture, Kinesio tape, cortisol injections - you name it, I've tried it," says Brown. "Once I did the PRP, it really did fix everything!"

At age 58, Brown says her injured shoulder feels like new.

"I can shoulder-check now and brush my hair. I can work out and be active again," she says.

Researchers admit the small size of the study and other factors may have affected the results.

“Patients considered for this study had very high expectations of PRP treatment, with 70% willing to pay out-of-pocket for the therapy to avoid the possibility of receiving a placebo injection. This presented a serious challenge for recruitment and will likely limit the ability of future investigators to enroll sufficiently large and representative samples of patients for PRP trials. High patient expectations and the placebo effect on clinical outcomes also cannot be discounted,” said Wesner.

In fact, one of the patients who received placebo treatment reported improvements in both pain and physical function – which could have been a placebo response to the injection or because of the home exercise program they participated in.

Los Angeles Lakers star Kobe Bryant was one of the first professional athletes to receive PRP therapy, traveling to Düsseldorf, Germany for a more refined version known as the Regenokine treatment.  Peyton Manning, Alex Rodriquez, Vijay Singh and other professional athletes soon followed.

Only a few small clinical trials have been conducted on the effectiveness of PRP therapy. Patients with knee osteoarthritis showed significant improvements as long as two years after PRP injections, according to a study published in The Journal of the American Osteopathic Association.

Vitamin D Ineffective for Knee Osteoarthritis

By Pat Anson, Editor

Recent studies have suggested that Vitamin D supplements may help reduce pain from fibromyalgia, arthritis and other chronic conditions.

But the “sunshine vitamin” did not relieve pain or stop cartilage loss in patients with knee osteoarthritis, according to new research published in JAMA.

Osteoarthritis is a joint disorder that leads to thinning of cartilage and progressive joint damage. Knee osteoarthritis (OA) is very common and affects over 250 million people worldwide. Nearly 40 percent of Americans over the age of 45 have some degree of knee OA.

Over 400 people with knee OA and low serum levels of Vitamin D participated in the placebo controlled study in Australia and Tasmania. They were divided into two groups; with one receiving Vitamin D supplements and the other a placebo.

Over the course of the two-year study, knee pain, stiffness and physical function were measured with the WOMAC pain scale and MRI scans were used to monitor cartilage volume, defects and bone marrow lesions.  

While the supplements did increase Vitamin D blood levels, they did not reduce knee pain. MRI’s also showed no significant differences in cartilage between the two groups.

“Vitamin D supplementation, when compared with placebo, did not result in significant differences in change in MRI-measured tibial cartilage volume or change in WOMAC knee pain score over 2 years. These findings do not support the use of vitamin D supplementation for preventing tibial cartilage loss or improving WOMAC knee pain among patients with knee osteoarthritis,” said lead author Changhai Ding, MD, of the University of Tasmania.

Vitamin D helps control levels of calcium and phosphate in the body and is essential for the formation of strong bones and teeth. Vitamin D also modulates cell growth, improves neuromuscular and immune function, and reduces inflammation

Vitamin D deficiency – a condition known as hypovitaminosis D -- is caused by poor nutritional intake of Vitamin D, inadequate sunlight or conditions that limit Vitamin D absorption. The most severe type of hypovitaminosis D causes general body pain, especially in the shoulder, rib cage, lumbar and pelvic regions.

Researchers at National Taiwan University Hospital recently found a “positive crude association” between fibromyalgia and hypovitaminosis D.  According to the Vitamin D Council, low levels of Vitamin D could be the result of fibromyalgia, rather than the cause of the disease.

Sources of Vitamin D include oily fish and eggs, but it can be difficult to get enough through diet alone. Ultraviolet rays in sunlight are the principal source of Vitamin D for most people.

Spider Venom Could Take Sting out of Chronic Pain

By Pat Anson, Editor

Researchers in Australia have isolated a toxin in the venom of a tarantula that shows promise as a pain reliever. The discovery could accelerate development of a new class of natural painkillers that are not addictive and more effective than opioids.

Thrixopelma pruriens, more commonly known as the Peruvian Green Velvet Tarantula, is native to South America.  The spider’s bite isn’t potent enough to kill humans, but researchers at the University of Queensland say its venom inhibits pain receptors.

