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

This study has been completed.
Sponsor:
Collaborators:
Harris County Hospital District
DJO Incorporated
Information provided by (Responsible Party):
Robert Sandoval, Texas Woman's University
ClinicalTrials.gov Identifier:
NCT01419314
First received: August 10, 2011
Last updated: December 5, 2012
Last verified: December 2012

August 10, 2011
December 5, 2012
August 2011
June 2012   (final data collection date for primary outcome measure)
  • 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.
  • Change in Pain [ Time Frame: week 0,3 and 6 ] [ Designated as safety issue: No ]
    A composite pain score will be collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the patient is asked to quantify the different aspects of the pain experience in the presence of neuropathies. Galer and Jensen reported that the NPS exhibits both predictive and discriminate validity as well as being sensitive to the effect of treatments impacting neuropathic pain. The aggregate NPS score obtained using the NPS will be computed and used in the data analysis.
  • Change in Sleep quality/quantity [ Time Frame: week 0,3 and 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.
Complete list of historical versions of study NCT01419314 on ClinicalTrials.gov Archive Site
  • 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.

  • Function-Reach [ Time Frame: week 0,3 and 6 ] [ Designated as safety issue: No ]

    Forward reach test

    For this test, the investigators will ask 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 will be 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 will be recorded and used in the analysis.

  • Function-Walking distance [ Time Frame: week 0,3 and 6 ] [ Designated as safety issue: No ]

    Six minute walk test

    For this test the participants will be 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 will be clearly marked with taped trapezoids to the non-skid floor.

Not Provided
Not Provided
 
Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy
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 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • HIV
  • AIDS
  • Peripheral Neuropathy
  • Pain
  • Sleep
  • 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
  • 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
  • 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.
    Intervention: Device: Splinting application to the lower extremities
  • 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.
    Intervention: Device: Splint liner application
Sandoval R, Runft B, Roddey T. Pilot study: does lower extremity night splinting assist in the management of painful peripheral neuropathy in the HIV/AIDS population? J Int Assoc Physicians AIDS Care (Chic). 2010 Nov-Dec;9(6):368-81. doi: 10.1177/1545109710373828. Epub 2010 Nov 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01419314
16196
No
Robert Sandoval, Texas Woman's University
Texas Woman's University
  • Harris County Hospital District
  • DJO Incorporated
Principal Investigator: Robert Sandoval, MS, PT Texas Woman's University
Texas Woman's University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP