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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
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
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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
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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
  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  
Number of Participants  
[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 [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 ]

Measure Type Primary
Measure Title Pain Scores at Week 3
Measure Description 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.
Time Frame Week 3  
Safety Issue No  

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 total number of participants returning for the first follow-up at week three with complete data.

Reporting Groups
  Description
Lower Extremity Splinting Application nighttime splint application to the lower extremities
Splint Liner Night time application of lower extremity splint liner

Measured Values
    Lower Extremity Splinting Application     Splint Liner  
Number of Participants Analyzed  
[units: participants]
  16     21  
Pain Scores at Week 3  
[units: units on a scale 0-100 (0= no pain)]
Mean ± Standard Deviation
  50.53  ± 16.48     53.76  ± 15.41  

No statistical analysis provided for Pain Scores at Week 3



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

Measure Type Primary
Measure Title Pain Scores
Measure Description 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.
Time Frame Week 6  
Safety Issue No  

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 total number of participants that completed the 6 week trial in each investigational group

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  
Number of Participants Analyzed  
[units: participants]
  18     19  
Pain Scores  
[units: units on a scale 0-100 (0=no pain)]
Mean ± Standard Deviation
  40.22  ± 18.57     49.89  ± 21.72  


Statistical Analysis 1 for Pain Scores
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.001
Mean Difference (Final Values) [4] 45.19
Standard Deviation ± 20.25
95% Confidence Interval ( 38.33 to 52.05 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  A repeated measure ANOVA was performed to evaluate the contrasts of interest.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Sphericity was not tenable for the factor pain scores, degrees of freedom were corrected using Huynh-Feldt estimates, df (1.71,56.46).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Pain Scores
Groups [1] Splinting Application
Method [2] t-test, 2 sided
P Value [3] <0.0005
Mean Difference (Final Values) [4] 16.09
Standard Error of the mean ± 3.60
95% Confidence Interval ( 8.80 to 23.39 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null hypothesis: Is there a difference in baseline pain scores compared to those at week 6 in the splinting group?
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Bonferroni adjustment for significance<0.013.
[4] Other relevant estimation information:
  Paired t-test contrasting pain scores from baseline to week six of the trial-Splint group. The statistical power for the within splint intervention contrast was calculated to be 0.99.

Statistical Analysis 3 for Pain Scores
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.155
Mean Difference (Final Values) [4] -3.23
Standard Error of the mean ± 5.27
95% Confidence Interval ( -13.93 to 7.47 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is not difference in pain scores between the liner and splint applications at week three.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  df(35)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Bonferroni adjustment for significance<0.013.
[4] Other relevant estimation information:
  The statistical power for the between intervention contrast was calculated to be 0.26

Statistical Analysis 4 for Pain Scores
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.155
Mean Difference (Final Values) [4] -9.67
Standard Error of the mean ± 6.66
95% Confidence Interval ( -23.20 to 3.85 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no difference in pain scores between the liner and splint applications at week six.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  df(35)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



3.  Primary:   Sleep Quality/Quantity Scores (PSQI)   [ Time Frame: week 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  
Safety Issue No  

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  
Number of Participants Analyzed  
[units: participants]
  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 ]

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. Buysse et al. reported sensitivity and specificity values of 89.6% and 86.5%, respectively for this scale in identifying good and poor sleepers.
Time Frame week 6  
Safety Issue No  

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 second follow-up

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, patients will be blinded to this arm of the study.

Measured Values
    Splinting Application     Splint Liner Application  
Number of Participants Analyzed  
[units: participants]
  18     19  
Sleep Quality/Quantity Scores (PSQI)  
[units: Scores ranging 0-21, 0=no disturbances]
Mean ± Standard Deviation
  12.06  ± 4.84     11.95  ± 5.57  

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



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

Measure Type Secondary
Measure Title Function-Reach
Measure Description

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.

Time Frame week 3  
Safety Issue No  

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. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.

Reporting Groups
  Description
Lower Extremity Splinting Application nighttime splint application to the lower extremities
Splint Liner Night time application of lower extremity splint liner

Measured Values
    Lower Extremity Splinting Application     Splint Liner  
Number of Participants Analyzed  
[units: participants]
  16     20  
Function-Reach  
[units: Centimeters (cm)]
Mean ± Standard Deviation
  38.76  ± 6.76     38.35  ± 7.04  

No statistical analysis provided for Function-Reach



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

Measure Type Secondary
Measure Title Function-Reach
Measure Description

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.

Time Frame week 6  
Safety Issue No  

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. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.

Reporting Groups
  Description
Lower Extremity Splinting Application nighttime splint application to the lower extremities
Splint Liner Night time application of lower extremity splint liner

Measured Values
    Lower Extremity Splinting Application     Splint Liner  
Number of Participants Analyzed  
[units: participants]
  18     18  
Function-Reach  
[units: Centimeters (cm)]
Mean ± Standard Deviation
  40.00  ± 6.22     39.34  ± 6.22  

No statistical analysis provided for Function-Reach



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

Measure Type Secondary
Measure Title Function-Walking Distance
Measure Description

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.

Time Frame week 3  
Safety Issue No  

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 3 week follow-up with complete data

Reporting Groups
  Description
Lower Extremity Splinting Application nighttime splint application to the lower extremities
Splint Liner Night time application of lower extremity splint liner

Measured Values
    Lower Extremity Splinting Application     Splint Liner  
Number of Participants Analyzed  
[units: participants]
  16     19  
Function-Walking Distance  
[units: Meters (m)]
Mean ± Standard Deviation
  255.84  ± 143.58     263.52  ± 156.74  

No statistical analysis provided for Function-Walking Distance



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

Measure Type Secondary
Measure Title Function-Walking Distance
Measure Description

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.

Time Frame week 6  
Safety Issue No  

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 6 week follow-up

Reporting Groups
  Description
Lower Extremity Splinting Application nighttime splint application to the lower extremities
Splint Liner Night time application of lower extremity splint liner

Measured Values
    Lower Extremity Splinting Application     Splint Liner  
Number of Participants Analyzed  
[units: participants]
  18     19  
Function-Walking Distance  
[units: Meters (m)]
Mean ± Standard Deviation
  279.52  ± 146.61     304.90  ± 137.63  

No statistical analysis provided for Function-Walking Distance




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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.


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