"Our group is specifically interested in understanding the mode of action of this toxin to gain information that can guide us in the design and optimization of novel pain therapeutics," said Sónia Troeira Henriques, senior research officer at the University of Queensland's Institute for Molecular Bioscience.

The peptide toxin – known as ProTx-II – inhibits pain signals by binding to the membranes of nerve cells.

image courtesy yale university

"Our results show that the cell membrane plays an important role in the ability of ProTx-II to inhibit the pain receptor. In particular, the neuronal cell membranes attract the peptide to the neurons, increase its concentration close to the pain receptors, and lock the peptide in the right orientation to maximize its interaction with the target," said Henriques.

Henriques and her colleagues were the first to discover the importance of membrane-binding properties of ProTx-II in inhibiting a human pain receptor known as Nav 1.7. Previous research has shown that people born without Nav 1.7 channels due to genetic mutation are indifferent to pain – so blocking those channels in people with normal pain pathways has the potential to “turn off” pain.

University of Queensland researchers have studied the venom of over 200 spider species and found that 40% of the venoms contain at least one compound that blocked Nav 1.7 channels. But they’ve only scratched the surface. There are over 45,000 species of spiders, many of which kill their prey with venom that contain hundreds - or even thousands - of protein molecules that block nerve activity.

Based on the group's findings, they're now designing new toxins with greater affinity for the cell membrane and fewer side effects.

"Our work creates an opportunity to explore the importance of the cell membrane in the activity of peptide toxins that target other voltage-gated ion channels involved in important disorders," said Henriques.

Researchers are also studying the potential of venom in cone snails for its potential for blocking pain signals in humans. German scientists at the Pharmaceutical Institute of the University of Bonn say one advantage of the peptides found in snail venom is that they decompose quickly and are unlikely to cause dependency.

A pharmaceutical drug derived from cone snail neurotoxins has already been developed and marketed under the brand name Prialt. The drug is injected in spinal cord fluid to treat severe pain caused by failed back surgery, injury, AIDS, and cancer.

Acupuncture Lessens Fibromyalgia Pain

By Pat Anson, Editor

Nine weekly sessions of individualized acupuncture significantly lessened pain intensity and improved function and quality of life in people with fibromyalgia, according to researchers in Spain. Their placebo controlled study, published in Acupuncture in Medicine, also found the beneficial effects of acupuncture often continued a year later.

Fibromyalgia is a poorly understood disorder characterized by deep tissue pain, headaches, fatigue, depression and insomnia. It affects about one in 20 people.  The cause is unknown and there is no cure.

About 90% of people who have fibromyalgia try some form of alternative therapy such as massage, hydrotherapy, and acupuncture. But most of the data on the effectiveness of acupuncture have been based on clinical trials of standard, rather than individually tailored, treatment.

To find out if a more personalized approach would be more effective, researchers compared individually tailored acupuncture therapy with sham treatment in 153 adults, all of whom had been diagnosed with fibromyalgia, according to diagnostic criteria set out by the American College of Rheumatology.

Patients continued to take whatever drugs they had been prescribed to alleviate symptoms during the course of the study.

Both the real and simulated treatments were provided in nine weekly sessions, each lasting 20 minutes. Participants were asked about their perceived levels of pain, depression, and health related quality of life (physical and mental) before treatment began; and then again at 10 weeks, 6 months, and 12 months afterwards. The overall impact of their condition was measured by the Fibromyalgia Impact Questionnaire (FIQ).

After 10 weeks, perceived pain intensity was lower among those given real acupuncture. Their pain scores had dropped by an average of 41%, compared with an average of 27% for those given the placebo treatment. Significant differences persisted after a year, with an average fall of 20% in the pain score among those treated with acupuncture compared to about 6% for those given the simulated treatment.

Participants who were given the real treatment also had fewer tender points, and had less fatigue, anxiety and depression. FIQ scores also differed significantly between the two groups.

“Individualized acupuncture treatment in primary care in patients with fibromyalgia proved efficacious in terms of pain relief, compared with placebo treatment. The effect persisted at one year, and its side effects were mild and infrequent. Therefore, the use of individualized acupuncture in patients with fibromyalgia is recommended,” wrote lead author Dr. Jorge Vas, Doña Mercedes Primary Health Centre, in Dos Hermanas, Spain.

