Improving the Effectiveness of Clinical Trials for Chronic Pain Sufferers

Improving the Effectiveness of Clinical Trials for Chronic Pain Sufferers Blog

Clinical research gives us the best possible information about how best to treat patients’ conditions. When a physician combines the findings of research with his or her own personal experience, though, the results can become even more effective. We call this combination evidence-based medicine. We believe that practicing evidence-based medicine is the best way to make use of modern scientific research when deciding how to treat individual patients.

What Research Is Appropriate for Evidence-Based Medicine?

Evidence-based medicine requires published, peer-reviewed research that doctors and creators of treatment plans can evaluate and verify. Ideally, the authors of the research should support their findings with randomized clinical trials. Trials generally provide ample evidence of the safety and effectiveness of the treatment methods suggested. However, any study can provide useful information if its method and supporting evidence are sound.

Effective Clinical Trials for Chronic Pain Sufferers

A typical clinical trial randomly assigns participants to treatment and control groups. However, we have found that a clinical trial can determine the effectiveness of a chronic pain treatment with far fewer participants involved if everyone involved in the study receives both the control treatment and the experimental treatment. This type of clinical trial is a crossover trial.

One of the problems with clinical trials for chronic pain sufferers is the fact that pain levels are subjective. People experience and report pain differently. You can eliminate the variable nature of pain as a factor affecting the trial by giving all participants both treatments. With proper statistical analysis, the trial should produce a reliable result.

Some of the factors that can influence perception and reporting of pain include:

Endorphins: A higher level of endorphins in the system can increase the patient’s tolerance of pain
Mental state: Hunger, fatigue, stress and fear can all alter a patient’s mental state and contributeto altered perception of pain
Personal factors: A person who has dealt with chronic pain for a longer period of time may develop an increased tolerance
Other factors: Cultural factors, family factors and age can influence a patient’s perception of pain

Improving the Analysis of Crossover Trial Results for Chronic Pain Sufferers

Although a crossover trial design has the potential to produce very accurate results in determining the effectiveness of chronic pain treatments, we have found that inadequate statistical analysis can reduce the accuracy of the results produced. We have compiled analyses of multiple clinical trials that attempted to determine the effectiveness of the same treatment for chronic pain. We have found that more than two out of every three chronic pain studies using the crossover design fail to analyze the statistics gathered in a way that produces a reliable result.

We believe that learning how to interpret the results of crossover trials can benefit medicine as a whole. Standardized interpretation of crossover trials makes it possible to create larger reports compiling the results from several crossover trials. With larger sample sizes, the information collected becomes much more reliable. However, the trial data can only improve patient treatment plans with adequate assessment of the data from the initial trials.


In this instance, an athlete was originally diagnosed with minor quadriceps muscle strain and was treated for four weeks, with unsatisfactory results. When he came to our clinic, the muscle was not healing, and the patients’ muscle tissue had already begun to atrophy.

Upon examination using MSUS, we discovered that he had a full muscle thickness tear that had been overlooked by his previous provider. To mitigate damage and promote healing, surgery should have been performed immediately after the injury occurred. Because of misdiagnosis and inappropriate treatment, the patient now has permanent damage that cannot be corrected.

The most important advantage of Ultrasound over MRI imaging is its ability to zero in on the symptomatic region and obtain imaging, with active participation and feedback from the patient. Using dynamic MSUS, we can see what happens when patients contract their muscles, something that cannot be done with MRI. From a diagnostic perspective, this interaction is invaluable.

Dynamic ultrasonography examination demonstrating
the full thickness tear and already occurring muscle atrophy
due to misdiagnosis and not referring the patient
to proper diagnostic workup

Demonstration of how very small muscle defect is made and revealed
to be a complete tear with muscle contraction
under diagnostic sonography (not possible with MRI)


Complete tear of rectus femoris
with large hematoma (blood)


Separation of muscle ends due to tear elicited
on dynamic sonography examination

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