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

Backtivity - searching the world for a back pain cure, for you, by you

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]

For a very different kind of study, I used the search terms “Phase 2,” which means it is a very early stage study, “low back pain,” and “surgery.” Because this is such an early stage study, the medication has yet to be named; it is identified as a strange combination of letters and numbers, “JNJ-42160443.”

The Purpose is

to compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe low back pain patients with a diagnosis of chronic low back pain.

Here’s that placebo thing showing up again; in this case, an injection of basically water. So why participate in a study if there’s a chance you may get a placebo? Well, for one, you usually get a very comprehensive assessment of what’s causing your pain. I’m a little surprised that more extensive imaging (MRI or CT scan) is not included. This is a somewhat dated study from 2009; more current studies may include more imaging. For another, you get an evaluation that is unaffected by whether or what kind of insurance you have. This can be important. Unfortunately, there are still physicians in this world motivated to follow one course versus another based on money.

The Eligibility criteria include one very simple inclusion criterion: “Diagnosis of chronic low back pain.” Chronic is arbitrarily agreed upon as 3 months of nearly daily pain. There are more exclusion criteria and most are obvious and not common.

The Primary and Secondary Outcome Measures also list questionnaires and pain assessments; the PGA in “PGA score” stands for Patient Global Assessment.

Here, the Arms include 4 different doses of experimental medication — with one group getting 10 TIMES more medication than another…WOW! But each dose of active medication is compared to a placebo group. The statement,

One inj … every 4 wks for up to 104 wks

gives you a clue that you’d have to go into the clinic at least once a month for up to 2 years. That can also be important in deciding whether to participate.

So these are two very different kinds of studies that people choose to participate in. Most people discover studies because they go to a clinic that does them. Another very common way people find out about the studies is by having participated in a previous one. The overwhelming majority of people who have done in a study ask to be signed up for another.

And then a third way to find out about studies is by going to a website, researchmatch.org, where you can provide some information about your health condition and the study investigators can contact you if you are a good match. I’ve talked to several people who found a study this way and they were very happy with the response. Some say they are offered more studies than they can handle but it’s easy to just not reply.

One method I would not recommend to find studies is in a newspaper ad. There are some shady clinics that use the promise of a study to hide a sales pitch.

I hear the expression, “Clinical research is the best medical care you can’t buy.” There’s a lot of truth to that. You definitely get more time, attention, testing, and education than in any other clinic or hospital setting. No matter how much money someone has, they can’t buy participation in a study. The physicians don’t know or care who has insurance or what kind…they just want to find people who are most appropriate for the study. And the physicians and clinics must play by the rules. There are many checks and balances in the system to verify and re-verify that the right people are in the study and they are receiving proper care.

One final note about finding a trial: the website isn’t geographically savvy. They prompt you to enter a condition and city. Unlike most websites, they don’t give you the option of narrowing down to 50 or 100 miles from your zip code so you may just want to enter your state or country.

Please drop me an email or tweet to let me know if you inquired about participating in a study. I would also like to hear from those who are not interested in participating in any study and why.

Thank you.

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