Acupuncture was originally developed as part of traditional Chinese medicine and is one of the most widely practiced forms of alternative medicine. As many as 3 million Americans receive acupuncture treatments, most often for relief of chronic pain. While there is little consensus in the medical community about acupuncture’s value, a large study in the Archives of Internal Medicine found that  “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option.”

How Going Gluten-Free Helps with Fibromyalgia

By Donna Gregory Burch, Columnist

I know some of you probably rolled your eyes when you read the headline of this story. I know that because I used to do the same thing.

Since being diagnosed with fibromyalgia, I've heard countless people talk about how going gluten-free improved their symptoms.

Whenever I'd hear that, I'd always think the same thing: "Fibro can be a living hell of pain and fatigue and everything else. I've already given up part of my life because of this horrible condition. You want me to give up donuts and cake and yeast rolls too? Are you kidding me? My sweet treats are one of the only things that make life bearable!"

But then my new fibromyalgia doctor ordered me to go on a strict anti-inflammatory, gluten-free diet. During the first two months of the diet, I allowed myself one "cheat" meal a week, which usually involved emptying out the complimentary bread basket at my favorite restaurant or shoving half of a pizza down my throat.

My doctor wasn't happy. He said I was just holding up my progress - that by reintroducing gluten every few days, my body didn't have the opportunity to properly cleanse and heal - and that I would never feel the full effects of the anti-inflammatory diet until I cut out gluten for good.

In my gut, I knew he was right. I'd paid good money for his expertise, and here I was not following his protocol. So, on Thanksgiving, I concluded my meal with a slice of pumpkin pie, and I've been gluten free ever since.

After three weeks of no gluten, my daily pain levels had decreased. I was having more low pain days than usual, with my levels falling between 1-3 on the pain scale.

And then I messed up.

I was really tired one night and didn't feel like cooking dinner. I asked my hubby if we could go out to eat at a new restaurant in town. It was the first time I'd dined out since becoming serious about going gluten free. I chose the salmon and veggies with a tarragon sauce. I thought I was making a good choice.

On the way home, I began having stomach cramps. I felt dizzy and nauseous. I knew I'd been exposed to gluten because I'd had these same gastrointestinal symptoms when I'd enjoyed my "cheat" meals previously.

The human body is so incredibly amazing to me. My doctor explained that when someone eats gluten every day, the body compensates as best it can. You may feel bloated or have acid reflux or feel extremely tired, but you'd never connect that to gluten exposure because it's just part of your day-to-day existence. But when you detox from gluten for several weeks, and then reintroduce it, the body will often react strongly to gluten if you have sensitivity to it.

My reaction to that gluten-laden meal reminded me of when I quit smoking years ago. I quit several times before I was finally successful. Sometimes I'd go days without a cigarette, and when I'd resume my bad habit, those first couple of cigarettes would make me sick-as-a-dog nauseous. I recognized that it was my body's way of telling me, "Stop it! I don't like what you're putting in me!"

And here I was, years later, with my body telling me again, "Stop it! I don't like when you eat gluten!"

As a gluten-free newbie, it took me a few minutes to realize the tarragon sauce on the salmon must have been thickened with flour. I figured I would go to bed with a queasy stomach, sleep it off and that would be the end of it.

But two hours after eating that meal, I started to feel a humming, vibrating pain come over my entire body. My arms, back, legs, hips - everything - ached. It was that same old achy fibro pain that I'd been living with on and off for years, and I was completely miserable.

For the first time, I connected what I ate to how I felt, and I was shocked. Logically, I know eating breads, cookies, pastas and other gluten-laden foods aren't good for me. They give me an energy boost, but then I crash, and I feel worse than before. I know they spike my blood sugar and that I shouldn't eat them because I have a family history of diabetes. I know they make me fat and lethargic.

But I didn't know they were increasing my pain. It was a wake-up call for me.

