Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV AIDS Peripheral Neuropathy Pain Sleep |
Device: Splinting application to the lower extremities Device: Splint liner application |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy |
- Pain Scores at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]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.
- Pain Scores [ Time Frame: Week 6 ] [ Designated as safety issue: No ]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.
- Sleep Quality/Quantity Scores (PSQI) [ Time Frame: week 3 ] [ Designated as safety issue: No ]The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions.
- Sleep Quality/Quantity Scores (PSQI) [ Time Frame: week 6 ] [ Designated as safety issue: No ]The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions. Buysse et al. reported sensitivity and specificity values of 89.6% and 86.5%, respectively for this scale in identifying good and poor sleepers.
- Function-Reach [ Time Frame: week 3 ] [ Designated as safety issue: No ]
Forward reach test
For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed "to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor". The average distance of three reaching attempts was recorded and used in the analysis.
- Function-Reach [ Time Frame: week 6 ] [ Designated as safety issue: No ]
Forward reach test
For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed "to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor". The average distance of three reaching attempts was recorded and used in the analysis.
- Function-Walking Distance [ Time Frame: week 3 ] [ Designated as safety issue: No ]
Six minute walk test
For this test the participants were instructed to: "Please walk as far, as fast and as safe as you can for up to six minutes". The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor.
- Function-Walking Distance [ Time Frame: week 6 ] [ Designated as safety issue: No ]
Six minute walk test
For this test the participants were instructed to: "Please walk as far, as fast and as safe as you can for up to six minutes". The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor.
| Enrollment: | 46 |
| Study Start Date: | August 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Splinting application
Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
|
Device: Splinting application to the lower extremities
Walkabout™ splints (Don Joy Orthopedics, Vista, CA, USA) will used in the splinting treatment. The Walkabout splint is a one-piece injection molded walking boot fitted with a rocker bottom allowing for ambulation. The participants will be fitted and instructed to wear the bilateral LE splints to sleep for the duration of the study (6 weeks).
Other Name: Walkabout splint
|
|
Placebo Comparator: Splint liner application
The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study.
|
Device: Splint liner application
The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study (6 weeks).
Other Name: Walkabout liner
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Texas | |
| Thomas Street Health Center-HCHD | |
| Houston, Texas, United States, 77009 | |
| Principal Investigator: | Robert Sandoval, MS, PT | Texas Woman's University |
More Information
Publications:
| Responsible Party: | Robert Sandoval, Principal Investigator, Texas Woman's University |
| ClinicalTrials.gov Identifier: | NCT01419314 History of Changes |
| Other Study ID Numbers: | 16196 |
| Study First Received: | August 10, 2011 |
| Results First Received: | September 13, 2012 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Texas Woman's University:
|
Physical Therapy Splint Sleep Pain |
6 min walk forward reach Function |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome Peripheral Nervous System Diseases Sleep Disorders Dyssomnias Parasomnias Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes HIV Infections Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Neuromuscular Diseases Nervous System Diseases Signs and Symptoms Mental Disorders Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 23, 2013