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

This study has been completed.
Harris County Hospital District
DJO Incorporated
Information provided by (Responsible Party):
Robert Sandoval, Texas Woman's University
ClinicalTrials.gov Identifier:
First received: August 10, 2011
Last updated: December 5, 2012
Last verified: December 2012
Results First Received: September 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: HIV
Peripheral Neuropathy
Interventions: Device: Splinting application to the lower extremities
Device: Splint liner application

  Participant Flow

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
LE Splints Group Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
Splint Liner Application The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
Total Total of all reporting groups

Baseline Measures
    LE Splints Group     Splint Liner Application     Total  
Number of Participants  
[units: participants]
  23     22     45  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     23     22     45  
>=65 years     0     0     0  
[units: years]
Mean (Standard Deviation)
  50.65  (8.04)     46.09  (7.71)     48.42  (8.13)  
[units: participants]
Female     9     10     19  
Male     14     12     26  
Race/Ethnicity, Customized  
[units: participants]
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     12     12     24  
White     9     6     15  
Latino     2     3     5  
Unknown or Not Reported     0     0     0  
CD4 [1]
[units: cells/mm3]
Mean (Standard Deviation)
  586.13  (233.64)     446.09  (232.54)     517.67  (241.07)  
Log Viral load [2]
[units: Log (copies/ml)]
Log Mean (Standard Deviation)
  2.25  (1.08)     1.96  (0.75)     2.10  (0.93)  
Years living with HIV [3]
[units: years]
Mean (Standard Deviation)
  11.30  (6.01)     10.32  (7.62)     10.82  (6.79)  
Pain scores [4]
[units: Scores on a 0-100 scale.]
Mean (Standard Deviation)
  61.35  (20.98)     60.16  (14.35)     60.77  (17.85)  
Sleep Scores [5]
[units: Scores on a 0-21 scale]
Mean (Standard Deviation)
  14.13  (3.89)     15.14  (4.68)     14.62  (4.28)  
Function- Forward reach [6]
[units: Centimeters (cm)]
Mean (Standard Deviation)
  35.31  (6.45)     36.88  (8.36)     36.07  (7.37)  
Function-Walking Distance [7]
[units: Meters (m)]
Mean (Standard Deviation)
  246.00  (133.71)     241.89  (151.46)     243.99  (141.04)  
[1] The most recent CD4 cell counts were extracted from the medical record.
[2] The most recent measured HIV viral load (log viral load) was extracted from the medical record. Measured in viral copies/ml on a logarithmic scale with 1.48 log/ml representing undetectable viral load levels for the viral load test conducted in our site (less than 50 copies/ml)
[3] The number of years living with HIV was calculated by subtracting the year of diagnosis to the year of sutdy enrollment.
[4] Neuropathic Pain Scale (NPS) score, where a score of "0" equates to "no pain" and "100" is the maximum neuropathic pain score possible. The scale score is computed by totaling all 10 pain sub-scales, each individually scored from 0-10.
[5] Pittsburgh Sleep Quality Index (PSQI),this is a 0-21 score scale with 21/21 denoting maximum sleep disturbances. The PSQI is scored by adding all seven sub-scales, each with a maximum score of three. A score greater than 5/21 characterizes the individual as a "poor sleeper."
[6] The average of 3 reaching trials are reported. One participant in the liner group had extreme reaching values (>3 standard deviation from the mean) and was excluded from the report (n=22). Longer distances in this test represent better volitional control of balance in the sagittal plane. Reaching distances >30 cm are considered to be within normal limits.
[7] The 6 minute walk distance was collected on all participants. Longer walking distances represent decreased impact on function. Non-HIV cohorts typically are able to walk 400-600m in six-minutes.

  Outcome Measures
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1.  Primary:   Pain Scores at Week 3   [ Time Frame: Week 3 ]

2.  Primary:   Pain Scores   [ Time Frame: Week 6 ]

3.  Primary:   Sleep Quality/Quantity Scores (PSQI)   [ Time Frame: week 3 ]

4.  Primary:   Sleep Quality/Quantity Scores (PSQI)   [ Time Frame: week 6 ]

5.  Secondary:   Function-Reach   [ Time Frame: week 3 ]

6.  Secondary:   Function-Reach   [ Time Frame: week 6 ]

7.  Secondary:   Function-Walking Distance   [ Time Frame: week 3 ]

8.  Secondary:   Function-Walking Distance   [ Time Frame: week 6 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The contrast between the splinting group and liner group was statistically underpowered. The data was collected and analyzed by the primary investigator. The clinical diagnosis of peripheral neuropathy was not confirmed with EMG or punch skin biopsy.

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