It turns out all of those fibromites who talk up the benefits of going gluten free might be right. Three small Spanish studies support anecdotal accounts from patients that gluten may increase fibromyalgia pain:

• A 2014 study involving 20 fibromyalgia patients who followed a gluten-free diet for 16 months found that "the level of widespread chronic pain improved dramatically for all patients; for 15 patients, chronic widespread pain was no longer present, indicating remission of fibromyalgia. Fifteen patients returned to work or normal life. In three patients who had been previously treated in pain units with opioids, these drugs were discontinued. Fatigue, gastrointestinal symptoms, migraine and depression also improved together with pain."
• A larger 2014 study involving 97 fibromyalgia patients with comorbid irritable bowel syndrome had a "slight but significant improvement in all symptoms" after following a gluten-free diet for one year. "Our findings suggest that further studies of this subject are warranted," reads the study.
• A 2013 study involving seven fibromyalgia patients with comorbid celiac disease found a gluten-free diet "can simultaneously improve celiac disease and irritable bowel disease/fibromyalgia symptoms, and indicate the merit of further research on a larger cohort."

Yes, I know these are small studies, and none of them are double-blind with control groups. But what if? What if giving up cupcakes could reduce your pain, even just by one-third or one-half? That could be life-changing for many of us with fibro!

I've had one other episode where I was accidentally "glutened" at a restaurant. As with the salmon, I again felt gastrointestinal symptoms on the way home, and again, my pain levels increased for a day or two afterwards. I don't think it was a coincidence.

I am a believer now in the benefits of going gluten free, and from here forward, I will be one of those annoying people on Facebook and in the online support groups who, when someone asks if anything helps with fibromyalgia symptoms, will chime in and say, "My pain is much better since going gluten-free."

No one wants to hear that, and I get it! Giving up gluten is really hard. It seems like it's in almost everything! And who wants to envision a life without birthday cake ... without a juicy hamburger on a bun ... without a slice of gooey cheese pizza ... without Grandma's homemade bread? I hate that my body has betrayed me like this - that it now identifies all of my favorite foods as the enemy and makes me pay for it.

But what I hate worse is living every day in increased pain. Knowing that I'm sensitive to gluten gives me a choice. It gives me power, to some degree, over my fibro symptoms. I can still have that slice of pumpkin pie at Thanksgiving, but I know it comes with a price.

Whenever I'm tempted to cheat on my diet, I ask myself, "Is it worth it?" And so far, the answer is no.

Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained symptoms. Donna writes about fibromyalgia research, treatments and other topics in her blog Fed Up with Fatigue, including a related post entitled “10 Great Websites for Going Gluten Free When You Have Fibromyalgia.”.

Donna is an award-winning journalist whose work has appeared online and in local newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Wear, Tear & Care: Dressing for Comfort and Success

By Jennifer Kain Kilgore, Columnist

Comedian Patton Oswalt once apologized for all the times he made fun of sweatpants. 

“I thought the pinnacle of mankind would be Mars colony or teleportation. Nope! Sweatpants! That was it. Sweatpants!” he said. “We started with fire and the wheel and writing, agriculture, penicillin, sweatpants. Everything else, we’re just on the downward slope. We did it. We’re all done.”

Oswalt went on to say how one never puts sweatpants on after showering; they’re always worn over “deodorized flesh,” with which I disagree. Why? Because I just took a shower and then put my sweatpants back on. (That’s not the point of this post.)

If you are one of the approximately 60 million people in the world with chronic pain, you know that regular clothes can just hurt. It becomes a burden to wear something as regular as jeans. We operate by feel alone.

What is comfortable? What doesn’t compound our pain? What feels good against our tortured skin?

Sweatpants!

This obviously was a problem for me when I was in the working force. An attorney cannot wear sweatpants to court or when meeting with clients……. or can she?

Behold:

That’s me. This outfit was actually remarkably comfortable. Want to know why? Those are Clarks Kearns Blush boots (literally one of three pairs of shoes I can wear that provide support for my back) and Betabrand’s Dress Pant Yoga Pants.

They work better than, say, black sweatpants or regular yoga pants, because they have fake buttons and pockets. They look like real pants. They are deceptive. It’s a genius idea that fools both court officials and other attorneys into thinking that I am appropriately dressed.

They’re a bit pricey, but they are totally worth it. I own three pairs because regular pants just hurt when my sciatica runs down my legs or my low back starts firing off. I want to be as comfortable as possible, and even well-worn jeans cannot make that happen.

