Status:
COMPLETED
Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy
Lead Sponsor:
Texas Woman's University
Collaborating Sponsors:
Harris County Hospital District
DJO Incorporated
Conditions:
HIV
AIDS
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 n...
Detailed Description
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 begin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01419314
Start Date
August 1 2011
End Date
June 1 2012
Last Update
January 3 2013
Active Locations (1)
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1
Thomas Street Health Center-HCHD
Houston, Texas, United States, 77009