Abstract
BackgroundThe objective of this study is to use the pain numeric rating scale (NRS) to evaluate associations between change in pain severity and changes in sleep, function, and mood assessed via patient-reported outcomes (PROs) in patients with posttraumatic pain.MethodsThis is a secondary analysis of a clinical trial evaluating pregabalin in patients with posttraumatic peripheral neuropathic pain (N = 254). Regression models were used to determine associations between changes in pain (0-10 NRS) as the predictor and scores on the following PRO measures as the outcome: Pain Interference Index; Hospital Anxiety and Depression Scale anxiety and depression subscales; Medical Outcomes Study-Sleep Scale 9-item Sleep Problems Index and Sleep Disturbance subscale; and Daily Sleep Interference Scale (0-10 NRS).ResultsChange in pain severity showed clear, direct relationships with changes in function, anxiety, depression, and sleep PROs, all of which were statistically significant (P <.001). Results from subgroup analyses (≥30% or ≥50% pain responders, pregabalin or placebo treatment, age ≤ 51 years or > 51 years) tended to be consistent with results from the overall sample.ConclusionsOverall, a direct relationship exists between pain and various aspects of patient's well-being and functioning, which can provide a quantitative assessment of how improvements in pain may be expected to relate to other patient outcomes. (http://ClinicalTrials.gov Identifier number NCT00292188; EudraCT #2005-003048-78).
Highlights
The objective of this study is to use the pain numeric rating scale (NRS) to evaluate associations between change in pain severity and changes in sleep, function, and mood assessed via patient-reported outcomes (PROs) in patients with posttraumatic pain
We evaluated the association between change in pain, assessed daily using a 0-to-10 NRS (0 = no pain, 10 = worst possible pain) and averaged to give a weekly result, and several other PROs assessed at baseline and end of double-blind treatment at week 8
In the original placebo-controlled clinical study [10], pregabalin was associated with a statistically significant improvement in pain compared to placebo, and significant improvements in other PRO scores that included pain-related sleep interference, the MOS sleep scale, and the anxiety and depression subscales of the Hospital Anxiety and Depression Scale (HADS)
Summary
The objective of this study is to use the pain numeric rating scale (NRS) to evaluate associations between change in pain severity and changes in sleep, function, and mood assessed via patient-reported outcomes (PROs) in patients with posttraumatic pain. The 11-point numeric rating scale (NRS), which ranges from 0 (no pain) to 10 (worst possible pain), has become one of the most frequently used instruments for evaluating pain based on its simplicity and ease of comprehension by patients. This NRS is recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) as one of the core outcomes for assessment in clinical trials of chronic pain [2]. Not included in the IMMPACT recommendations, sleep is another outcome that is affected adversely by pain, with consistent evidence endorsing this relationship [5,6,7]
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