Bonus point for the Dress Pant Yoga Pants: They are one of very few styles that can hide the Quell device.

The jacket is also the same kind of sweatshirt-ish material and was found at H&M.

Betabrand makes a number of products designed for office comfort like the Work-It Skort and the Travel Dress Suit, as well as a zip-up suit "onesie" for men. Not quite sure what I think about that one, but you have to admit it looks pretty convincing.

These can be lifesavers for people who choose clothes by comfort level instead of presentability, as they allow us to achieve both objectives instead of them being mutually exclusive.  

The bottom line is that chronic pain patients no longer have to make concessions when it comes to fashion. We don’t need to go outside looking like hobos just because we feel terrible.

It’s common knowledge that by looking good, we can fool ourselves into feeling good. It’s difficult to face the world when you are only armed with sweatpants and no makeup. That’s why I try to wear even just base makeup on a daily basis; you never know who might knock on the door or who you might run into while outside the house, but more importantly, I like feeling pretty.

Sometimes it’s hard to get the motivation even to put on the Betabrand pants, because I associate those with work now. However, I know that when I wear them, I look like I belong in the professional world… and that feels great. 

J. W. Kain is an attorney in the Greater Boston area who also works as a writer and editor in her spare time.  She has chronic back and neck pain after two car accidents.

You can read more about J.W. on her blog, Wear, Tear, & Care.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Pain Companion: Breathing Exercises for Chronic Pain

By Sarah Anne Shockley, Guest Columnist

Can your breathing patterns actually affect your pain levels?

Over several years, and born from the desperation of having no effective pain remedies, I discovered some simple breath exercises which helped decrease my acute pain levels and increase my overall well being.

In the fall of 2007, I contracted a particularly severe case of Thoracic Outlet Syndrome (TOS). Briefly stated, the area between my collarbones and first ribs collapsed, squeezing the nerve ganglia, muscles, arteries, and veins that have to fit through an already narrow breathing space.

This caused a myriad of symptoms, including burning, aching, shooting pains, and tingling in my hands and neck, and a reduction of mobility and function in my neck, arms and hands.

Over the next several years, I tried various forms of physical therapy and a number of pain medications, none of which improved my TOS and most of which exacerbated the squeeze in the thoracic area, inflamed the nerves, and swelled the tissues even more, causing more pain.

Finally, I was pronounced permanently disabled and left to my own devices.

The only thing I'd found that helped keep my pain levels stable in all that time was walking. So, walking slowly for about 20-30 minutes a day and staying as quiet and calm as I could became the sum total of my pain management protocol.

After several years of stoically putting one foot in front of the other, both figuratively and literally, I thought, there has got to be something else I can do here.

I meditated before my injury and knew that calm meditation was often good for reducing stress as well as increasing overall health, so I thought it might help my nerve pain. It certainly couldn't hurt.

Except that it did.

The meditation forms I was familiar with called for sitting with an erect spine and breathing deeply and evenly.

Unfortunately, sitting in any one position for more than a few minutes increased my pain. Trying to keep my spine straight increased my pain. Breathing deeply increased my pain.

So much for meditation. Every so often, I would try again to see if anything had changed, but got the same results.

Yet something good did come out of it. In the process of trying, I began to pay attention to my breathing, at least for a few moments. Eventually, I noticed something startling.

Every time I began my brief little excursions into meditation, I noticed that I was holding or restricting my breath, as if I was afraid to breathe at all.

So I began watching my breathing patterns and putting my attention on my breath at various times during the day, whenever I thought of it.  I didn’t do anything else at first, I just paid attention.

What I noticed was that I was taking very shallow breaths and then stopping my breath in between them. I don't mean that I was filling my lungs with air and holding my breath. I mean I was barely breathing. Since breathing deeply increased my pain, I was unconsciously trying not to breathe.

This is understandable, and maybe it's something that you do too. If you check in with your breath right now, are you inhibiting its flow in order to try not to feel pain? Just notice that.

The problem with holding back the flow of breath is that it blocked the natural flow of oxygen in the body, and made the body tenser. I realized that I might be inhibiting the body's natural healing process by inhibiting the breath.

So, I started some experiments.  The first thing I did was notice my breath at different times during the day.  Then, I started consciously taking an easy breath and releasing it a few times calmly and freely. I didn't try to breathe deeply since that increased my pain, I just simply released my breath to flow more naturally.

