Virtual Clinical Trials in Chronic Pain

 

Chronic pain is defined as a long lasting pain (at least 12 weeks), that persists after the resolution of what caused pain initially. Chronic back pain in particular, is one of the most common reasons people see a doctor or miss days at work. Treatment for chronic pain is not always successful and there is still a high medical need for this condition.

Healint’s raison d’être is to help people who suffer to find a solution and get better. One way to achieve this goal is to accelerate clinical trials that can bring new products to the market. A large proportion of our 3 millions users are struggling with chronic pain and many would be ready to participate in a trial that would bring them a new hope.

We can accelerate the conduction of clinical studies at every stage:

  1. Recruitment: we can reach out to our community to promote participation in a trial

  2. Study conduction: we use neuroscience-based tools to keep participants motivated until the end of the study to reduce drop out rate

  3. Query resolution: we avoid 90% of the mistakes, at input with logic-checks and edit-checks and we resolve the remaining 10% within a couple of days. The query time at the end of the study is almost zero.

In chronic pain, we run the most popular scales that assess symptoms and outcome in trials. They can be about pain level itself (very basic NRS or VAS), but also on consequences of quality of life, sleep and disability. We also have the expertise to help you in the choice of the scales to use, on the study design and on the data analysis to best fit your objectives.

 

Pain NRS

(PRO)

The Pain Numerical Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It has been shown that a composite scoring system including best, worse, and current level of pain over the last 24 hours was sufficient to pick up changes in pain intensity with maximal reliability.

 
 

Pain VAS

(PRO)

The pain intensity is assessed with this Visual Analog Scale ranging from 0 to 100, where 0 represents no pain and 100 represents the worst pain imaginable. It can be analyzed longitudinally, or in groups. It can cover different recall periods (current, over the last 24h, or more). It can be analyzed as change vs baseline, as compared between groups, as number of responders (with a predefined threshold), etc… The main advantage of this scale vs an ordinal scale is that it is more sensitive to small changes.

 
 

BPI-SF

(PRO)

The Brief Pain Inventory - Short Form, is a 9-item stand-alone questionnaire used to assess a patient’s severity of pain and the impact of that pain on the patient’s daily activities. The patient is asked to rate their average, worst, minimum, and current pain intensity, list the patient's treatments and their perceived effectiveness, assess the extent to which the pain is interfering with overall activities, mood, walking, normal work, relationships, sleep, and enjoyment of life on a 10-point scale.

 
 

EQ-5D-5L

(PRO)

EuroQoL 5D is a very popular Quality of Life scale is used in a large number of indications and all types of studies (observational, population health, clinical trial…) It can be used longitudinally or to compare groups. It assesses 5 dimensions of quality of life: Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression + an estimate of health level on a scale from 0 to 100. The evaluation is about the day when the questionnaire is completed. The results can be presented in various ways: as a description of health profile, as a measure of overall self-rated health status, or from an index value. We automate calculation and check live, the validity of the measures to ensure consistency