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New Pain Assessment Tool for Chronic Low Back Pain

August 13, 2018
Mixed-method approach may guide clinicians toward more appropriate, individualized treatment

with Mona Martin, RN, MPA, Michael E. Geisser, PhD, Rainer Freynhagen, MD, Jeffrey Fudin, PharmD, and Tiziano Marovino, DPT, MPH

Introducing PAL-S

A new pain assessment tool that uses a patient-reported outcome measure could be used in the future to manage chronic low back pain. While most patient-reported tools assess pain across different pain conditions, the Patient Assessment for Low Back Pain-Syndrome (PAL-S) is a bit different. The developers used qualitative input from individuals suffering from chronic low back pain as part of their design process for the instrument.1

“The mixed methods approach taken in developing the PAL-S more than meets the FDA recommendations for early stages of PRO development,” said Mona Martin, RN, MPA, executive director of Health Research Associates (Mountlake Terrace, WA), the outcomes research company that led the development of PAL-S. “Work has been completed now to evaluate the measurement properties in a patient treatment setting, and we hope to see those results published later this year.”

The outcome measure has demonstrated content validity, including test-retest validity and concurrent validity, said Michael E. Geisser, PhD, professor of rehabilitation psychology and neuropsychology at the University of Michigan, in an accompanying editorial.2 “A disease-specific measure like this may more accurately reflect both the amount and type of pain that a person has,” said Dr. Geisser. “You could use a measure like this to look at what possible subtypes of low back pain a person has. And if you could pick up the specific type, this could potentially be beneficial.” For musculoskeletal pain, for instance, physical therapy may be more helpful, Geisser said. For patients with a different type of chronic low back pain, a medication may be more beneficial.

How PAL-S May Improve Back Pain Therapy

The PAL-S contains 14 items that patients can use to describe their symptoms, including:

  • aching
  • burning
  • muscle spasms
  • overall pain 
  • prickling
  • radiating
  • sensitive
  • sharp
  • shocking
  • shooting
  • squeezing
  • stiffness
  • tender
  • throbbing.

“The [symptoms] are all rated at a NRS (numeric rating scale) from 0 to 10,” explained study co-author Rainer Freynhagen, DEAA, chair of the department of anesthesiology, critical care medicine, pain medicine and palliative care at the Pain Center Lake Starnberg, Benedictus Hospital in Tutzing, Germany. “This makes it much more clear as to what exactly is going on in comparison to other questionnaires.”

Jeffrey Fudin, PharmD, clinical pharmacy specialist in pain management at the Stratton VA Medical Center in Albany, New York, and PPM’s Co-Editor-at-Large, described what makes the PAL-S unique. “There are no other questionnaires that are specific to chronic back pain and that is what makes this different. It’s better because it is more specific,” he said. “Other types of tools ask about the quality and quantity of pain in general but there are so many kinds of pain, it is hard to narrow it down.” Unlike a general tool, PAL-S narrows down back pain only. “If you know what you are dealing with, like an acute flare-up of back pain that the patient is rating an 8 out of 10 on a scale of 1 to 10, it is easier to deal with and you may prescribe different medications,” Dr. Fudin said. “This tool can help the clinician guide therapy.”

The PAL-S could be useful in today’s world of “managed care,” in particular, added Dr. Fudin. “Managed care is all about looking for practical assessments and actionable outcome,” he said. “[This tool] could help select the appropriate therapy based on pain type and how a patient’s pain is measured. To have a tool specific to low back pain is, in my mind, huge.” He adds that this tool “gets to the crux of the pain and specifically outlines the qualitative nature of the pain within the medical record. This really specifically outlines the kind of symptoms the patient experiences.”

The Future of PAL-S—From Clinical Trials to Treatment Plans

While the measure is not currently approved for use, it could have an impact on clinical trials soon, Dr. Freynhagen said. “While a tool like this ultimately will not help patients manage their pain, it will help the industry, researchers, and physicians to develop better answers and better drugs” for chronic back pain. Added Dr. Geisser, “It is essential that researchers also consider assessing other patient-centered outcomes such as pain interference and functional ability,” when treating back pain conditions.

Given the research to date, “We only have test-retest reliability and validity that has been reported by the authors,” explained Tiziano Marovino, DPT, MPH, senior vice president of Health Strategy and Innovation at Biogenesis Group, LLC in Ypsilanti, Michigan, and PPM editorial board member. “More data is needed, specifically addressing sensitivity or responsiveness, which tells us a test’s ability to detect clinically significant levels of change.” He added that, “This also means we have to also identify what a minimal clinically important difference (MCID) actually is using this new measure. When these metrics are better defined, we will be in a better position to comment on the utility of this novel measure.”

Last updated on: August 16, 2018
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