We feel your pain: the challenge of measuring pain in Clinical Trials

Illustration of a pain scale

Why is pain challenging to measure?

Considered an alarm in the brain that a potentially harmful stimuli has caused damage to the body, pain is a sensation that differs from person to person at different times and under different circumstances and for different indications. 

Because pain is subjective, it is not a simple symptom to understand or describe.  

Useful characterization of pain depends on many factors: severity, duration, location on body (including internal and external), distribution and concentration of sensory nerves, and pain “quality” – which can be described using a wide range of numbering systems, specific words, visual scales, colors, images, or drawings. 

Why is pain important to recognize and measure?

Because pain is a symptom of many diseases and conditions, it’s an important symptom to understand. To improve our understanding of pain, we need to improve how we measure it. With many debilitating characteristics, pain can have a negative impact on a person’s quality of life due to its physical, emotional, social and cognitive effects. Short and long term effects on quality of life may include the inability to work or maintain employment, isolation from social interaction (which can contribute to depression), and a negative impact on a person’s overall health and behavior.

Understanding the different characteristics of pain can reveal clues that signal what is causing it. Measuring pain is an important exercise needed to understand the root causes and ultimately determine effective treatments for patients.

Example of pain - clinical trial pain measurement and rating scales

Example of pain - clinical trial pain measurement and rating scales

How does IVRCC’s technology measure pain?

  • IVRCC’s application design, including implementation of questionnaires and e-diaries, efficiently and accurately captures the varied characteristics of pain symptoms.
  • IVRCC’s data collection technology captures and documents timely and accurate outcome responses from subjects, caregivers, and clinical personnel confidentially and securely.  
  • Collecting specific medication-treatment diary points in real-time during a clinical trial can also help diagnose the cause of pain and lead toward solutions to mitigate it. 
  • Many instruments are validated to address specific indications, while other general surveys may apply in multiple indications. 
  • General survey instruments can be used to measure pain in a range of therapeutic areas and indications, both for quantitative and qualitative results.

How is Pain Rated?

Extensive research has been conducted to develop validated and novel instruments to measure pain. In choosing a pain scale, the characteristics of the therapeutic areas, characteristics of the patient population, and cultural and language differences would be considered.

  • Quantitative: How bad pain is the pain? How bad is the pain at designated times? Pain can be ranked from none to worst, using a varied range of descriptive words, numbers, pictures, colors, locations and/or combinations of suc, e.g., moderate, mild, severe, worst possible; 3 on a scale of 0-4, or 0-10, a worst pain 10 with a crying face image, or the color red representing the worst pain.
  • Qualitative: What does the pain feel like? Some examples include dull, sharp, throbbing, stinging, tingling, burning, or stiffness and many more depending on specific indications.
  • Absolute pain and Relative Pain: 0-10 range scales for determination of severity and for changes in pain. 
  • Visual Analog Scales (VAS): Originally a paper printed and labeled with “No Pain” on the left end and “Worst Pain” on the right end, where the subject/patient marks on the line to indicate the severity that matches their pain. 
  • Numerical Rating Scales (NRS): Can be used to rate pain with numbers, commonly 0-10 for scales marked “No pain” to “Worst possible” at the ends and in between are numbers and descriptive words. Other ranges and/or descriptive words may be added for different disease indications. Many researchers believe that a range of 0-4 or 0-5 may be less confusing and more than adequate for ranking most ranges.
  • Categorical Scales: Using words, possibly along with numbers, colors, pictures, and/or locations on the body, with other scales. The goal is to characterize pain symptoms as clearly and easily as possible for patients and caregivers. 
  • Clinical Global Impression (CGI): Most commonly used by clinicians to rate pain severity, and global improvement or a change between two time points, while also observing visual cues from patients during the interview. 
    • Patient Global Impression (PGI): A patient self-reported evaluation gauging global improvement or a change between timepoints. 
  • Wong-Baker FACES: Graphic depictions of six faces on a 0-10 scale, gradually changing from happy to sad, commonly used for children over 3 and for adults. 
  • Drawings: Allow both clinicians and self-reporting patients to identify where they are experiencing pain in their body with what severity, and whether it is internal and/or external.  
  • A McGill Pain Index: An extensive scale that uses 78 words to describe pain. Within 20 groups of 3-6 words each, the scale is meant to help patients describe their pain with precise detail.
  • Other Pain scales: Designed for people who can’t describe or rate their own pain, for example, very young, or very old individuals who cannot communicate due to language barriers, disabilities, or certain medical conditions. 
  • A healthcare provider’s observations of a patient’s facial expressions, body language, agitation, or inability to be comforted, etc. can help determine pain ratings using specialized survey instruments for those who cannot relay information about the pain they are feeling. 
  • Examples of other categorical scales are FLACC Pain, CRIES Pain, COMFORT Pain, (CAS) Color Analog Scale, Mankioski Pain, (BPI) Brief Pain Inventory, (DDS-I) Descriptor Differential Scale of Pain Intensity, (DVPRS) Defense and Veterans Pain Rating Scale, WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis, Patient Interpretation of Neuropathy (PIN), Neuropathic Pain Symptom Inventory (NPSI). 
  • Novel Custom scales, surveys and questionnaires for specific indications and circumstances. 

IVRCC’s Application Features for Pain Data Collection 

Pain Measurement Technology for Clinical Trials

Validated instrument for use in an oncology study

  • Approved and validated. Per FDA guidance, IVRCC presents true-to-paper replications of validated questionnaires and diaries, allowing easy access for subjects, including pain scales for oncology QoL, CNS indications, gastroenterology, dermatology, allergy, women’s studies and more. Patient facing questions and diaries presented to subjects are approved by regulatory bodies.
  • Real-time guidance. Online training, instructions and pop-ups are incorporated throughout the user experience.
  • Bring your own device (BYOD). The ability to bring or choose your own device improves consistency and compliance. Electronic pain questions and scales are navigable through easy-to-use interactive web links, text messaging, native apps when needed, and through interactive voice response systems in certain situations. 
  • Easy self-reporting. Allowing patients to self-report the pain location eliminates confusion and the burden of having to use descriptive words. Our electronic systems guide subjects, using a touch screen, to select points on body diagrams. 
  • Consistency across devices. The pain scale questionnaires and diaries that IVRCC translates to web-based applications are automatically compatible and consistent across devices, improving convenience for subjects and increasing subject engagement. 
  • Custom reminders. Reminders can be configured and scheduled on any time interval, and can be modified and specified according to arm, cohort, visit, and more, ensuring effective patient engagement and collection of data per protocol. IVRCC’s systems adapt reminders to accommodate new activities whenever the subject is required to enter self-reported pain ratings, such as after a treatment. If a subject misses a datapoint, the system sends reminders.
  • Flexible features for subjects. Questionnaires and ediaries are specifically configured for treatment arm, for every study and visit, with the ability to return to unanswered questions as needed so subjects are clear when and what they need to answer during a given session or visit.
  • Easy self-registration. Subjects securely self-register to the system with their confidential information. After eligibility is confirmed, a subject ID is generated by site personnel. Self-registration ensures confidential, secure and private data collection for the highest quality data integrity. 
  • Controlled data access. Stakeholders have controlled access to any data that the IVRCC system collects, and data is seamlessly integrated between electronic systems. IVRCC is expert at reporting, tracking, and storing system data. Our database experts provide clients with datasets to aid key decision making throughout the course of the study.
  • Roles and permissions. IVRCC offers extensive control of permissions for users and subjects to access only certain systems and data

IVRCC’s Application Benefits for Pain Data Collection 

Pain Measurement Technology for Clinical Trials

ediary for a Complex Regional Pain Syndrome (CRPS) study

  • IVRCC’s wide experience. Our experience with pain ePRO and ediaries in many therapeutic areas and sub-indications allows us to tailor and optimize application design features for subjects, patients, caretakers, clinicians and other roles. 
  • Data adheres to A-L-C-O-A. Because IVRCC designs and builds applications to clinical e-source data collection standards, pain data collected adheres to A-L-C-O-A (Attributable, Legible, Contemporaneous, Original, and Accurate), regulatory, security and confidentiality requirements.
  • Easy-to-use digital display. VAS Visual Analog scale is displayed on tablets or smartphones so patients can indicate the matching location of their pain. Our electronic system automatically calculates the numerical location and has the option to display or not display in real-time, thus reducing the need for multiple raters.
  • Easily exportable data. High-quality pain datasets are exportable and specifically designed for efficacy analysis and evaluation. 
  • High subject compliance. Because of easy-to-use visual presentation of ediaries and questionnaires, patients maintain high levels of compliance.
  • Flexible scheduling and communication. ePRO and ediary questionnaires are scheduled at certain timepoints designated by protocol and/or preference. Automated reminders and notifications alert study personnel and subjects when non-compliant behavior is detected.  
  • High level of deviation control. Throughout study only valid data can be entered.
  • Custom, configurable, and agile. We quickly build and deploy applications that collect high quality pain data.

Visual Analog Scale for Pain Measurement in Clinical Trials - IVRCC

Why Work with IVRCC for Pain Data Collection?

IVRCC is an experienced and collaborative partner. IVRCC’s decades of design experience and our collaborative approach result in quality surveys that yield high compliance from subjects. When creating novel web based and voice questionnaires and diaries, IVRCC works closely with clients to ensure ease-of-use and high-value relevance. 

IVRCC may recommend our alternate modalities to collect quality data and achieve high compliance in challenging situations, such as where there is no internet connection,  e.g., a hospital OR where voice telephone would be accessible and more reliable.

Case Study: Detecting Pain During a Hemophilia Treatment Clinical Trial

This study was designed to investigate and monitor the effects on efficacy and safety of systemic administration of experimental gene therapy treatment of adult patients with severe or moderately severe hemophilia B and severe bleeding type.

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“We often hear that our clients appreciate the high level of customization we offer, our attention to detail, and how we make data collection a very positive experience for them.”

Nancy Hudak - IVRCC

Nancy Hudak
Business Development Analyst

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