Impact of Low Back Pain on Quality of Life: Assessment by Patient Functionality Questionnaire and Treatment Results Using a Combination of Diclofenac plus B Vitamins or Diclofenac Monotherapy

Objective: To analyze the Patient Functionality Questionnaire (PFQ) scores of the patients treated with either Diclofenac + B vitamins (Group DB) or Diclofenac monotherapy (Group D) in order to better understand the impact of the combination of diclofenac with vitamins B1, B6, and B12 on quality of life. Research Design/Methods: We performed a post-hoc analysis of tabulated data generated during the DOLOR study (Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: the DOLOR study), using the software GraphPad Prism 5 for Windows, v5.04. The absolute number or percentage of “True”/“False” respondents for each questionnaire item at each study visit, together with the absolute number and percentage of subjects with no change, improvement, or worsening of each PFQ item at each study visit, within and between treatment groups were arranged on contingency tables and analyzed with the Chi-squared or Fisher’s Exact test. Results: At pretreatment there were no statistically significant differences between treatment groups (p > 0.05 for all items). At Visit 2 in both treatment groups, there were statistically significant improvements in individual question responses in each of the 12 items of the questionnaire (p < 0.05 for all items). At Visit 2, comparing the distribution of patients in each treatment group with “improvement”, “no change”, or “worsening”, there was a statistically significant superiority among subjects of group DB in response to items 1, 6, 8, and 10. At Visit 3, both groups had statistically significant (p < 0.001) improvements in each individual item of the PFQ in relation to pretreatment values. The distribution of subjects in each treatment group presenting with “improvement”, “no change”, or “worsening” at Visit 3 varied significantly in favor of group DB in the responses to item 4. At Visit 4, the subjects remaining in treatment in both groups showed statistically significant improvement in PFQ responses in relation to pretreatment values (p < 0.05). The distribution of subjects in each treatment group presenting with “improvement” or “no change” at Visit 4 varied significantly in favor of group D in the responses to items 5, 8, and 12. Conclusion: Improvement in overall PFQ scores was observed in both treatment groups, though the specific items of the questionnaire of the subjects in group DB at Visit 2 showed greater improvement in areas related to sleep quality, mobility, ability to wash and dry, ability to walk distances, and posture comfort. These results serve to corroborate the previously published data, which indicates a benefit of combining the B vitamins with diclofenac in the treatment of patients with low back pain, yielding shorter treatment time to resolution of the lumbago in the treated patients.