The second thing I did was stop using my breath to push against pain. That meant I had to let pain be where it was without as much resistance from me. It was as if, by withholding breath from the pain - trying not to breathe in the painful area - I could force it to leave, or die, or I wouldn't have to feel it.

The third thing I did was to begin to breathe with the pain. In a sense, I included pain in my breath, rather than trying to stop it by not breathing in the painful area. I first imagined breathing around the pain, and then I imagined breathing through the pain, and then I imagined breathing with the pain, as if pain were breathing with me at the same time.

In short, I allowed pain to have breath.

This seems counterintuitive to most of us. We want to stop our pain, so we stop the flow of our breath. But it doesn't seem to work that well. Pain is already part of our experience, so resisting it doesn’t usually bring good results and it creates more stress and tension in the body.

Accepting pain for what it is and breathing with it helped me create a great deal more relaxation in the body, and thereby began to relieve the acute levels of pain I was in.

It seems like a paradox, but I found that giving pain permission to be where it was, so to speak, and allowing it breath, actually helped it to begin to move on.  I also noticed increased energy in my body overall, and I felt better emotionally.

After having worked with breath for several years now, I can say that, for me, these little breath awareness exercises have made a great deal of difference in my pain levels and overall well-being.

Sarah Anne Shockley is the author of The Pain Companion: Practical Tools for Living With and Moving Beyond Chronic Pain.

Sarah also writes for her blog, The Pain Companion.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

How I Found Hope for Fibromyalgia

By Lynn Phipps, Guest Columnist

The year 2004 began for me a decade-long nightmare. Bedridden with severe body pain and disabled from 3 migraines per week, I lost my career as a social worker, ironically working with people with disabilities. I lived with severe pain and bone crushing fatigue daily.

Before I became ill, I didn’t believe in fibromyalgia. I was so wrong.

My diagnosing physician treated me with the standard medications for fibromyalgia, chronic fatigue, post traumatic stress disorder, migraines, anxiety, depression, and pain. None of the three FDA approved fibromyalgia medications worked. A combination of Norco and Butalbital taken every 4-6 hours managed the pain and migraines, giving me some ability to function.

Over time, I was able to take the pain medications less often, every 6-7 hours. I was taking care of my hygiene, my family and home again. The pain medications allowed me to move more, which is essential for managing fibromyalgia pain. I began exercise again for about ten minutes a day.

I remained his patient for 7 years until he yelled and humiliated me when I asked for a prescription for one migraine pill while out of town. I had forgotten to pack mine. He treated me like a drug addict and called me a liar. I was stunned, as that was the only time I had ever asked him for pain medication. I fired him.

Only one physician out of thirty was willing to take my case because it was so complex. I had to wait eight months for an appointment.

lynn phipps

In the meantime, I was seen by a PAC (physician assistant, certified) at a local clinic. I also tried alternative therapies such as acupuncture, massage, and herbal remedies. I tried hydrotherapy, saw countless physical therapists and chiropractors, all claiming they could cure me. Nothing worked. I was becoming fatigued to the point that I could no longer drive to my appointments. Discouraged, I gave up all hope of getting better.

I was referred to a pain specialist whose specialty was to find the nerves causing the headaches and cauterize them. The theory was that scar tissue would then form on the nerves, blocking the pain. It didn’t work. I was afraid at every appointment that he would stop prescribing Norco because he did not believe in pain medication. One year later, he did.

I couldn’t believe that a pain specialist would take away all of my pain medications. I hadn’t misused or abused them. I took less than prescribed. It was cruel. He helped me titrate off of Norco, because studies indicate they cause rebound headaches. He was right, but I was still in so much pain that I was not functioning. Two years with no pain relief had him referring me to a pain psychologist.

The pain psychologist determined that I was not a meanderer; that, in fact, my pain was legitimate. Vindication! He then changed my life by telling me that if I were ever to get well, I had to go to a larger metropolitan area.

A google search led me to an MD in San Francisco who specializes in treating fibromyalgia. A fibromyalgia patient herself, she understood my diagnosis. She explained that she got her life and career back after two years on something called the Guaifenesin Protocol, which includes taking an expectorant drug to clear airways in the lung. It was not a cure, but followed precisely, would reverse the fibromyalgia symptoms.

