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Clinical Trial
. 2011 Mar 25;9:17.
doi: 10.1186/1477-7525-9-17.

Relationships Between Changes in Pain Severity and Other Patient-Reported Outcomes: An Analysis in Patients With Posttraumatic Peripheral Neuropathic Pain

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Free PMC article
Clinical Trial

Relationships Between Changes in Pain Severity and Other Patient-Reported Outcomes: An Analysis in Patients With Posttraumatic Peripheral Neuropathic Pain

Robert van Seventer et al. Health Qual Life Outcomes. .
Free PMC article

Abstract

Background: 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.

Methods: This 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).

Results: Change 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.

Conclusions: Overall, 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).

Figures

Figure 1
Figure 1
Predicted relationship between change in pain severity and mean change in severity of patient-reported sleep disruption. Relationship between change in pain severity and change in severity of patient-reported sleep disruption based on the Medical Outcomes Study-Sleep Scale (MOS-SS) 9-item Sleep Problems Index (A), MOS-SS Sleep Disturbance subscale (B), and sleep interference on a 0-to-10 numeric rating scale (C). Analysis based on the total sample of all available patients. P <.001 for the overall relationship.
Figure 2
Figure 2
Predicted relationship between change in pain severity and mean change in pain interference on daily function. Relationship between change in pain severity and change in pain interference on daily function assessed using the modified Brief Pain Inventory-short form (mBPI-sf) Pain Interference Index. Analysis based on the total sample of all available patients. P <.001 for the overall relationship.
Figure 3
Figure 3
Predicted relationship between change in pain severity and mean changes in anxiety and depression. Relationship between change in pain severity and mood based on the anxiety (A) and depression (B) subscales of the Hospital Anxiety and Depression Scale (HADS). Analysis based on the total sample of all available patients. P <.001 for the overall relationship

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