Randomized Trial of Lower Extremity Splinting to Manage Neuropathic Pain and Sleep Disturbances in People Living with HIV/AIDS

Abstract

Background/Aims: Distal symmetrical peripheral neuropathy (DSPN) and sleep disturbances are among the most common complications reported in people living with the human immunodeficiency virus infection and acquired immunodeficiency syndrome (PLWHA). DSPN-pain is predominantly managed by using systemic agents with little evidence supporting their analgesic efficacy. The purpose of this study is to evaluate the effect of nighttime lower extremity splinting application on DSPN-related pain and sleep disturbances compared to a parallel splint liner application in PLWHA. Methods: Forty-six PLWHA and DSPN were randomized to nighttime wearing of bilateral lower extremity splints or the liners only. Pain and sleep outcomes were measured at baseline, week 3, and week 6. The pain was measured using the Neuropathic Pain Scale and sleep using the Pittsburgh Sleep Quality Index. Results: Pain and sleep scores improved in both groups over time. The median percentage pain reduction at week 6 was 8% in the liner group and 34% in the splint group. The change in pain scores in the splint group was found to be significant over time, P < .0005. The contrast between the splint and liner groups was underpowered (26%) and was not found to be significant, P > .05. Sleep scores improved 20% from baseline to the end of the study in both groups; all participants were classified as poor sleepers. Conclusion: The 6-week use of nighttime splints reduces DSPN-pain possibly by providing peripheral inhibition of external stimuli. Future studies are needed to validate this inhibitory intervention to manage DSPN in PLWHA and other neuropathic conditions.