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NCT01419314 · ClinicalTrials.gov registry record · NA
Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy
A NA study of Pain and HIV, sponsored by Texas Woman's University.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT01419314: Completed NA study of Pain and HIV, sponsored by Texas Woman's University.
NCT01419314 is a NA study of Pain and HIV that has completed, run by Texas Woman's University. The registered enrollment target is 46 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01419314, a NA study of Pain and HIV, has completed, sponsored by Texas Woman's University.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.
Conditions Studied
Interventions
- DEVICE Splinting application to the lower extremities
- DEVICE Splint liner application
Study Locations (1)
Texas
- Thomas Street Health Center-HCHD - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-06 |
| Phase | NA |
What the finished NCT01419314 record still lists
NCT01419314 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (85% lower).
The record links to 5 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Splinting application to the lower extremities is the first listed.
NCT01419314 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01419314 about?
NCT01419314 is a clinical study titled "Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy". 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...
What is the current status of trial NCT01419314?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2011-08. Estimated completion is 2012-06.
What conditions does trial NCT01419314 study?
This clinical trial studies the following conditions: Pain, HIV, Sleep, Peripheral Neuropathy, AIDS.
What interventions are being tested in trial NCT01419314?
The interventions under investigation include: Splinting application to the lower extremities (DEVICE), Splint liner application (DEVICE).
Who is sponsoring clinical trial NCT01419314?
This trial is sponsored by Texas Woman's University, which has 51 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01419314 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01419314's enrollment target sits among peer trials
46 268th of 374 higher than 104 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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