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N C C A M Research Blog

Let's Get "Pragmatic" About Pain

April 29, 2013
Dr. Briggs
Josephine Briggs, M.D.

Director
National Center for Complementary and Alternative Medicine

View Dr. Briggs' biographical sketch

Since the beginning of NCCAM, the starting point for us has been the “real-world” use of complementary health approaches. Over time, we have supported a number of surveys and other observational studies, and have learned a good deal about the choices Americans are making in complementary approaches, the reasons they cite, and the associated costs. There is more to learn, of course, but we have pretty good descriptive data about real-world practices. And we have learned that the focus of most use is on pain management. But observational data, by itself, does not answer some important questions. In fact, it does not really test what works and what doesn’t work. So now we are beginning to ask: How can we bring the rigor of the randomized controlled trial to learn more about what is actually helping people manage pain in the real world?

The “real world” question is an active topic across the National Institutes of Health (NIH), reflected in growing interest in what are being called effectiveness studies or pragmatic trials. Of course, NIH clinical studies happen in the real world, but usually under conditions that are tightly specified and controlled. In the typical interventional study—whether it is of a new drug, a procedure, or a new behavioral approach—simultaneous use of other therapies is limited, patient eligibility criteria are closely specified, only highly experienced practitioners are engaged, nurse coordinators closely monitor compliance, and so on. Careful control of all aspects helps ensure study results can be replicated. It helps to create “internal validity.” And, by reducing the sources of variability, we reduce the need for large numbers of participants. But, there is a tradeoff in this approach to trial design. At least sometimes, when the results are implemented in real-world conditions, the intervention does not work as expected. Hence, the concept is gaining acceptance that we need both explanatory studies to test the efficacy of therapies and pragmatic studies to examine real-world effectiveness.

Investigators interested in improving the translation of research findings to the real world have developed an approach to assessing trial design—called PRECIS criteria, a pragmatic-explanatory continuum indicator summary. This tool categorizes clinical trials on a number of criteria, aiming to explore whether the trial design fits the overall goals of the research. Trials are considered to be pragmatic if they have broad participant eligibility, typical practitioners, interventions implemented flexibly, and an analysis that captures objective evidence for all patients. I urge our investigators to look at the literature on pragmatic study designs and to think with us about their potential applications to NCCAM’s research mission. 

There are many practical questions emerging from our pain portfolio that seem ready for a more pragmatic approach. We have growing evidence, reflected in systematic reviews and practice guidelines, that a number of the mind-body therapies can have real benefit in pain management. But these results raise many new questions. Do these approaches improve patient well-being when they are integrated into primary care settings? What works well in pain clinics that see referral patients? Do the mind-body approaches reduce opioid abuse? What patient populations are best targeted? How can providers effectively encourage models of self-management?

The list is long. And the problem—chronic pain—is a very tough one.

We welcome your thoughts.

 

Comments

Comments are now closed for this post.

Suggestion:Bless all those who conduct research, produce clinical programs, drug developement, etc.  My suggestion is that; LISTENING TO THE PATIENT is the single most important process that a doctor will really make a difference.  Without this first and most important step, no other action will make a significant difference and maybe worsen the medical issue.  Listening rarely ever happens and because of this the condition usually worsens.

The least invasive means of relieving pain is largely overlooked by the medical community.  I’m referring of course to Trigger Point Therapy.  Contrary to popular opinion, it doesn’t require the client to withstand great pain.  Drugs work for only a little while; the methods used by physical therapists actually can exacerbate the problem by stretching an already injured muscle.  Ischemic compression is effective treatment of trigger points, and used in conjunction with any one of a dozen other techniques, surprisingly painless. 

There is NO way to conduct a randomized study on pain relief without subjecting the placebo group to pain. Therefore there is no sensible way to do so and the idea shold be dropped.

