For the current study the primary outcome was the prevalence of pain at time of healing. Prevalence was defined as the percent of participants with pain at time of
healing. The secondary outcome was the incidence of pain at time of healing. Incidence was defined as the percent of participants with pain at time of healing of those who
were free of pain at treatment initiation. Pain specific to the leg ulcer was assessed using the short form McGill Pain Questionnaire (SF-MPQ) [30-32]. The McGill Pain
Questionnaire consists of 15 pain descriptors (11 sensory and 4 affective), a visual analogue scale (VAS), and the Present Pain Intensity (PPI). Each pain descriptor can be
valued either as “0=none”, “1=mild”, “2=moderate”, or “3=severe”. For the purposes of the analysis values 1 through 3 were recoded as “1-3=present” versus “0=not
present”. From the descriptors, sensory, affective, and total pain index scores were generated and standardized out of 100. The VAS is a 100mm scale anchored with “0=no
pain” and “10=worst possible pain”. Due to the highly skewed nature of the VAS score, pain was classified in two ways: i) present (VAS>0/10) or absent (VAS = 0); and ii)
none/mild (VAS≤3/10) or moderate/severe (VAS>3/10). The PPI is comprised of six number-word combinations ranging from “0=no pain” to “5=excruciating pain”. The
SF-MPQ is designed to assess the multidimensional nature of the pain experience and has been demonstrated to be a reliable, valid, and consistent measurement tool
[31]. Importantly, it has been used in studies of individuals with leg ulcers and other chronic wounds and found to be a sound approach for clinically assessing the quality of
pain with this population [15].
For the current study the primary outcome was the prevalence of pain at time of healing. Prevalence was defined as the percent of participants with pain at time of
healing. The secondary outcome was the incidence of pain at time of healing. Incidence was defined as the percent of participants with pain at time of healing of those who
were free of pain at treatment initiation. Pain specific to the leg ulcer was assessed using the short form McGill Pain Questionnaire (SF-MPQ) [30-32]. The McGill Pain
Questionnaire consists of 15 pain descriptors (11 sensory and 4 affective), a visual analogue scale (VAS), and the Present Pain Intensity (PPI). Each pain descriptor can be
valued either as “0=none”, “1=mild”, “2=moderate”, or “3=severe”. For the purposes of the analysis values 1 through 3 were recoded as “1-3=present” versus “0=not
present”. From the descriptors, sensory, affective, and total pain index scores were generated and standardized out of 100. The VAS is a 100mm scale anchored with “0=no
pain” and “10=worst possible pain”. Due to the highly skewed nature of the VAS score, pain was classified in two ways: i) present (VAS>0/10) or absent (VAS = 0); and ii)
none/mild (VAS≤3/10) or moderate/severe (VAS>3/10). The PPI is comprised of six number-word combinations ranging from “0=no pain” to “5=excruciating pain”. The
SF-MPQ is designed to assess the multidimensional nature of the pain experience and has been demonstrated to be a reliable, valid, and consistent measurement tool
[31]. Importantly, it has been used in studies of individuals with leg ulcers and other chronic wounds and found to be a sound approach for clinically assessing the quality of
pain with this population [15].
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