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How (and WHY) to get into clinical trials - Backtivity - searching the world for a back pain cure, for you, by you

How (and WHY) to get into clinical trials - Backtivity - searching the world for a back pain cure, for you, by you
Dec 17, 2015 · 11m 44s

I spend about half my time doing clinical research and half treating "real patients." They are certainly different conditions. In a nutshell, real patients are scheduled for appointments and those...

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I spend about half my time doing clinical research and half treating "real patients." They are certainly different conditions.

In a nutshell, real patients are scheduled for appointments and those visits are getting shorter and shorter. Much more time is required for these patients if we are doing our jobs right by updating our findings on physical exam, asking about side effects of medication, quality of life, function, sleep...the list is long. On top of that, because fewer physicians treat chronic pain, those who do are getting backlogged, often taking months to get an appointment.

Patients in clinical trials are sought after. They must meet very rigid and specific requirements that usually include all aspects of a condition -- history, a diagnosis (based on very specific criteria), medications, labs, imaging, other treatments, and more. In evaluating someone for participation in a trial, they receive the most extensive and accurate testing/diagnosis, not to mention what is often a new, improved treatment.

I want to give you some examples using 2 actual clinical trials. The first is an exercise-based study and the second is medication-based.
1. Exercise-based clinical trial for low back pain
[you can follow along with by reading the trial details here]

I found this particular study by going to a government website, clinicaltrials.org, and entering search criteria "low back pain" and "exercise." You'll probably also want to limit the search based on country and/or state though there are times when you may be willing to travel some distance (e.g., if you have a rare condition or are willing to participate in a study in the early stages of experimentation in people -- usually identified as a "Phase 2" trial).

I'll bypass some important but obvious details such as where and when the study is being done. After that, probably the most important thing to focus on is what the study is evaluating. You should be on the default tab, "Full Text View." Near the top of the page, you'll see Purpose which is
to investigate if high-intensity resistance training can induce additional beneficial effects, for patients with moderate to severe long term pain in the low back
So, if you don't want to participate in a high-intensity resistance training exercise, this wouldn't be for you. Neither would it be right if your pain wasn't moderate to severe or if pain is in your neck or upper back.

Next, do you meet the Eligibility criteria? Both the inclusion and exclusion criteria are important. Much of this is in doctor talk but you can easily google the interpretation. As an example, "Pain intensity ≥ 4 on numerical rating scale" is just those happy to sad faces representing pain.

How are they assessing whether this experimental treatment actually works? Look under Primary and Secondary Outcome Measures and you'll see a list of questionnaires, strength tests, and disability scores.

Finally, what are people participating in the study actually doing? In this study, they list doing's (or interventions) under Arms. Not as in Upper Body Workout but an experimental arm doing High-intensity resistance training and the Active Comparator (or usual care arm) doing General physical activity.

Now, to anyone doing hardcore weight training --
strength training with Theraband Elastic bands
it's just not possible to reach a level of "high-intensity resistance training." So this may be a deal-breaker for you, not worth inquiring any further.

Take note that one group is basically getting the same 'ol advice that they would get by going to a physician/ GP. In other studies, it may be a placebo or sugar pill with no active ingredient.
2. Medication-based clinical trial for low back pain
[you can follow along with by reading the trial details here]
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