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“I was a little surprised”: Qualitative Insights from Patients Enrolled in a 12-Month Trial Comparing Opioids to Non-Opioid Medications for Chronic Musculoskeletal Pain

Chronic musculoskeletal pain is a major public health problem, associated with disabling physical and emotional consequences for patients and with significant costs related to medical treatment and lost worker productivity.16 Use of opioid analgesics to treat chronic pain has increased dramatically in recent years,7,25 paralleled by increases in opioid-related harms, including addiction and death.1,23,34 While harms of opioids have become apparent, evidence for long-term effectiveness of opioids for chronic pain is lacking; a recent systematic review found no randomized trials that examined effects of opioids on pain, function, or quality of life at one year or longer.

“I was a little surprised”: Qualitative Insights from Patients Enrolled in a 12-Month Trial Comparing Opioids to Non-Opioid Medications for Chronic Musculoskeletal Pain

Orginally Published At: Pain Journal

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Dr. Travell “dry needled” with a harpoon

I’ve been working on series of updates to the dry needling chapter in my trigger points book, gradually building it up to the point where it would make a good, substantive article on this topic in its own right. It must stay in the book, but here’s an interesting excerpt that I just have to share with everyone today.

A little context first, though: modern dry needling involves stabbing “trigger points” (sore spots in soft tissue of unknown origin) with acupuncture needles. Overlap between acupuncture and dry needling is partial/confusing, but the use of acupuncture needles for this purpose today is almost universal. No one’s using anything else. Which makes this rather interesting…

The term “dry needling” came from Dr. Janet Travell herself, many moons ago. In the original big red books, she used the term to describe lancing a trigger point with a hypodermic needle, but not injecting anything. (Ouch!) She did not go into any detail, but her method is definitely distinct from modern dry needling, which is much more directly “inspired” by acupuncture. Although Travell didn’t explain her rationale for dry needling, she did explain why she never used an acupuncture needle: she thought they were too fine!

There has never been a shred of empirical evidence that suggests that any rationale for dry needling is superior to any other. Like mutually exclusive religious beliefs, they clearly can’t all be right. The fact that Dr. Travell disapproved of acupuncture needles is fascinating and irksome — she is virtually worshipped, her book is still the bible of trigger point therapy… and yet no one using acupuncture needles today has offered an explanation of why they are ignoring her opinion on this. If she was wrong, then it casts doubt on the Mother of Trigger Point Therapy (doubt that is absent from nearly all references to her work). If she was right, then dry needlers have been barking up the wrong tree for a long time.

Or perhaps they are all wrong. Because how dry needling might work is a moot point if it doesn’t work. So…

And then the book continues with an evidence review that does not have a happy ending.


[Image caption] One hypothesis is that stabbing “inactivates” trigger points by wrecking the neuromuscular junction (motor endplate). Here’s four of those, at the ends of branching motor neurons, attaching to muscle fibres. Each one is about 3µm (.03mm) wide, roughly a tenth the diameter of an acupuncture needle. Trying to hit one of these like trying to use a spear to stab a raisin under a metre of Jello. Or a harpoon, if you’re using a hypodermic needle.

The “negative” trigger point book

My trigger point book is a 130,000-word beast, much longer than the average novel, and there are chapters in there I haven’t touched in a decade, like boxes in your attic that contain God-knows-what. Sometimes I open it to a random location, read three paragraphs that make my head explode, and I have to spend the morning bringing it up-to-date (instead of whatever 62 things were on my to-do list).

I never stop modernizing my books, and in the case of the trigger points book, “modernizing” mostly means making it more of a bummer for people who want to believe that trigger points are the key to all pain. It’s the only book about trigger points that discourages people from getting too overheated about trigger points. It’s all about managing expectations now, and the chapter on needling is an excellent example of this trend.

(If you think trigger points “don’t exist” and/or you’re still unclear on why I am not much more dismissive of the idea of trigger points than I am — I do still sell a book about them, after all, even if it is relatively “negative” — my position on this controversial topic is exhaustively spelled out here: Trigger Point Doubts. The highlights are covered by about dozen bullet points early in the article.)