The basic principles of the Guaifenesin Protocol include finding the proper clearing dosage, eliminating the use of all salicylates (a natural chemical found in plants, as well as household and hygiene products) and following a low-carbohydrate hypoglycemic diet to combat low blood sugar, which mimics many fibromyalgia symptoms.

The Guaifenesin Protocol helps sluggish kidneys excrete the build up of phosphates, which are believed to be the cause of fibromyalgia symptoms, at a rate of six and a half times faster than without it. Over time, this leads to the reversal of fibromyalgia symptoms.

For the first time in three years, I felt hopeful. The doctor examined me and agreed with the  fibromyalgia diagnosis, stating I was one of the worst cases she had seen. She also reviewed recent lab work, discovering that my blood sugar was slightly elevated. She suggested a hypoglycemic diet. Within 6 weeks of the diet, I had more energy and less pain.

I have been taking Guaifenesin and following a hypoglycemic diet for 14 months. Before I made these changes, I had 62 of the 68 most generally accepted Fibromyalgia symptoms.

I now have only 14 fibromyalgia symptoms. I am taking only four prescription medications instead of thirteen. I am off all pain medications. And I am no longer bedridden.

Lynn Phipps lives in northern California with her family. Lynn has a degree in social work and is currently helping fibromyalgia patients navigate the Guaifenesin Protocol at FibromyalgiaWellness.info.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Committee Approves New Drug Implant

By Pat Anson, Editor

An advisory committee to the U.S. Food and Drug Administration has approved a new drug delivery system to treat opioid addiction – an implant that could potentially be used to treat chronic pain and other diseases that require steady doses of medication.

The FDA’s Psychopharmacologic Drugs Advisory Committee voted 12 to 5 in favor of the new drug application for Probuphine, a tiny implant about the size of a matchstick that contains buprenorphine, a drug already used to treat addiction that currently only comes in pills and oral film strips. The FDA is expected to make a final decision on Probuphine next month.

“You can never be 100 percent sure of anything,” said Sunil Bhonsle, CEO and president of Titan Pharmaceuticals (NASDAQ: TTNP), which partnered with Braeburn Pharmaceuticals in developing the implant. “The data clearly shows that this product can be of benefit to this patient population. And we hope the FDA will approve it.”

COURTESY BRAEBURN PHARMACEUTICALS

Once implanted under the skin, Probuphine is designed to deliver a steady dose of buprenorphine for six months. Buprenorphine is a weaker opioid that’s long been used as an addiction treatment drug sold under the brand name Suboxone. While it reduces cravings for opioids, buprenorphoine can also be abused and is prized by addicts as a street drug that can ease withdrawals pains from heroin.

The advantages of an implant are many. The dosage is controlled and there’s hardly any risk of abuse, diversion, or accidental overdose. Users also never have to remember to take a pill.

Probuphine’s path to the marketplace hasn’t been a smooth one. Braeburn and Titan were stunned in 2013 when the FDA denied approval of the implant and asked for a new clinical study proving Probuphine’s effectiveness in treating opioid addiction.

The results of a six month, double-blind clinical trial on 177 patients, found that the implant was more effective than buprenorphine film strips in treating addiction. The implant’s insertion and removal were "generally well tolerated," although nearly one in four patients had a "mild" adverse event at the implant site.

Several members of the FDA's advisory committee, including its chairwoman, voted against approval, saying there was not enough evidence of Probuphine’s effectiveness after six months.   

"New treatment options for the millions of patients and their families suffering from opioid addiction are desperately needed, and we appreciate the Committee's comprehensive review of Probuphine," said Bhonsle. “There are many applications for this technology and I think the medical community is now more in tune with looking at long-term delivery technology in the chronic disease setting. So I think it’s probably accurate to say the time is right to expand the use of these technologies to different settings.”

Bhonsle says Titan is already looking at ways the implant can be used to treat Parkinson’s disease and hypothyroidism, adding that chronic pain could also be treated with an implant.

“Clinical studies will need to be done to establish the ability, but the drug levels can certainly be delivered that are going to be beneficial for treating chronic pain,” he told Pain News Network.