Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy

The medical management of people living with the Human Immunodeficiency Virus that
ultimately leads to the development of Acquired Immunodeficiency Syndrome has progressed
dramatically since the beginning of the pandemic in the early 1980's. Despite advances in
management and prevention, it is estimated that 33 million people worldwide are infected
with this virus. Of those, 1.1 million people living with HIV/AIDS reside in the United
States, while 56,000 new cases are added to this total every year. Medical providers are
challenged to achieve a delicate balance between offering effective anti-retroviral
therapeutic interventions while monitoring undesired side effects in an aging population of
"People Living with HIV/AIDS" (PLWA). Indeed, the life expectancy of PLWA has continued to
increase in the industrialized world, approaching parity with non-infected individuals.

Pain and sleep disturbances are commonly associated with chronic systemic diseases such as
fibromyalgia, arthritis, chronic liver disease and HIV/AIDS. Data collected from a cohort of
317 PLWA, indicate that 55% of them experienced and ranked increases in pain and sleep
disturbances among the top four symptoms associated with living with HIV/AIDS. Pain and
sleep disturbances were only preceded in reported prevalence by self-reported fatigue and
drowsiness. A review of systemic diseases' impact on sleep, suggests that alterations in
rapid eye movement (REM), non-REM sleep stages, as well as an increase in sleep disturbances
are associated with HIV disease progression into AIDS; moreover, 26% of the variance in
sleep disturbances experienced by PLWA in that study was attributed to pain and other
psychosocial factors.

Peripheral neuropathy (PN) is among the most common complications associated with long-term
survival with HIV/AIDS. It is estimated that 30-60% of all PLWA will develop PN at some
point during the course of the disease, with an increased prevalence seen in this patient
population as the disease progresses from HIV into AIDS. Functional impairments have also
been reported in the presence of neuropathies. Different authors have reported significant
differences in gait quality, walking speed and total distance walked in individuals with
damage to the peripheral nervous system. Despite advances in medical management of HIV
infection, the direct impact of commonly experienced symptoms associated with living with
HIV/AIDS, such as pain and sleep disturbances in the current era of anti-retroviral therapy
has not been extensively reported in the literature.

In a recent pilot study, conducted by this author and colleagues, the use of night time
lower extremity (LE) splinting showed promising results in the management of pain and sleep
disturbances. This pilot study design was a crossover study that included 22 PLWA with PN
and evaluated the effects of a three-week bilateral lower splints application on pain and
sleep. A 20% improvement in both pain and sleep scores was reported in this pilot study.
Additionally, a moderate effect size for pain and sleep scores was found. The results
suggested that the analgesic effect of the splint application persisted for a period of
several weeks following discontinuation of the lower splint application. These results were
obtained using a relatively small sample of patients and without a long-term follow-up
post-splinting application. Finally, that study could not determine whether the source of
the pain inhibition was due to the application of a full contact protective sheath on the
lower leg or the short-term immobilization at the ankle joints provided by the splints.

Purpose and Hypotheses

Therefore, the purpose and primary aim of this study is to evaluate the management of pain
and sleep disturbances in people living with HIV/AIDS-related PN with the use of bilateral
LE splints versus a control/placebo intervention of bilateral LE splint liner application.
The null hypotheses for the primary aim are:

- There is no difference in pain and sleep scores between the bilateral LE splints and
those obtained using the splint liners only following a three and six-week application.

- There is no difference in pain and sleep scores between baseline and following a
six-week LE splint application.

The secondary aim is to identify factors influencing function, as measured by the functional
reach test and the six-minute walk test; and their relationship with pain and sleep
disturbances in the presence of HIV/AIDS related neuropathy.

Inclusion Criteria:

- Adult PLWA 18 and older, with a clinical diagnosis of symptomatic bilateral LE PN
will be invited to participate.

- The participants will be on a stable pain and HIV/AIDS management regimen without
foreseeable alterations or changes to said pharmacological regimen, which may include
pain and or sleep medications.

- The participants will be community dwelling individuals, able to walk at or above a
modified independence level with or without the need of an assistive device to
ambulate, such as a cane or walker.

- Eligible participants will report at least one of the following clinical symptoms:
paresthesia, dysesthesia, and report night cramps in the LE

Exclusion Criteria:

- Participants will be excluded if they have a clinical diagnosis of any of the
following: significant cardiovascular or pulmonary disease (specifically, myocardial
infarction within the past six months, angina, or dyspnea at rest), paraplegia,
hemiplegia, other major neurological dysfunction, diabetes, absent pedal pulse during
examination, sleep apnea, or are pregnant.

- Additionally, patients unable to read English, patients with changes to their
pharmacological management during the study and or using any mechanical devices to
assist in normalizing sleep will be excluded from this study.