 Pain is inflammations are non-self-stop the inflammation and non self and stop the pain in any one young are old and any race.  Aloe Vera is an excellence anti-inflammatory and non-self-inhibitor. Example there was a patient and many others on hydrocodone and other pain drug who wanted off them due to the many side effects and minimum effect on the pain. Patient withdraws prominently from the drugs drinking pure Aloe Vera juice approximately two 8 ounce glasses a day with no bad side effects.  Ivan Danhof, M.D., Ph.D is an expert on the therapeutic effects of Aloe Vera Google his name and read his material. There are many other natural approaches to eliminate pain, but there is great bias toward these modalities

Make all modalities, alternative andWestern medicine more avail to chronic pain suffer’s. I am a current Veteran’s Admin patient and all I have at my disposal that I can afford is opiods and a class on bio feedback. Would love accupuncture, auryveda for depression and nutrition, massage and yoga classes.  All near by my home instead of an hour + just to see Pcm, which just makes pain worse by driving so far. 

I provide Reflexology, Aromatherapy, Foot Ionization Hydrotherapy Spas and Reiki to my clients. I work at an office that provides multiple types of Massage, Acupuncture, and CranioSacral Therapy. We find that sometimes just the process of taking an hour for yourself, just to relax with no worries, is exactly “what the doctor ordered”.A number of conversations are also about the little things that we can do to improve our health: breathing deeply & fully; walking those few extra steps each day; drinking plenty of water while reducing or eliminating sugary & caffeine drinks; adding more vegetables & fruits, especially organic & locally grown; eating less processed foods. As practitioners who care about health, we are continuously hearing about what works and passing that on to our clients/patients. Empowering them to take charge of their health by giving them some simple tools, the information that they can easily make changes, is key to their overall well being. We encourage them to remember that Body Mind & Spirit all need to be in balance for their continued wellness. From this viewpoint, when conducting research, it would be important to know not only what modality is being used, but what is said during a session. Just as one doctor may be more effective than another with their “bedside manner”, so too may complementary health practitioners.

thanks all

Pamela Stanley on May 1, 2013 - 5:13am and Diana Limberis on May 1, 2013 - 2:29pm  I’m board certified Naturopathic Doctor license in the state of D.C. and since I work for federal goverment that make me licensed in all United States. I work for Veterans Affairs in a Hybride Title 38 position as a Medical Support Assistant. Over the past 5 years working for the VA I have help many veterans with crippling pain to pain free using natural approaches. All verterans was completely satisfied with the result the natural approches got for them. I use my knowledge as a education tool for the veterans in need of such approaches when traditional approaches has fail. There are many approaches to pain without drug are cutting.  

 In my dealing with drug addicts a lot of them revert to street drug when they do not get the good result with medication for pain unaware there are natural simple and low priced approches that work.

whether the pain really be lost without taking medication? Thanks

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While I appreciate greatly any efforts that people soldier to deal with their chronic pain, there is a lot of pseudoscience that needs to be called out for being simply false hope. When desperation sets in, it is not fair to tell sufferers that some distance healing or reflexology, for example, will help them deal with their pain. Palliative care should be done in the context of compassion, but not promulgation of nonsense. A listening ear, a caring word, a sympathetic touch, and a relaxing environment are all ways we can begin the process to help, but the charlatans and nonsense peddlars who are profiting off of the misery of others need to be stopped. The great tragedy of pain relief is that opiates can actually work wonders for pain management, but the side-effects are so great that doctors are afraid to use them. We don’t have a compassionate or objective way yet to figure out how to deal with pain management vis-a-vis narcotics, so in too many cases the medical science errs on the side of caution to forestall medical complications, side-effects, or even death down the road. While it makes sense that such treatments can be abused, our current system of knee-jerk denial should be subject to better and more controlled research. Has the pendulum swung too far away from the fear of the problems of opiate dependency that we are condemning people to lives of horror and pain? At what point does it become a good idea to sacrifise a risk down the road for a relief of a pain so debilitating that a person cannot function or engage meaningfully with their life? These are questions that need to be taken seriously and answered in the context of each person’s individual care. It is problematic that the conversation is happening here on the NCCAM side of the NIH research rather than in the context of qualified professionals who have a background in evidence-based treatments and proper medical science. While I understand that pain management may be a neglected topic, the answer is not to grasp at straws. I think it is important that we discover how people are using alternative treatments to deal with their pain, but we should be looking more closely at how to manage the pain in the context of treatments that we know have plausible mechanisms rather than spending valuable resources on re-asking questions about chiropractic, homeopathy, acupuncture, therapeutic touch, reiki, and the like which are all without evidence for efficacy and are simply acting as a way to bilk the suffering patient.

