WHAT IS THE PURPOSE OF THIS STUDY? The investigators want to know if wearing a pair of
splints at night works to bring the pain down and help you sleep better (in people living
with HIV/AIDS related neuropathy).
HOW MANY PEOPLE WILL PARTICIPATE? About 58 to 88 people will take part in this study at the
Harris County Hospital District (HCHD).
WHAT WILL HAPPEN DURING THIS STUDY? As a participant, you will be assigned to one of two
treatment groups. In one group, you will be asked to wear leg splints at night and the other
you will wear the liners of the splints only.
You will be asked to answer questions about how well you sleep, how long you sleep, and
about your discomfort at the legs. The researcher will be there to help, but the
investigators want you to answer the questions on your own if you can. You will be asked to
reach forwards standing next to a wall and to walk for 6 minutes after that. The tests will
de done in random order. The sessions will be done at the beginning, at week three and week
six. You should finish all of the testing and questionnaires in an hour or less, for a total
of three hours over six weeks in the investigators clinic.
You will receive instructions on how to use the splints with liners or the liners alone at
home. You will be asked to wear them at night only for the next 6 weeks. Finally, the
principal investigator will contact you weekly by phone, to discuss issues of comfort and
your ability to adhere to the instructions provided.
||Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
- 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.