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
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
AIDS
Peripheral Neuropathy
Pain
Sleep
Interventions: Device: Splinting application to the lower extremities
Device: Splint liner application

  Participant Flow
  Hide 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


  Outcome Measures
  Show All 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 ]

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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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.  


Results Point of Contact:  
Name/Title: Roberto Sandoval PT
Organization: Texas Woman's University
phone: 713-859-9351
e-mail: rsandoval@mail.twu.edu


Publications:

Responsible Party: Robert Sandoval, 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