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

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ClinicalTrials.gov Identifier: NCT01419314
Recruitment Status : Completed
First Posted : August 18, 2011
Results First Posted : January 3, 2013
Last Update Posted : January 3, 2013
Sponsor:
Collaborators:
Harris County Hospital District
DJO Incorporated
Information provided by (Responsible Party):
Robert Sandoval, Texas Woman's University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: HIV
AIDS
Peripheral Neuropathy
Pain
Sleep
Interventions: Device: Splinting application to the lower extremities
Device: Splint liner application

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The participants were randomized to use a night application of bilateral lower extremity splints (23 participants) or using the soft liners of the splints only (23 participants). One participant was excluded from the liner group as he failed to disclose a recent diabetes diagnosis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One of the participants in the liner group was excluded from the study at the beginning as he developed type-II diabetes. The total number of participants in the liner group was thus 22 at baseline.

Reporting Groups
  Description
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.
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.

Participant Flow for 3 periods

Period 1:   Start of Study
    Splinting Application   Splint Liner Application
STARTED   23 [1]   22 [2] 
COMPLETED   23   22 
NOT COMPLETED   0   0 
[1] minor comfort issues were reported within the first 2 weeks of the trial
[2] No comfort issues reported.

Period 2:   Follow-up at Week 3 of the Trial
    Splinting Application   Splint Liner Application
STARTED   23 [1]   22 [2] 
COMPLETED   17   21 
NOT COMPLETED   6   1 
Withdrawal by Subject                3                1 
Lost to Follow-up                3                0 
[1] 3 participants discontinued the trial, 3 failed to return for additional follow-ups.
[2] one participant failed to return for the 3 week follow-up

Period 3:   Follow-up at Week 6 of the Trial
    Splinting Application   Splint Liner Application
STARTED   17   21 [1] 
COMPLETED   16 [2]   19 
NOT COMPLETED   1   2 
Lost to Follow-up                1                2 
[1] 2 participants did not return for their final follow-up
[2] 2 people who missed the first follow-up, returned for the final follow-up at week 6 (n=18).



  Baseline Characteristics

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
  Description
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 
Overall Participants Analyzed 
[Units: Participants]
 23   22   45 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   23   22   45 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.65  (8.04)   46.09  (7.71)   48.42  (8.13) 
Gender 
[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 [1] 
[Units: Log (copies/ml)]
Log Mean (Standard Deviation)
 2.25  (1.08)   1.96  (0.75)   2.10  (0.93) 
Years living with HIV [1] 
[Units: Years]
Mean (Standard Deviation)
 11.30  (6.01)   10.32  (7.62)   10.82  (6.79) 
Pain scores [1] 
[Units: Scores on a 0-100 scale.]
Mean (Standard Deviation)
 61.35  (20.98)   60.16  (14.35)   60.77  (17.85) 
Sleep Scores [1] 
[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 [1] 
[Units: Centimeters (cm)]
Mean (Standard Deviation)
 35.31  (6.45)   36.88  (8.36)   36.07  (7.37) 
Function-Walking Distance [1] 
[Units: Meters (m)]
Mean (Standard Deviation)
 246.00  (133.71)   241.89  (151.46)   243.99  (141.04) 


  Outcome Measures

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 ]
  Hide Outcome Measure 3

Measure Type Primary
Measure Title Sleep Quality/Quantity Scores (PSQI)
Measure Description 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.
Time Frame week 3  

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.
The number of participants returning for the first follow-up with complete data.

Reporting Groups
  Description
Splinting Application 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.

Measured Values
   Splinting Application   Splint Liner Application 
Participants Analyzed   16   21 
Sleep Quality/Quantity Scores (PSQI) 
[Units: Scores ranging 0-21, 0=no disturbances]
Mean (Standard Deviation)
 13.13  (4.51)   14.29  (4.58) 

No statistical analysis provided for Sleep Quality/Quantity Scores (PSQI)



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

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.


  More Information