[Go to this post on PainScience.com]

Dr. Travell “dry needled” with a harpoon


Orginally Published At: Pain Science

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Pilot Randomized Trial of Integrated Cognitive-Behavioral Therapy and Neuromuscular Training for Juvenile Fibromyalgia: the FIT Teens Program

• Results of this pilot trial of the FIT Teens program were promising• FIT Teens was more effective than CBT-only in the reduction of disability and pain• Mood symptoms improved, and fear of movement was reduced after FIT Teens

Pilot Randomized Trial of Integrated Cognitive-Behavioral Therapy and Neuromuscular Training for Juvenile Fibromyalgia: the FIT Teens Program

Orginally Published At: Pain Journal

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Randomized Controlled Trial of Nurse-Delivered Cognitive Behavioral Therapy Versus Supportive Psychotherapy Telehealth Interventions for Chronic Back Pain

• Two telephone-adapted behavioral therapies improved chronic low back pain• A nurse-delivered cognitive behavior therapy reduced pain and improved function• A nurse-delivered supportive care improved pain outcomes equivalent to CBT• Effect sizes were moderate, ranging from .33-.60 for pain severity and function.• 27-39% of the participants reported “much improved” or “very much improved”

Randomized Controlled Trial of Nurse-Delivered Cognitive Behavioral Therapy Versus Supportive Psychotherapy Telehealth Interventions for Chronic Back Pain

Orginally Published At: Pain Journal

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Hypnosis Enhances the Effects of Pain Education in Patients with Chronic Non-Specific Low Back Pain: a Randomized Controlled Trial

• Hypnosis can be combined with education in patients with chronic low back pain.• The addition of hypnosis improves pain intensity, disability, and catastrophizing.• The beneficial effects are enhanced, at least in the short and medium-term.• The intervention can be offered in group settings.

Hypnosis Enhances the Effects of Pain Education in Patients with Chronic Non-Specific Low Back Pain: a Randomized Controlled Trial

Orginally Published At: Pain Journal

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Current methods and challenges for acute pain clinical trials

Introduction:
The clinical setting of acute
pain has provided some of the first approaches for the development of analgesic clinical trial methods.
Objectives:
This article reviews current methods and challenges and provides recommendations for future design and conduct of clinical trials of interventions to treat acute pain.
Conclusion:
Growing knowledge about important diverse patient factors as well as varying pain responses to different acute pain conditions and surgical procedures has highlighted several emerging needs for acute pain trials. These include development of early-phase trial designs that minimize variability and thereby enhance assay sensitivity, minimization of bias through blinding and randomization to treatment allocation, and measurement of clinically relevant outcomes such as movement-evoked pain. However, further improvements are needed, in particular for the development of trial methods that focus on treating complex patients at high risk of severe acute pain.
This is an open access article distributed under the Creative Commons Attribution-NoDerivatives License 4.0 (CC BY-ND) which allows for redistribution, commercial and non-commercial, as long as it is passed along unchanged and in whole, with credit to the author.
Corresponding author. Address: Department of Anesthesiology, Queen’s University, 76 Stuart St, Kingston, ON K7L 2V7, Canada. Tel.: 613-548-7827; fax: 613-548-1375. E-mail address: gilroni@queensu.ca (I. Gilron).
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Received August 28, 2017
Received in revised form January 16, 2018
Accepted January 31, 2018
© 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.

Current methods and challenges for acute pain clinical trials


Orginally Published At: PAIN Reports

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Special considerations in conducting clinical trials of chronic pain management interventions in children and adolescents and their families

Introduction:
Disabling chronic
pain is a common experience for children and adolescents. However, the evidence base for chronic pain interventions for youth is extremely limited, which has hindered the development of evidence-based practice guidelines for most pediatric chronic pain conditions.
Objectives:
To review and provide recommendations on clinical trial design and evaluation in children and adolescents with chronic pain.
Methods:
In this article, we summarize key issues and provide recommendations for addressing them in clinical trials of chronic pain interventions in children and adolescents and their families.
Results:
To stimulate high-quality trials of pediatric chronic pain management interventions, attention to key issues including sample characterization, trial design and treatment administration, outcome measurement, and the ethics of intervening with children and adolescents, as opposed to adults with chronic pain, is needed.
Conclusion:
Future research to develop interventions to reduce or prevent childhood chronic pain is an important priority area, and requires special considerations in implementation and evaluation in clinical trials.
This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Corresponding author. Address: Seattle Children’s Research Institute, M/S CW8-6, PO Box 5371, Seattle, WA 98145-5005. Tel.: 1-206-884-4208; fax: 206-985-3262. E-mail address: tonya.palermo@seattlechildrens.org (T.M. Palermo).
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Received November 30, 2017
Received in revised form February 21, 2018
Accepted March 03, 2018
© 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.