JPS on May 15, 2013 - 9:40am: “we should be looking more closely at how to manage the pain in the context of treatments that we know have plausible mechanisms rather than spending valuable resources on re-asking questions about chiropractic, homeopathy, acupuncture, therapeutic touch, reiki, and the like which are all without evidence for efficacy and are simply acting as a way to bilk the suffering patient.” —- “all without evidence”?! I don’t agree with this statement. NCCAM has done a great job making this much needed conversation going, and they have distributed many published studies regarding the evidence.  Not all CAM modalities have been supported by evidence, but some of them have shown promises.  For instance,  the recent published meta-analysis regarding acupuncture and chronic pain is noteworthy.  (http://www.ncbi.nlm.nih.gov/pubmed/22965186)

Just listened to a webinar today from the head of a consortium of clinicians, practitioners and researchers committed to addressing pain in later life. There was so much good, cutting-edge info covering the whole spectrum of pain, its effects and the desperte need for focused, well-designed research. The info/slides, etc., are to be available on the Translational Institute for Pain in Later Life’s (TRIPLL’s ) website. As a therapeutic yoga teacher who encounters lots of pain — and the easing of pain — in those I work with, I was thrilled to hear Dr. Cary Reid recommend the Arthritis Foundation’s evidence-based yoga program, now on a DVD.TRIPLL recognizes chronic pain as a “disease” in itself to be addressed and not just to be considered a byproduct of other conditions. All these efforts — and yours — including those of the VA and the military, which really are groudbreaking (see Wayne Jonas’ testimony before the Senate on complementary approaches on the Samueli Foundation’s website) are sure to find effective ways to bring relief.

I appreciate the comments.  @JPS, Thanks for weighing in. I think if you read my post from June 2012, you’ll find that we’re very much on the same page. In fact, the use of complementary health approaches is largely in combination with conventional medicine, rather than as an alternative to proven medications such as opiates. Thus, much of our research focuses on these approaches as adjuncts to conventional care.

 

I also invite you to read my post from February of this year which provides a link to our FY2012 New and Competing Awards so you can get a better sense of what we’re currently studying.

I agree that listening to the patient is the best approach as it is only through listening that one can discover what works for a partcular patient. Western medicine works for some, not for others. Varied responses to pain medicines is a prime example in that it not only does not work for some, but can cause problems such as addiction for some patients. It is the same for all other therapeutic forms, frequently referred to as “alternative medicine”. For example, yoga and meditation may work for some, myfascial release or trigger point release may work for some, Ayurvedic principles and inflammation treatments such as shilajit may work for some. Embracing a broader approach and listening as well as observing hard data for results are key to overcoming the challenges of pain management. 

Very well said JPS. It is worthwhile to note that the paradigm of pragmatic studies is indeed very useful and arguably much needed. However, it is important to note the limitations of such studies - they simply cannot be use to provide evidence in favor of efficacy of a treatment. In all cases the use of a pragmatic trial can only dilute the effect size and add uncontrolled bias into studies that make them prone to spurious results. In the case of an already proven effect, this could be very useful in determining what the actual effects are in a real-world scenario. But without the a priori establishment of safety and efficacy a pragmatic trial can tell us nothing useful on its own. The pragmatic trial is, however, where rank pseudoscience can thrive. Implausible to the point of nearly impossible modalities like energy healing (reiki, therapeutic touch, reflexology, qi gong, etc) can find spurious positive effects due to this uncontrolled bias coupled with a good dose of placebo response. While it is noted that the NCCAM supports the “integration” of these “alternative” modalities alongside actual medical care, it seems to me that it makes no sense to “integrate” something that has no effect demonstrable in rigorous trials and is likely nothing more than elaborate placebo alongside actual medical care. If the stand-alone effect is negligible, bundling it with actual medical care does nothing to add to the quality of care nor improve outcomes, but merely adds cost and potential risk.