Special considerations in conducting clinical trials of chronic pain management interventions in children and adolescents and their families


Orginally Published At: PAIN Reports

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Ethical considerations in the design, execution, and analysis of clinical trials of chronic pain treatments

Introduction:
In the field of
pain research, clinical trials may randomize over 500 subjects and include more than 150 sites spanning over a dozen countries.
Methods:
This review examines the ethical considerations affecting clinical trial design, execution, and analysis of trials for chronic pain. The Belmont Report has been the touchstone for human studies protection efforts since 1979. Commissioned by the U.S. government in response to ethical failures in medical research, such as the Tuskegee Syphilis Study, the report emphasizes 3 basic principles: respect for persons, beneficence, and justice. Trial design and sample size have important ethical implications.
Conclusions:
Measures to enhance trial transparency and combat publication and many other types of bias should be implemented.
This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Corresponding author. Address: California Pacific Medical Center Research Institute, 475 Brannan St, Suite 130 San Francisco, CA 94107. Tel.: 415-600-1750; fax: 415-600-1725. E-mail address: mcrowbotham@gmail.com (M.C. Rowbotham).
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Received August 10, 2017
Received in revised form February 18, 2018
Accepted February 24, 2018
© 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.

Ethical considerations in the design, execution, and analysis of clinical trials of chronic pain treatments


Orginally Published At: PAIN Reports

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Checklist for the preparation and review of pain clinical trial publications: a pain-specific supplement to CONSORT

Introduction:
Randomized clinical trials (RCTs) are considered the gold standard when assessing the efficacy of interventions because randomization of treatment assignment minimizes bias in treatment effect estimates. However, if RCTs are not performed with methodological rigor, many opportunities for bias in treatment effect estimates remain. Clear and transparent reporting of RCTs is essential to allow the reader to consider the opportunities for bias when critically evaluating the results. To promote such transparent reporting, the Consolidated Standards of Reporting Trials (CONSORT) group has published a series of recommendations starting in 1996. However, a decade after the publication of the first CONSORT guidelines, systematic reviews of clinical trials in the
pain field identified a number of common deficiencies in reporting (eg, failure to identify primary outcome measures and analyses, indicate clearly the numbers of participants who completed the trial and were included in the analyses, or report harms adequately).
Objectives:
To provide a reporting checklist specific to pain clinical trials that can be used in conjunction with the CONSORT guidelines to optimize RCT reporting.
Methods:
Qualitative review of a diverse set of published recommendations and systematic reviews that addressed the reporting of clinical trials, including those related to all therapeutic indications (eg, CONSORT) and those specific to pain clinical trials.
Results:
A checklist designed to supplement the content covered in the CONSORT checklist with added details relating to challenges specific to pain trials or found to be poorly reported in recent pain trials was developed.
Conclusion:
Authors and reviewers of analgesic RCTs should consult the CONSORT guidelines and this checklist to ensure that the issues most pertinent to pain RCTs are reported with transparency.
This is an open access article distributed under the Creative Commons Attribution-NoDerivatives License 4.0 (CC BY-ND) which allows for redistribution, commercial and non-commercial, as long as it is passed along unchanged and in whole, with credit to the author.
Corresponding author. Address: Department of Anesthesiology, University of Rochester, Rochester, NY 14642, USA. Tel.: +1 585 276 5661; fax: +1 585 244 7271. E-mail address: jennifer_gewandter@urmc.rochester.edu (J.S. Gewandter).
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Received May 09, 2017
Received in revised form July 11, 2017
Accepted July 24, 2017
© 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.

Checklist for the preparation and review of pain clinical trial publications: a pain-specific supplement to CONSORT


Orginally Published At: PAIN Reports

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Opportunities and challenges for junior investigators conducting pain clinical trials

Introduction:
Clinical investigation serves a vital role to advance treatment and management strategies for patients with
pain. For those new to clinical investigation, key advice for both the novice clinical investigator and the experienced researcher expanding to translational work may accelerate research efforts.
Objective:
To review foundational material relevant to junior investigators focusing on pain clinical trials, with an emphasis on randomized controlled trials.
Methods:
We reviewed recent publications and resources relevant to clinical investigators, with a particular emphasis on pain research.
Results:
Understanding the approaches and barriers to clinical pain research is a first step to building a successful investigative portfolio. Key components of professional development include motivation, mentorship, and collaborative approaches to research. Many junior clinical investigators face challenges in pursing research careers and sparking iterative progress toward success in clinical trials. Pain-specific research metrics and goals—including hypothesis development, study design considerations, and regulatory concerns—are also important considerations to junior investigators who pursue clinical trails. Approaches to build toward collaborative and independent funding are essential for investigators.
Conclusion:
This work provides a foundation for understanding the clinical research process and helps inform the goals and plans of clinical investigators.
This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike License 4.0 (CC BY-NC-SA) which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
Corresponding author. Address: Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins School of Medicine, 600 N. Wolfe St, Baltimore, MD 21287. Tel.: 410-955-1822. E-mail address: bicket@jhmi.edu (M. Bicket).
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Received November 13, 2017
Received in revised form December 05, 2017
Accepted January 16, 2018
© 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.

Opportunities and challenges for junior investigators conducting pain clinical trials


Orginally Published At: PAIN Reports